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{
"NCT_ID" : "NCT00739414",
"Brief_Title" : "Dose-escalating Study of LBH589 in Adult Patients With Advanced Solid Tumors",
"Official_title" : "A Phase IA, Dose-escalating Study of LBH589 Administered Intravenously in Adult Patients With Advanced Solid Tumors",
"Conditions" : ["Cancer", "Advanced Solid Tumor"],
"Interventions" : ["Drug: LBH589"],
"Location_Countries" : ["Japan"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NON_RANDOMIZED",
"Interventional Model" : "SINGLE_GROUP",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
This study will characterize the safety, tolerability, biological activity, and pharmacokinetics of LBH589 in Japanese patients with advanced solid tumors whose disease has progressed despite standard therapies, or for whom no standard therapy exists.
#Intervention
- DRUG : LBH589
- 10, 15, 20 mg/m2, i.v. on day 1 and 8 of each 21 day cycle
- Other Names :
- Panobinostat
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients with histologically or cytologically confirmed, advanced solid tumors whose disease has progressed despite available standard therapies, or for which no standard therapy exists.
* At least one measurable or non-measurable lesion as defined by modified RECIST Criteria for solid tumors
* Age >=20 years
* World Health Organization (WHO) Performance Status of <=2
* Patients must have the following laboratory values as defined in protocol
* Life expectancy of >= 12 weeks
* Written informed consent obtained
Exclusion Criteria:
* Patients with evidence of CNS tumor or metastasis
* Patients with pleural effusion and/or ascites to be drained
* Patients with any peripheral neuropathy >= CTCAE grade 2
* Impaired cardiac function defined in protocol
* Acute or chronic liver or renal disease
* Other concurrent severe and/or uncontrolled medical conditions that could cause unacceptable safety risks or compromise compliance with the protocol
* Patients who are currently receiving treatment with any of the medications which have the potential to prolong the QT interval and the treatment cannot be either discontinued or switched to a different medication
* Patients who have received chemotherapy <=4 weeks prior to starting study drug or who have not recovered from side effects of such therapy
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT00739414
| 14,776
|
{
"NCT_ID" : "NCT03417154",
"Brief_Title" : "Nivolumab and Oral Cyclophosphamide for R/R AML and HIgh Risk MDS",
"Official_title" : "Nivolumab and Oral Cyclophosphamide for Relapsed/Refractory Acute Myeloid Leukemia (AML) and Higher-Risk Myelodysplastic Syndrome (MDS)",
"Conditions" : ["Acute Myeloid Leukemia", "Higher Risk Myelodysplastic Syndrome"],
"Interventions" : ["Drug: Low dose Cyclophosphamide (CTX) Daily", "Drug: Nivolumab", "Drug: Low dose Cyclophosphamide (CTX) Every 7 Days"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional Model" : "PARALLEL",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
This is a phase II trial of nivolumab and low dose cyclophosphamide (CTX) when given in combination to patients with relapsed/refractory acute myeloid leukemia (AML) and higher-risk myelodysplastic syndrome (MDS) who are not eligible for or decline hematopoietic stem cell transplant. It includes a randomized pilot sub-study during stage 1.
#Intervention
- DRUG : Nivolumab
- 3mg/kg IV (or if prior alloHSCT, 1 mg/kg) over 30 minutes every 14 days on Days 1 and 15 for up to four 28-day courses.
- Other Names :
- Opdivo
- DRUG : Low dose Cyclophosphamide (CTX) Daily
- Oral cyclophosphamide 50mg + nivolumab 3 mg/kg IV every 2 weeks for up to 4 courses of treatment
- Other Names :
- CTX
- DRUG : Low dose Cyclophosphamide (CTX) Every 7 Days
- Oral cyclophosphamide 350 mg every 7 days + nivolumab 3mg/kg IV every 2 weeks for up to 4 courses of treatment
- Other Names :
- CTX
|
#Eligibility Criteria:
Inclusion Criteria:
* >=18 years
* Meets one of the following disease criteria:
* Primary (de novo) AML or higher-risk MDS with induction failure: No CR after 2 or more induction attempts with high dose chemotherapy or hypomethylating agents or other agents; no CR after 1 induction attempt and not eligible for a 2nd induction.. Higher risk MDS defined as risk score > 4.5 based on the revised IPSS criteria.
* Secondary AML (from antecedent hematologic malignancy or treatment-related): Not in CR after 1 or more cycles of chemotherapy.
* Relapsed AML: Blasts >=5% in bone marrow or peripheral blood after prior attainment of CR; relapse at any time but currently >=100 days following allogeneic HCT.
* Relapsed MDS: Morphologic evidence of relapse or increase in blasts >=5% in bone marrow or peripheral blood after prior attainment of hematologic improvement; or partial or complete response ; relapse at any time but currently >=100 days following allogeneic HCT..
* ECOG Performance Status <= 2 - refer to Appendix II
* Adequate organ function within 14 days of study registration defined as:
* Absolute Lymphocyte Count: >= 500 cells/mm3
* Hepatic: total bilirubin <= 3 x upper limit of institutional normal (ULN); ALT and AST <= 5 x ULN
* Renal: Serum creatinine <= 2 mg/dL
* Pulmonary: No oxygen requirement on room air or requiring <= 2L supplemental O2
* Sexually active females of child bearing potential and males with partners of child bearing potential must agree to use effective contraception during therapy and continuing (23 weeks for females, 31 weeks for males) after the last dose of nivolumab
* Voluntary written consent
Exclusion Criteria:
* Pregnant or breastfeeding -The agents used in this study fall under Pregnancy Category D - Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. Women of childbearing potential must have a negative pregnancy test (urine or serum) within 7 days of study drug administration.
* Prior allogeneic hematopoietic stem cell transplantation within previous 100 days (note patients with a prior alloHSCT receive nivolumab at the reduced dose of 1 mg/kg)
* Signs or symptoms of active graft versus host disease
* Active pneumonitis or uncontrolled infection
* Received chemotherapy drugs within previous 2 weeks
* Estimated life expectancy <28 days in the opinion of the enrolling investigator
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT03417154
| 37,772
|
{
"NCT_ID" : "NCT03415854",
"Brief_Title" : "Paclitaxel Protein Bound Plus Cisplatin Plus Gemcitabine and Paricalcitol for Pancreatic Adenocarcinoma (NABPLAGEMD)",
"Official_title" : "A Phase II Pilot Trial Of Paclitaxel Protein Bound Plus Cisplatin Plus Gemcitabine and the Addition Of Paricalcitol Upon Disease Progression in Patients With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma (NABPLAGEMD)",
"Conditions" : ["Pancreatic Cancer", "Pancreatic Ductal Adenocarcinoma", "Pancreatic Adenocarcinoma", "Pancreas Metastases", "Adenocarcinoma"],
"Interventions" : ["Drug: Paricalcitol (Zemplar)"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional Model" : "SINGLE_GROUP",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
The purpose of this study is to determine if the combination of paclitaxel protein bound, gemcitabine, cisplatin, paricalcitol are effective in individuals with previously untreated metastatic pancreatic cancer.
Detailed Description
Pancreatic cancer continues to be a highly lethal disease with an overall 5 year survival of only 8%. Since 2004, the incidence of pancreatic cancer has been increasing by 1.5% per year and it is estimated that there will be 53,670 new cases diagnosed in the United States in 2017, with 43,090 expected deaths. Pancreatic cancer is the third most common cause of cancer-related deaths in both men and women, and the incidence is about equal in both sexes. Of all types of pancreatic cancers, pancreatic ductal adenocarcinoma (PDA) is by far the most common, representing 80% of cases. Due to lack of adequate screening techniques, greater than 80% of patients at the time of diagnosis present with unresectable, advanced disease. Standard treatment options for inoperable patients with locally advanced and metastatic PDA have been quite limited. Gemcitabine monotherapy, approved by the Food and Drug Administration (FDA) in 1996, demonstrated a median survival of 5.7 months, and has been the mainstay in treating patients with PDA. The first combination regimen to demonstrate any survival benefit compared with gemcitabine alone was gemcitabine plus erlotinib, with median survival of 6.24 months versus 5.91 months for single agent gemcitabine.
A meta-analysis of randomized trials by Heinemann and colleagues showed that patients with advanced pancreatic cancer and a good performance status may benefit from combination chemotherapy with gemcitabine plus a platinum agent or a fluoropyrimidine. Multiple combination regimens are being utilized.
Recently, the regimen of 5-fluorouracil/leucovorin/irinotecan/oxaliplatin (FOLFIRINOX) compared with gemcitabine demonstrated improvement in both progression-free survival (PFS, 6.4 vs. 3.3 months) and overall survival (OS, 11.1 vs. 6.8 months) for patients with a good performance status. FOLFIRINOX, however, is associated with substantial grade 3 and 4 toxicities, including diarrhea, nausea, vomiting, fatigue, neutropenia and febrile neutropenia, and cannot be given to patients \>76 years of age or in some cases patients with head of the pancreas tumors. An international phase III trial comparing paclitaxel protein bound (now called paclitaxel protein bound) plus gemcitabine to gemcitabine single agent demonstrated a statistically significant improvement in OS (8.5 vs. 6.7 months) for advanced pancreatic cancer patients using the gemcitabine and paclitaxel protein bound over gemcitabine alone.
A recently completed phase Ib/II trial of the combination of paclitaxel protein bound plus gemcitabine plus cisplatin in previously untreated stage IV pancreatic adenocarcinoma patients was presented at the 2017 Gastrointestinal Cancer Symposium. In 24 patients with stage IV pancreatic cancer they reported 8.3% complete response (CR), 62.5% partial response (PR), 16.7% stable disease and 12.5% progressive disease. The rationale for adding cisplatin to paclitaxel protein bound and gemcitabine is that in a study of 1,029 patients whose pancreatic cancer tumors underwent molecular profiling, 57% of these tumors were negative for expression of the excision repair cross-complementation group 1 (ERCC1), indicating sensitivity to a platinum anti-tumor agent. In addition to the above, in our whole genome/transcriptome sequencing analysis, we found that abnormal repair pathways were a feature of all of the pancreatic cancers that were sequenced. Cisplatin prevents cellular deoxyribonucleic acid (DNA) repair by binding to and causing crosslinking of DNA, triggering apoptosis. Cisplatin has been used in other combination regimens to treat patients with PDA. For example, the cisplatin, epirubicin, 5-fluorouracil and gemcitabine (PEFG) regimen had an acceptable toxicity profile and was associated with a 24% partial response rate, 5 month PFS and 8.3 month OS as second line therapy.
Most recently, a study showed that Vitamin D can change the pancreatic tumor microenvironment from an immunologically suppressive (tumor promoting) one to an immunologically hostile one (e.g. decreased IL-6, decreased CXCL12 etc.). In addition, in the same study, the vitamin D ligand calcipotriol decreased production of collagen, decreased myeloid derived suppressor cells (MDSCs) and decreased regulatory T cells. Remarkably, in clinical practice, the vitamin D analogue paricalcitol was observed to reverse chemotherapy resistance. Two individuals with pancreatic adenocarcinoma who were receiving paclitaxel protein bound and gemcitabine based combination chemotherapy developed progressive disease which was reversed by the addition of paricalcitol.
Based upon these promising clinical and pre-clinical data we are initiating a clinical trial combining paclitaxel protein bound, gemcitabine, and cisplatin for patients with metastatic PDA. When these patients develop progressive disease the vitamin D analog paricalcitol will be added to the regimen. The treatment will continue until further disease progression.
#Intervention
- DRUG : Paricalcitol (Zemplar)
- combination therapy
- Other Names :
- Cisplatin (Platinol), Paclitaxel Protein Bound (Abraxane), Gemcitabine (Gemzar)
|
#Eligibility Criteria:
Inclusion Criteria:
* Age >=18 years; male or female.
* Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma.
* Capable of providing informed consent and complying with trial procedures including obtaining paired biopsies during therapy
* Karnofsky Performance Status (KPS) of >= 70%.
* Life expectancy >= 12 weeks.
* Measurable tumor lesions according to RECIST 1.1 criteria.
* Women must agree not to become pregnant (e.g. post-menopausal for at least 1 year, surgically sterile, or practicing adequate birth control methods) for the duration of the study and until 90 days after last dose of study treatment. Women of child bearing potential must have a negative serum or urine pregnancy test at the Screening Visit and be non-lactating. Both male and female patients of reproductive potential must agree to use a reliable method of birth control during the study.
Exclusion Criteria:
* Patients must have received no previous radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of metastatic disease. Prior treatments in the adjuvant setting with gemcitabine and/or Fluorouracil (5-FU) or gemcitabine administered as a radiation sensitizer are allowed, provided at least 6 months have elapsed since completion of the last dose and no lingering toxicities are present.
* Palliative surgery and/or radiation treatment less than 4 weeks prior to initiation of study treatment.
* Exposure to any investigational agent within 4 weeks prior to initiation of study treatment.
* Evidence of central nervous system (CNS) metastasis (negative imaging study, if clinically indicated, within 4 weeks of Screening Visit).
* History of other malignancies (except cured basal or squamous cell carcinoma, superficial bladder cancer, prostate cancer in active surveillance, or carcinoma in situ of the cervix) unless documented free of cancer for >=2 years.
* Laboratory values: Screening serum creatinine >1.5 mg/dL; total bilirubin > (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) >= 2.5x ULN or >= 5.0×ULN if liver metastases are present; absolute neutrophil count <1,500/mm3, platelet concentration <100,000/mm3, hematocrit level <27% for females or <30% for males, or coagulation tests (prothrombin time [PT], partial thromboplastin time [PTT], International Normalized Ratio [INR]) >1.5×ULN unless on anticoagulation agents.
* Current, serious, clinically significant cardiac arrhythmias as determined by the investigator.
* History of HIV infection.
* Active, clinically significant serious infection requiring treatment with antibiotics, antivirals or anti-fungals.
* Any condition that might interfere with the patient's participation in the study or in the evaluation of the study results.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT03415854
| 39,688
|
{
"NCT_ID" : "NCT01516489",
"Brief_Title" : "Improving Fecal Occult Blood Test Completion Rates Among Veterans",
"Official_title" : "Improving Fecal Occult Blood Test Completion Rates Among Veterans",
"Conditions" : ["Colorectal Cancer"],
"Interventions" : ["Behavioral: Stage 1", "Behavioral: Stage 2"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1", "PHASE2"],
"Primary_Purpose" : "PREVENTION",
"Allocation" : "RANDOMIZED",
"Interventional Model" : "PARALLEL",
"Masking" : "SINGLE"
}
}
|
#Study Description
Brief Summary
This is a 4-arm cluster randomized controlled trial to evaluate whether patient financial incentives directly integrated into primary care can improve fecal occult blood test (FOBT) completion rates. We will recruit primary care patients at the Philadelphia Veterans Affairs Medical Center (PVAMC) in 2 stages. In stage 1, we hypothesize that, compared to usual care, $5, $10, $20 incentives will each lead to a statistically significant increase in the rate of FOBT completion. We also hypothesize that there will be a direct dose-response relationship between the incentive amount and rates of FOBT completion. In stage 2, we hypothesize that a lottery-based incentive and a raffle-based incentive will both lead to a statistically significant increase in the rate of FOBT completion compared to a fixed payment incentive with an equivalent dollar per patient value.
#Intervention
- BEHAVIORAL : Stage 1
- Patients who are prescribed an FOBT kit in one of the PVAMC Primary Care clinics (i.e., Module B or C) will be randomly assigned by day to one of 4 study arms. All FOBT kits will include a card with a description of the arm that the patient has been randomized to.
- BEHAVIORAL : Stage 2
- Patients who are prescribed an FOBT kit in one of the PVAMC Primary Care clinics (i.e., Module B or C) will be randomly assigned by day to one of 4 study arms. All FOBT kits will include a card with a description of the arm that the patient has been randomized to. The exact dollar amounts for the Voucher-Based Incentive, Lottery-Based Incentive, and Raffle-Based Incentive arms will be based on the results of Stage 1.
|
#Eligibility Criteria:
Inclusion Criteria:
* PVAMC outpatients who are prescribed an FOBT kit in Module B or C during the study period.
Exclusion Criteria:
* None. All PVAMC outpatients who are prescribed an FOBT kit in Module B or C during the study period will be eligible.
Sex :
MALE
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT01516489
| 1,280
|
{
"NCT_ID" : "NCT00309088",
"Brief_Title" : "FK506 Phase 3 Study: a Study for Steroid Non-resistant Myasthenia Gravis (MG) Patients",
"Official_title" : "FK506 Phase 3 Study: a Double Blind Placebo Controlled Study for Steroid Non-Resistant Myasthenia Gravis Patients",
"Conditions" : ["Myasthenia Gravis"],
"Interventions" : ["Drug: placebo", "Drug: tacrolimus"],
"Location_Countries" : ["Japan"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE3"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional Model" : "PARALLEL",
"Masking" : "QUADRUPLE"
}
}
|
#Study Description
Brief Summary
The purpose of the study is to investigate the efficacy and safety for steroid non-resistant MG patients in a double blind, placebo controlled study.
#Intervention
- DRUG : tacrolimus
- oral
- Other Names :
- Prograf, FK506
- DRUG : placebo
- oral
|
#Eligibility Criteria:
Inclusion Criteria:
* Clinically diagnosed as myasthenia gravis
* Those whose MG symptoms are well-controlled by the treatment with prednisone
* Steroid non-refractory Myasthenia Gravis: ≧20mg and ≦40mg / alternate day of steroid dose required to maintain
Exclusion Criteria:
* Those who have thymoma or the history of thymoma (Masaoka stage III or IV)
* Patients who received steroid pulse therapy, plasma exchange therapy, globulin therapy or radiation therapy within 12 weeks prior to the initiation of test drug
* Patients who started the immunosuppressant therapy or increased the dose of immunosuppressant within 12 weeks prior to the initiation of test drug.
* Patients who had undergone thymectomy within 24 weeks prior to the initiation of test drug.
* Pancreatitis or diabetes
* Serum creatinine≦1.5mg/dL
Sex :
ALL
Ages :
- Minimum Age : 16 Years
- Maximum Age : 64 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT00309088
| 33,946
|
{
"NCT_ID" : "NCT01101360",
"Brief_Title" : "Port Wine Stains Treatment Matrix RF Study",
"Official_title" : "Evaluation of Fractional Radiofrequency (Matrix RF) Stand Alone and Combined With PDL Treatment on Port Wine Stains",
"Conditions" : ["Port Wine Stains"],
"Interventions" : ["Device: Matrix RF", "Device: Pulse Dye Laser followed by Matrix RF", "Device: Matrix RF followed by Pulse Dye Laser"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional Model" : "SINGLE_GROUP",
"Masking" : "SINGLE"
}
}
|
#Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of the Matrix RF for Port Wine Stains based on clinical and histological analyses.
#Intervention
- DEVICE : Matrix RF
- Section of port wine stain to be treated 5 times every 5 weeks (+/- 1 week)
- DEVICE : Matrix RF followed by Pulse Dye Laser
- Section of port wine stain to be treated 5 times every 5 weeks (+/- 1 week)
- DEVICE : Pulse Dye Laser followed by Matrix RF
- Section of port wine stain to be treated 5 times every 5 weeks (+/- 1 week)
|
#Eligibility Criteria:
Inclusion Criteria:
* Informed consent agreement signed by the subject.
* Healthy males or females older than 18 <= age <= 65 of age.
* Having a low to mid depth Port Wine Stain of at least 5 cm2.
* Willingness to follow the treatment and follow-up schedule and the post-treatment care.
* For female candidates - post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study (i.e., oral contraceptives, IUD, contraceptive implant, barrier methods with spermicide, or abstinence).
Exclusion Criteria:
* PWS on lower legs or hands.
* Pregnant and/or breastfeeding.
* Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator.
* Having a permanent implant in the treated area, such as an injected chemical substance in the face (if treated).
* Having a history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treated area, unless treatment is conducted following a prophylactic regimen.
* Use of non-steroidal anti-inflammatory drugs (NSAIDS, e.g., ibuprofen-containing agents) one week before and after each treatment session.
* Use of retinoids, antioxidants or medical grade of skin nourishing supplements within 2 months of treatment or during the study.
* Having received a facial dermabrasion or chemical peel treatment within 3 months of treatment or during the study (if face is treated).
* Having received treatment with light, RF or other devices in the treated area within 6 months of treatment or during the study.
* Having received Botox/collagen/fat injections or other methods of augmentation with injected or implanted material in the treated area within 9 months of treatment or during the study (if face is treated).
* Having undergone a resurfacing procedure, face lift or eyelid surgery within a year of treatment or during the study (if face is treated).
* Having undergone any other surgery in the treated area within 6 months of treatment (or more if skin has not healed completely) or during the study.
* History of keloid scarring or of abnormal wound healing.
* Suffering from current or history of significant skin conditions in the treated area or inflammatory skin conditions, including, but not limited to: active acne, excessive skin dryness, psoriasis, eczema, rash, rosacea (particularly severe open wound stage), varicella scars, open lacerations or abrasions and active cold sores or herpes sores prior to treatment (duration of resolution as per the Investigator's discretion) or during the treatment course.
* History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications.
* History of epidermal or dermal disorders (particularly if involving collagen or microvascularity).
* History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation.
* Suffering from hormonal imbalance, as per the Investigator's discretion.
* Having a known anticoagulative or thromboembolic condition or taking anticoagulation medications one week prior to and during the treatment course (to allow inclusion, temporary cessation of use as per the subject's physician discretion).
* Having or undergoing any form of treatment for active cancer, or having a history of skin cancer or any other cancer in the areas to be treated, including actinic keratosis, presence of malignant or pre-malignant pigmented lesions.
* Suffering from significant concurrent illness, such as cardiac disorders, diabetes (type I or II), or pertinent neurological disorders.
* Tattoo or permanent make-up in the treated area.
* Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study.
* Participation in a study of another device or drug within three month prior to enrollment or during the study.
* As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT01101360
| 5,547
|
{
"NCT_ID" : "NCT00604526",
"Brief_Title" : "High Dose Rate Prostate Brachytherapy as Salvage for Locally Recurrent Prostate Cancer Previously Treated With External Beam Radiotherapy",
"Official_title" : "Pilot Study of High Dose Rate Prostate Brachytherapy as Salvage for Locally Recurrent Prostate Cancer Previously Treated With External Beam Radiotherapy",
"Conditions" : ["Prostate Cancer"],
"Interventions" : ["Radiation: High dose rate (HDR) brachytherapy using Iridium 192 radioactive seeds"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional Model" : "SINGLE_GROUP",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
High dose rate (HDR) brachytherapy is a form of radiation treatment using temporary radioactive seeds. This is done by placing very tiny catheters or tubes into the prostate and then inserting temporary radioactive seeds, called Iridium 192, through these catheters. HDR brachytherapy gives precise radiation to the prostate with less radiation given to the normal tissues near the prostate. For patients who have been treated with external beam radiation to the prostate before, HDR brachytherapy can give radiation again to the prostate without exposing the normal tissues around the prostate to significantly more radiation. This may be safer than giving external beam radiation again. The purpose of this study is to test the safety of high dose rate temporary brachytherapy (HDR) for prostate cancer that has come back after external beam radiation. We want to find out what effects, good and/or bad, the treatment has on you and your recurrent prostate cancer.
#Intervention
- RADIATION : High dose rate (HDR) brachytherapy using Iridium 192 radioactive seeds
- Pre-tx Sexual function questionnaire Quality of Life baseline, Treatment with HDR (Two days) Treatment: Iridium 192 radioactive seeds temporarily inserted into patient. Post treatment (after HDR) Month 1 (+/- 2 weeks), 3 (+/- 1 month), 6 (+/- 1 month), 9 (+/-1 month), 12 (+/- 1 month)\* NCI CTC GU and GI assessment,IPSS, IIEF, PSA lab test, Prostate HRQOL
\*After 1 year, will follow up with doctor about every 6 months.
|
#Eligibility Criteria:
Inclusion Criteria:
* KPS > than or equal to 80
* Able to give informed consent
* Able to complete toxicity scales and questionnaires
* Histologically MSKCC confirmed diagnosis of recurrent prostate cancer.
* Documented history of definitive radiotherapy to the prostate gland
* IPSS of < than or equal to 15 at the time of evaluation
* PSA < than or equal to 15 ng/ml
* Organ confined disease
Exclusion Criteria:
* Unable to tolerate general anesthesia
* Abnormal complete blood count. Any of the following:
* Platelet count less than 75,000/ml
* Hb level less than 10 gm/dl
* WBC less than 3.5/ml
* Abnormal coagulation profile:
* INR > 2.5
* Abnormal Liver function tests (>1.5 x normal value)
* Abnormal renal function tests (creatinine > 1.5)
* Evidence of metastatic disease (bone scan, radiographs, MRI findings)
* Prostate volume > 50 cc
* Unable to meet treatment planning criteria
* History of rectal surgery
* External beam radiation dose to the prostate > 86.4 Gy if standard treatment planning dose constraints were met
* History of inflammatory bowel disease
* Expected survival < 1 year
* Unable to undergo bone scan, CT or MRI evaluation
* Unavailable for regular follow up
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 85 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT00604526
| 186
|
{
"NCT_ID" : "NCT03197389",
"Brief_Title" : "Effect of Pembrolizumab (Keytruda®) on Biomarkers in Early Breast Cancer.",
"Official_title" : "Effect of Pembrolizumab (Keytruda®) on Biomarkers Related to Intratumoral Immunity, Proliferation and Apoptosis in Early Breast Cancer.",
"Conditions" : ["Breast Cancer", "Triple Negative Breast Cancer", "Hormone Receptor Negative Neoplasm"],
"Interventions" : ["Drug: Pembrolizumab"],
"Location_Countries" : ["Belgium"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["EARLY_PHASE1"],
"Primary_Purpose" : "BASIC_SCIENCE",
"Allocation" : "NON_RANDOMIZED",
"Interventional Model" : "SINGLE_GROUP",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
The study consists of 2 parts: a retrospective study, and a prospective clinical study with pembrolizumab (Keytruda®) (Phase 0).
1. Retrospective study (S58910):
This is a retrospective analysis to study the expression of PD-L1 in ER/PR negative breast tumors and to correlate this PD-L1 expression with tumor infiltrating lymphocytes (TILs), proliferation, expression of apoptosis and clinical outcome (development of distant metastases).
2. Phase 0 study:
This is a Phase 0 single center, open-label, non-randomized, study in patients with early breast cancer. Patients will be treated with one injection of Pembrolizumab (Keytruda®) administered intravenously at 200 mg 10 +/- 4 days before surgery. This phase 0 study will consist of 2 cohorts; cohort A will include patients who are scheduled for upfront surgery. Cohort A1 will include patients with Her2 negative tumors, Cohort A2 patients with Her2 positive tumors and Cohort A3 with ER positive tumours. Cohort B will include patients who received neoadjuvant chemotherapy (with anti-Her2 therapy if Her2 positive) and who have clear signs of residual tumor on imaging after finishing neoadjuvant chemotherapy (i.e. on imaging estimated residual tumor size of at least 10 mm). Cohort B1 will include Her2 negative tumors, Cohort B2 Her2 positive tumors and Cohort B3 ER positive tumors. The injection will be given in the oncological outpatient unit. Patients will be monitored carefully for the development of adverse experiences/events. Adverse experiences/events will be evaluated according to criteria outlined in the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.
#Intervention
- DRUG : Pembrolizumab
- Biological: humanized anti-PD-1 monoclonal antibody humanized anti-PD-1 monoclonal antibody is a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, which selectively interferes with the combination of PD-1 with its ligands, PD-L1 and PD-L2.
- Other Names :
- Keytruda
|
#Eligibility Criteria:
Inclusion Criteria:
* Be willing and able to provide written informed consent/assent for the trial.
* Be 18 years on day of signing informed consent.
* Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion if needed. Newly obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on Day 0. Subjects for whom newly obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the Sponsor.
* Have a performance status of 0 or 1 on the ECOG Performance Scale.
* Have non-metastatic operable newly diagnosed primary invasive carcinoma of the breast that is:
1. Histologically confirmed
2. ER/PR negative or ER positive. ER/PR status will be evaluated with Allred score (semi-quantitative measurement) following ASCO CAP guidelines 2009.
3. HER2 negative of positive. HER2 status will be evaluated using IHC followed by FISH with dual probe (ASCO CAP guidelines 2013).
4. Primary tumor size greater than 1 cm, measured by any of clinical examination, mammography, ultrasound or magnetic resonance imaging
5. Any clinical nodal status
* Have evaluable core biopsy for IHC
* Be willing to provide plasma/blood samples
* After neo-adjuvant chemotherapy (cohort B1 and B2) patients must have residual tumor >1cm and must be willing to provide evaluable new tumor biopsy for IHC
* Demonstrate adequate organ function, all screening labs should be performed within 14 days of treatment initiation.
* Female subject of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
* Female subjects of childbearing potential (Section 5.7.2) must be willing to use an adequate method of contraception as outlined in Section 5.7.2 - Contraception, for the course of the study through 120 days after receiving the study medication.
Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
* Male subjects of childbearing potential (Section 5.7.1) must agree to use an adequate method of contraception as outlined in Section 5.7.1- Contraception, until 120 after receiving the study therapy.
Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
Exclusion Criteria:
* Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of receiving the treatment dose.
* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to receiving the trial treatment.
* Has a known history of active TB (Bacillus Tuberculosis)
* Hypersensitivity to pembrolizumab or any of its excipients.
* Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., <= Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
* Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 0 or who has not recovered (i.e., <= Grade 1 or at baseline) from adverse events due to a previously administered agent.
* Note: Subjects with <= Grade 2 neuropathy are an exception to this criterion and may qualify for the study.
* Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
* Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
* Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
* Has known history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
* Has an active infection requiring systemic therapy.
* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
* Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
* Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2 agent or co-inhibitory T-cell receptor therapy (e.g. OX40-CD137, CTLA-4)
* Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
* Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
* Has received a live vaccine within 30 days of planned start of study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 100 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT03197389
| 7,313
|
{
"NCT_ID" : "NCT02635789",
"Brief_Title" : "Phase III Trial of Topical Formulation of Sirolimus to Skin Lesions in Patients With Tuberous Sclerosis Complex (TSC)",
"Official_title" : "A Double-blind, Randomized, Placebo-controlled Phase III Trial to Investigate the Efficacy and Safety of NPC-12G Gel (Topical Formulation of Sirolimus) to Angiofibroma and Other Skin Lesions in Patients With Tuberous Sclerosis Complex",
"Conditions" : ["Tuberous Sclerosis", "Angiofibroma", "Hypomelanotic Macule", "Plaque"],
"Interventions" : ["Drug: NPC-12G gel", "Drug: Placebo gel"],
"Location_Countries" : ["Japan"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE3"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional Model" : "PARALLEL",
"Masking" : "QUADRUPLE"
}
}
|
#Study Description
Brief Summary
The purpose of this trial is to evaluate the efficacy and safety of NPC-12G gel (topical formulation of sirolimus) versus placebo gel to facial angiofibroma and other skin lesions in patients with tuberous sclerosis complex (TSC)
Detailed Description
Tuberous Sclerosis Complex (TSC) is an autosomal dominant hereditary disease that causes benign tumors on the almost whole body (including skin, brain, kidney, lung and heart), behavior disorder as autism, mental retardation and neurologic symptom as epilepsy. Angiofibroma is TSC-specific facial skin lesions, and hamartoma caused by increase of the component of skin connective tissues and blood vessels. Other skin lesions due to TSC are white macule(hypomelanotic macule), plaque, shagreen patch and ungual fibromas. Current therapeutic methods for angiofibroma are laser or surgical treatments, but there are problems as many relapses, deficiency of evidence, change of pigment, scar and risk of infection.
This will be a multicenter, double-blind, randomized, placebo-controlled parallel group trial. The trial has three phases; the screening phase, double-blinded treatment phase, and post-treatment phase. The screening phase comprises a screening visit where subject's initial eligibility will be evaluated. During double-blinded treatment phase, patients who meet all entry criteria for the trial will be randomized into two groups, and they will apply 0.2% NPC-12G gel or placebo gel topically twice a day for 12 weeks.
#Intervention
- DRUG : NPC-12G gel
- NPC-12G gel is administered topically twice a day for 12 weeks
- DRUG : Placebo gel
- NPC-12G gel placebo is administered topically twice a day for 12 weeks
|
#Eligibility Criteria:
Inclusion Criteria:
* Male or female patients 3 years or greater at the time of informed consent
* Patients who are diagnosed as definite diagnosis according to diagnostic criteria for tuberous sclerosis complex (International Tuberous Sclerosis Complex Consensus Conference 2012)
* Patients with three or more papules of angiofibroma ( >= 2 mm in diameter with redness in each) on the face at screening tests
* Patients who are not suitable for therapy with laser or surgery, or who do not want therapy with laser or surgery
* Patients or his/her guardian who give a written informed consent in understanding and willingness after having received enough explanation of the test drug and the current trial plan
Exclusion Criteria:
* Patients who are hard to apply the test drug topically with keeping compliance
* Patients with clinical findings such as erosion, ulcer and eruption on or around the lesion of angiofibroma, which may affect assessment of safety or efficacy
* Patients who are hard to be taken pictures of their lesions adequately in such cases that they may not follow instruction of stillness
* Patients with a history of hypersensitivity to alcohol or allergy to sirolimus
* Patients who have complications such as malignant tumor, infection, serious heart disease, hepatic function disorder, renal function disorder or blood disorders which severity are considered by investigator as grade 2 or more severe with reference to ''Concerning classification criteria for seriousness of adverse drug reactions of medical agents''
* Patients who have complications such as diseases unsuitable for the trial participation, for examples, uncontrolled diabetes (fasting blood glucose level >140 mg/dL or postprandial blood glucose level > 200 mg/dL), dyslipidemia (cholesterol level > 300 mg/dL or > 7.75 mmol/L, triglycerides level > 300 mg/dL or > 3.42 mmol/L), etc.
* Patients who have taken drugs with mTOR inhibitory action including sirolimus, everolimus or temsirolimus within 12 months before the initial registration
* Patients who have applied topical tacrolimus on the lesion of angiofibroma within 3 months before the initial registration
* Patients who have received therapy with laser or surgery to the lesion of angiofibroma within 6 months before the initial registration
* Female patients who may be pregnancy or are lactating
* Patients who cannot agree to take appropriate measures of contraception until completion of post-treatment phase or follow-up period after discontinuation from informed consent
* Patients who have participated in other clinical trial and have taken a trial drug within 6 months before the initial registration
* Others, patients who are considered by the investigator as unsuitable for participation in the trial
Sex :
ALL
Ages :
- Minimum Age : 3 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT02635789
| 8,830
|
{
"NCT_ID" : "NCT02067351",
"Brief_Title" : "Mindfulness-Based Intervention in Breast Cancer Patients Undergoing Chemotherapy",
"Official_title" : "Mindfulness-Based Intervention in Breast Cancer Patients Undergoing Chemotherapy",
"Conditions" : ["Breast Cancer"],
"Interventions" : ["Behavioral: Mindfulness"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "SUPPORTIVE_CARE",
"Allocation" : "NA",
"Interventional Model" : "SINGLE_GROUP",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
There is evidence that mindfulness-based interventions (MBIs) such as meditation, mindfulness-based stress reduction (MBSR) and yoga might improve Quality of Life (QOL) and reduce stress in breast cancer survivors. These interventions are becoming increasingly popular in cancer survivors. However, little is known about the feasibility and effect of MBIs administered during the interval of time of chemotherapy, on QOL and stress. The investigators are planning a MBI intervention study developed specifically for breast cancer survivors receiving chemotherapy (usually 4-5 months) at the investigators institution, for at least 8 sessions combined with at least 8 weeks of home-practice, in 25 women receiving chemotherapy for breast cancer.
#Intervention
- BEHAVIORAL : Mindfulness
- Meditation, body scan, yoga.
|
#Eligibility Criteria:
inclusion criteria:
* Women 20 <= age <= 75 years
* Diagnosed with breast cancer
* Scheduled to begin chemotherapy at Mayo Clinic Rochester
Exclusion criteria
* Pregnant
* Practicing mindfulness
Sex :
FEMALE
Ages :
- Minimum Age : 20 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02067351
| 39,863
|
{
"NCT_ID" : "NCT03722355",
"Brief_Title" : "Hyperfractionated RT With BCNU Versus Conventional RT With BCNU for Supratentorial Malignant Glioma",
"Official_title" : "A Phase III Comparison of Hyperfractionated Radiation Therapy (RT) With BCNU and Conventional RT With BCNU for Supratentorial Malignant Glioma",
"Conditions" : ["Glioma", "Glioblastoma Multiforme", "Astrocytoma"],
"Interventions" : ["Drug: Carmustine", "Radiation: Hyperfractionated RT", "Radiation: Conventional RT"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE3"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional Model" : "PARALLEL",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
Hyperfractionated radiation therapy (RT) to 72.0 Gy with BCNU will be compared to conventional radiation therapy to 60.0 Gy with BCNU to determine if hyperfractionated RT can improve the median survival time of adults with supratentorial malignant gliomas.
#Intervention
- RADIATION : Conventional RT
- Radiation therapy
- RADIATION : Hyperfractionated RT
- Radiation therapy
- DRUG : Carmustine
- Chemotherapy
- Other Names :
- BCNU, Gliadel
|
#Eligibility Criteria:
Inclusion Criteria:
* Histopathologically confirmed glioblastoma multiforme (with areas of necrosis), malignant astrocytoma and astrocytoma with foci of anaplasia
* Karnofsky Performance Score >= 60
* Absolute Neutrophil count >= 1,500
* Platelets >= 100,000
* BUN <= 25
* Creatinine <= 1.5
* Bilirubin <= 2.0
* Hemoglobin >= 10 gm
* SGOT < 2 x upper limit of normal
* SGPT < 2 x upper limit of normal
Exclusion Criteria:
* No prior radiation to the head or neck area, chemotherapy or radiosensitizer
* No malignancy with the past five years except non-melanomatous skin cancer or carcinoma in-situ of the cervix
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT03722355
| 16,621
|
{
"NCT_ID" : "NCT04352530",
"Brief_Title" : "Culturally Appropriate Nutrition Communication for Mexican American Women",
"Official_title" : "Culturally Appropriate Nutrition Communication for Mexican American Women: A Randomized Controlled Trial",
"Conditions" : ["Lifestyle Risk Reduction", "Nutrition Poor", "Chronic Disease", "Obesity", "Cancer, Breast"],
"Interventions" : ["Other: Health Communication"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "PREVENTION",
"Allocation" : "RANDOMIZED",
"Interventional Model" : "PARALLEL",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
A randomized controlled trial to test the effects of culturally appropriate nutrition communication for Mexican American women.
Detailed Description
An unbalanced randomized controlled trial with pre-test and immediate post-test was employed to test the effects of different types of message features and appeals. The study was conducted online with Mexican American women aged 18-29 years old. Messages focused on sugary beverage consumption and the main outcomes were acceptance and receptivity to the message (i.e., perceived effectiveness), perceptions of social norms, and knowledge. The investigators also measured a number of hypothesized mediators and moderators of the effects.
#Intervention
- OTHER : Health Communication
- Spoken word poems set to images performed by youth who wrote the poems. Videos were produced by The Bigger Project and were posted publicly to the Bigger Picture Project website and YouTube. Duration of videos ranges from 2 minutes to 6 minutes.
|
#Eligibility Criteria:
Inclusion Criteria:
* Self-identify as Latina/x or Hispanic
* Self-identify as a woman
* Self-reported as being of age between 18 <= age <= 29 years
* Undergraduate students enrolled in SONA at UC Merced
Exclusion Criteria:
* Not Mexican American
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 29 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT04352530
| 12,392
|
{
"NCT_ID" : "NCT01186601",
"Brief_Title" : "Exploration of Tumor Accumulation of BAY94-9392 in Patients With Cancer",
"Official_title" : "Open-label Study for an Exploration of Tumor Accumulation of the 18F Labeled PET/CT (Positron Emission Tomography / Computed Tomography) Tracer BAY94-9392 Following a Single Intravenous Administration of 300 MBq (Corresponding to </= 0.1 mg Total Quantity) in Patients With Prostate Cancer or Other Malignant Tumors",
"Conditions" : ["Neoplasms"],
"Interventions" : ["Drug: PET tracer (BAY94-9392)"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "DIAGNOSTIC",
"Allocation" : "NA",
"Interventional Model" : "SINGLE_GROUP",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
The study will be conducted as an open label, single-dose, explorative study with patients with histologically proven cancer and, preferably, tumor positive lesions in previously performed nuclear medicine imaging examinations.
The investigational drug will be given as a single administration in a dose of \</= 0.1 mg BAY94-9392 (300 MBq, +/- 10%). The total duration of the study for each patient will be approximately 8 days.
#Intervention
- DRUG : PET tracer (BAY94-9392)
- A radioactive dose of 300 MBq of the study drug with a total quantity of \</= 0.1 mg will be administered as slow intravenous bolus injection over up to 60 seconds
|
#Eligibility Criteria:
Inclusion Criteria:
* Males/females >= 18 years
* Patients with a diagnosis of primary prostate cancer (biopsy proven) and scheduled for radical prostatectomy or patients with prostate tumor recurrence (Patients with advanced tumor disease and a high likelihood to display lymph node metastasis are to be preferably included.)
* ECOG (Eastern Cooperative Oncology Group) performance status of 0 <= age <= 2, determined within one week prior to treatment with BAY94 <= age <= 9392
* Patient had an [18F]-fluorodeoxyglucose (FDG) PET/CT for detection, or staging, or restaging, or therapy response assessment that still showed tumor mass with high certainty for a cancer such as melanoma, or colorectal cancer, or head & neck cancer for which FDG-PET/CT is used in clinical routine, and the primary cancer disease is histologically confirmed. In case of recurrent disease confirmation of the primary tumor is sufficient
* No clinically relevant deviations in renal function as determined by Cockcroft and Gault method using serum creatinine at screening.
Exclusion Criteria:
* Concurrent severe and/or uncontrolled and/or unstable medical disease other than cancer or inflammation (e.g. poorly controlled diabetes, congestive heart failure, myocardial infarction within 12 months prior to planned injection of BAY94 <= age <= 9392, unstable and uncontrolled hypertension, chronic renal or hepatic disease, severe pulmonary disease) which could compromise participation in the study
* Known sensitivity to the study drug or components of the preparation
* Previous treatment with BAY94 <= age <= 9392 in this study
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 90 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT01186601
| 10,260
|
{
"NCT_ID" : "NCT05091775",
"Brief_Title" : "The Efficacy of Asacol (Mesalazine) Suppository on the Treatment of Diarrhea-Induced Acute Fissure",
"Official_title" : "The Evaluation of the Efficacy of Asacol (Mesalazine) Suppository on the Treatment of Diarrhea-Induced Acute Fissure in Post-Chemotherapy Cancer Patients - A Randomized Controlled Trial",
"Conditions" : ["Fissure in Ano", "Diarrhea"],
"Interventions" : ["Drug: Asacol is used to treat and prevent mild to moderate acute fissure disease"],
"Location_Countries" : ["Iran, Islamic Republic of"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1", "PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional Model" : "PARALLEL",
"Masking" : "SINGLE"
}
}
|
#Study Description
Brief Summary
Anal fissure define as a superficial tearing in mucosa on the anoderm surface distal to dentate line . The most important factor is hard stool passing with trauma to anal mucosa. But, diarrhea diarrhea has been another important etiology that happen after some conditions like gastroenteritis, laxative over use, during chemotherapy, and ulcerative colitis exacerbation . In these conditions, it seems the change of stool PH maybe the main reason of inflammation and ulcer in acute phase.
The treatment of acute is medical management with change in bowel habits and conservative therapy such as local lubricant, local vasodilator, and warm sitz bath to improve blood supply and wound healing.
This research clinical trial is designed to show the effect of Asacol suppository in the management of acute fissure due to diarrhea. The hypothesis of this research clinical trial has been referred to the cause of acute fissure ulcer because of diarrhea.
Detailed Description
The cases with acute anal fissure after diarrhea will included in this research clinical trial. They will be divided in two groups as an interventional group and control by blind randomization allocation. The interventional group will have received Asacol suppository 1 supp every night and Diltiazem jelly (standard management) twice per day. The control group will have received Diltiazem jelly and placebo suppository like interventional group. Both group will have used warm sitz bath with enough hydration for 10 days. Then the patients will have visited by another surgeon after 4 weeks to evaluate the healing of acute anal fissure. Pain will have performed if the patients can tolerate.
#Intervention
- DRUG : Asacol is used to treat and prevent mild to moderate acute fissure disease
- Comparison of two groups after 2 weeks in fissure wound healing, pain relief, pruritus, burning, bleeding, incontinence. Preliminary results of the study show the rate of fissure improvement 6 weeks after treatment, which is observed by clinical examination. Restoration is defined by complete epithelialization of the fissure site without scarring or residual cracks, and the secondary results will be a reduction in the amount of pain and other symptoms.
- Other Names :
- Mesalazine is used to treat and prevent mild to moderate acute fissure disease
|
#Eligibility Criteria:
Inclusion Criteria:
For age between 18 and 65 years are the presence of acute anal fissure (with symptoms less than 6 weeks) following chronic diarrhea and subsequent fissure.
Exclusion Criteria:
* Recurrent fissure with skin appendage.
* Long history of constipation.
* Use of immunosuppressive drugs or corticosteroids.
* Inflammatory bowel disease such as Crohn's disease and ulcerative colitis.
* Pregnancy.
* Grade 3 and 4 hemorrhoids.
* Neurological disease.
* Obsessive-compulsive disorder.
* Previous history of anal surgery
* Skin diseases such as eczema and psoriasis.
* Sexually transmitted infections, tuberculosis.
* Mucosal prolapse.
* Anal fistula and pelvic radiotherapy.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
Yes
|
NCT05091775
| 25,873
|
{
"NCT_ID" : "NCT05372016",
"Brief_Title" : "Evaluate the Immunogenicity and Safety of 9-valent HPV Recombinant Vaccine in Chinese Healthy Females",
"Official_title" : "A Randomized, Double-Blind and Positive-Controlled Phase 3 Study to Evaluate the Immunogenicity and Safety of the 9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Hansenula Polymorpha) in Chinese Female Subjects Aged16-26 Years",
"Conditions" : ["HPV Infections", "Cervical Cancer", "Vulvar Cancer", "Vaginal Cancer", "CIN1", "CIN2", "CIN3", "VaIN1", "VaIN2", "VaIN3", "Genital Wart", "VIN 1", "VIN 2", "VIN 3", "AIS"],
"Interventions" : ["Biological: Active Comparator: GARDASIL ®9", "Biological: Experimental: Experimental: 9-valent Human Papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52, 58)"],
"Location_Countries" : ["China"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE3"],
"Primary_Purpose" : "PREVENTION",
"Allocation" : "RANDOMIZED",
"Interventional Model" : "PARALLEL",
"Masking" : "DOUBLE"
}
}
|
#Study Description
Brief Summary
The study will evaluate the immunogenicity and safety of 9-valent HPV recombinant vaccine in Chinese healthy females16 to 26 years of age.
#Intervention
- BIOLOGICAL : Experimental: Experimental: 9-valent Human Papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52, 58)
- 9vHPV vaccine ,0.5mL, three doses, 0,2,6 months
- BIOLOGICAL : Active Comparator: GARDASIL ®9
- GARDASIL®9 vaccine, 0.5mL, three doses, 0,2,6 months
|
#Eligibility Criteria:
Inclusion Criteria:
(If the '*' option is not met during screening, the visit can be rescheduled)
* Chinese women aged 16 <= age <= 26 who can provide legal identification(If the subject is under 18 years, proof of legal guardian's identity is also required);
* The subject agreed to participate in the study, and voluntarily signs the informed consent;for subjects aged 16 <= age <= 18 years, they and their legal guardian(s) are supposed to understand and sign informed consent form together； supposed to understand and sign informed consent form together
* Subjects are able to understand the study procedures and participate in follow-up according to the study requirements;
* When the subjects were enrolled, the urine pregnancy test was negative, they were not in the lactation period and had no family planning within 7 months after enrollment.2 weeks before included in the study, effective contraceptive measures has been adopted and agreed to in the first seven months after the study (vaccinations after 1 months ago) continue to adopt effective contraceptive measures (effective contraceptive measures including the pill or condoms, etc ); 5.4. Have an acute illness or an acute episode of a chronic illness within 3 days prior to vaccination or the use of antipyretic, analgesic and antiallergic drugs (e.g., acetaminophen, ibuprofen, aspirin, loratadine, cetirizine, etc.);
* *body temperature <37.3# (underarm body temperature)
Exclusion Criteria:
First dose exclusion criteria(If the '*' option is met during screening, the visit can be rescheduled)
* Have been vaccinated with commercially available HPV vaccine in the past or planned to be vaccinated with commercially available HPV vaccine during the study period;Or have participated in a clinical trial of the HPV vaccine;
* Has a history of cervical diseases, such as cervical screening showing abnormal results including CIN or a history of hysterectomy (vaginal or total abdominal hysterectomy) or pelvic radiation therapy. Has a history of genital diseases (such as vulvar intraepithelial neoplasia, vaginal intraepithelial neoplasia, genital warts, vulvar cancer, vaginal cancer and anal cancer, etc.) or has a previous sexual history (including syphilis, gonorrhea, chancre, venereal lymphatic granuloma, granuloma inguinal);
* A history of severe allergies requiring medical intervention, such as anaphylactic shock, anaphylactic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrosis reaction (Arthus reaction), etc;
* Subjects present with immune impairment or have been diagnosed with congenital or acquired immune deficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammatory bowel disease or other autoimmune diseases. Long-term immunosuppressive therapy, e.g., long-term (more than 2 weeks) treatment with glucocorticoids (e.g., prednisone or similar drugs);
* Has been diagnosed with a severe congenital malformation or chronic disease such as Down syndrome, heart disease, liver disease, kidney disease, diabetes, etc., which may interfere with the conduct or completion of the study;
* Participating in other (drug or vaccine) clinical trials prior to enrollment or planning to participate during the study;
* Has been diagnosed with an infectious disease, such as tuberculosis, viral hepatitis and/or HIV infection;
* A history or family history of convulsions, epilepsy, encephalopathy and mental illness;
* Have contraindications to intramuscular injection, such as having been diagnosed with thrombocytopenia, any coagulation disorder or receiving anticoagulant therapy;
* Absence of a spleen, functional absence of a spleen, and absence or removal of a spleen in any case;
* *Have an acute illness or an acute episode of a chronic illness within 3 days prior to vaccination or the use of antipyretic, analgesic and antiallergic drugs (e.g., acetaminophen, ibuprofen, aspirin, loratadine, cetirizine, etc.);
* *Subjects received inactivated or recombinant vaccines within 14 days prior to study enrollment, or attenuated live vaccines within 28 days prior to study enrollment;
* Subject receives any immunoglobulin or blood product within 3 months prior to the first dose of vaccination;
* * after questioning, subjects had fever symptoms (subaxillary body temperature >=37.3#) before the first day of vaccination (within 24 hours before vaccination);
* Blood pressure on physical examination before the first dose of vaccination was higher than normal or increased (for subjects aged 16 <= age <= 17 year，systolic blood pressure >=120mmHgand/or diastolic blood pressure >=80mmHg，for subjects aged 18 year and above，systolic blood pressure >=140mmHgand/or diastolic blood pressure >=90mmHg);
* Subjects may be unable to comply with the study procedure, comply with the agreement, or plan to permanently relocate from the region prior to completion of the study, or may be permanently absent from the region during the scheduled visit;
* In the opinion of the investigators, the subjects had any other factors that made them unsuitable to participate in the clinical trial.
Sex :
FEMALE
Ages :
- Minimum Age : 16 Years
- Maximum Age : 26 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT05372016
| 17,150
|
{
"NCT_ID" : "NCT03760081",
"Brief_Title" : "A Study to Assess the Safety and Efficacy of ASP1650, a Monoclonal Antibody Targeting Claudin 6 (CLDN6), in Male Subjects With Incurable Platinum Refractory Germ Cell Tumors",
"Official_title" : "A Phase 2, Open-Label, Single-Arm, Multicenter Study to Assess the Safety and Efficacy of ASP1650, a Monoclonal Antibody Targeting Claudin 6 (CLDN6), in Male Subjects With Incurable Platinum Refractory Germ Cell Tumors",
"Conditions" : ["Incurable Platinum Refractory Germ Cell Tumors", "Tumors"],
"Interventions" : ["Drug: ASP1650"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NON_RANDOMIZED",
"Interventional Model" : "SEQUENTIAL",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
The purpose of this study was to establish the recommended phase 2 dose (RP2D) of ASP1650 (Safety Lead-in Phase), as well as, evaluate the efficacy of ASP1650 as measured by confirmed objective response rate (ORR) (phase 2) in participants with incurable platinum refractory germ cell tumors.
This study also evaluated the following efficacy measures for confirmed objective response rate (ORR); clinical benefit rate (CBR); duration of response (DOR); and progression-free survival (PFS); as well as safety and tolerability; the effect of ASP1650 on changes in serum beta human chorionic gonadotropin (βhCG) and alpha-fetoprotein (AFP); and the pharmacokinetics of ASP1650.
Detailed Description
The study consisted of 2 phases: Safety Lead-in phase and phase 2. 19 participants were enrolled in both phases.
The Safety Lead-in phase of this study was to establish the tolerability of RP2D. The RP2D determination was based on at least 6 evaluable participants at the RP2D as determined by the Dose Evaluation Committee (DEC).
Once RP2D had been established as tolerable, 13 additional participants were enrolled in phase 2 to receive ASP1650 for up to a maximum of 12 cycles or until a study discontinuation criteria had been met, whichever occurred earlier.
#Intervention
- DRUG : ASP1650
- Participants received ASP1650 dose level 1 or dose level 2 as intravenous infusion, Q2W starting on C1D1 for up to a maximum of 12 cycles or until study discontinuation criterion was met, whichever occurred earlier. Duration of each treatment cycle was 14 days.
|
#Eligibility Criteria:
Inclusion Criteria:
* A male subject with female partner(s) of child-bearing potential must agree to use contraception during the treatment period and for at least 6 months after the final study drug administration.
* Subject must not donate sperm during the treatment period and for 6 months after the final study treatment administration.
* A male subject with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or time partner is breastfeeding throughout the study period and for 6 months after the final study treatment administration.
* Subject agrees not to participate in another interventional study while receiving study drug in present study.
Disease Specific Criteria:
* Subject has histological evidence of germ cell tumor.
* Subject must have a germ cell tumor that is not amenable to cure with either surgery or chemotherapy.
* Subjects with seminoma and non-seminoma are eligible.
* Subject must have received initial cisplatin based combination chemotherapy AND demonstrated progression following at least 1 salvage regimen for advanced germ cell neoplasm (including relapsed primary mediastinal nonseminomatous germ cell tumor).
1. Initial cisplatin based combination therapy includes bleomycin-etoposide-cisplatin, cisplatin-etoposide, etoposide-ifosfamide-cisplatin or similar regimens.
2. 'Salvage' regimens include high dose chemotherapy, paclitaxel-ifosfamide-cisplatin, vinblastine-ifosfamide cisplatin or similar regimens
3. 'Failure' of prior therapy is defined as: A > 25% increase in the products of perpendicular diameters of measurable tumor masses during prior therapy, which are not amenable to surgical resection; OR the presence of new tumor that are not amenable to surgical resection; OR an increase in alpha-fetoprotein (AFP) or beta human chorionic gonadotropin (βhCG) (>= 50% increase in 2 separate samples collected at least 1 week apart are required if rising tumor markers are the only evidence of failure). NOTE: Subjects with clinically growing teratoma (enlarging mature teratoma arising during or after chemotherapy for a non seminomatous germ-cell tumor and with normal serum levels of AFP and βhCG) should undergo surgical resection if feasible.
* Subjects with late relapse (> 2 years) not amenable to resection are eligible.
* Subjects must have evidence of recurrent or metastatic carcinoma by 1 or more of the following:
1. Subject has measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 within 28 days prior to the first dose of study treatment. For subjects with only 1 measurable lesion and prior radiotherapy, the lesion must be outside the field of prior radiotherapy or must have documented progression following radiation therapy.
2. Subject has a baseline rising tumor marker (AFP or βhCG). NOTE: If a rising tumor marker is the only evidence of progressive disease, at least 2 consecutive rising values at least 1 week apart are needed. Subjects with only evidence of disease as rising tumor marker AFP and βhCG will be assessed for alternate causes of increased serum levels of these markers, such as cross reaction with luteinizing hormone (LH) (can be tested if needed by testosterone suppression of LH), hepatitis, use of marijuana or second primary tumor.
Physical or Laboratory Findings:
* Subject must have an available tumor specimen in a tissue block or unstained serial slides, or subject is an appropriate candidate for tumor biopsy and is amenable to undergoing a tumor biopsy during the screening period.
* Subject has Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
* Subject must meet all of the following criteria based on the centrally analyzed laboratory tests within 14 days prior to the first dose of study treatment. If repeat screening labs are required, local laboratory results can be used to confirm eligibility. In case of multiple central laboratory data within this period, the most recent data should be used to determine eligibility.
1. Hemoglobin >= 8 g/dL
2. Absolute neutrophil count (ANC) >= 1.0 x 109/L
3. Platelets >= 75 x 109/L
4. Albumin >= 2.5 g/dL
5. Total bilirubin <= 2 x upper limit of normal (ULN) or direct bilirubin <= ULN for subjects with total bilirubin levels > 2 x ULN
6. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 2.5 x ULN without liver metastases (or <= 5 x ULN if liver metastases are present)
7. Estimated glomerular filtration rate >= 30 mL/min/1.73 m2
8. Prothrombin time/international normalized ratio (PT/INR) and partial thromboplastin time (PTT) <= 2 x ULN (except for subjects receiving anticoagulation therapy)
Exclusion Criteria:
Prohibited Treatment or Therapies:
* Subject has received systemic immunosuppressive therapy, including systemic corticosteroids within 14 days prior to first dose of study treatment. Subject using a physiologic replacement dose of hydrocortisone or its equivalent (defined as up to 30 mg per day of hydrocortisone or up to 10 mg per day of prednisone) is eligible. Subject who received systemic steroids for asymptomatic central nervous system (CNS) metastases within 14 days prior to first dose of study treatment is eligible.
* Subject has received other investigational agents or devices within 28 days prior to first dose of study treatment.
* Subject has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study day 1 or who has not recovered (i.e., <= grade 1 or at baseline) from adverse event (AE) due to monoclonal antibody (mAb) agents administered more than 4 weeks earlier.
* Subject has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study day 1 or who has not recovered (i.e., <= grade 2 or at baseline) from AEs due to a previously administered agent.
Medical History or Concurrent Disease:
* Subject has prior severe allergic reaction or intolerance to a monoclonal antibody, including humanized or chimeric antibodies requiring permanent discontinuation.
* Subject has known immediate or delayed hypersensitivity, intolerance or contraindication to any component of study treatment.
* Subject has an active human immunodeficiency virus (HIV) infection or known active hepatitis B (HBsAg) or C infection. Subjects with well-controlled HIV infections (i.e., without detectable viral load) are eligible. For subjects who are negative for HBsAg, but hepatitis B core antibody (HBcAb) positive, an HBsAg deoxyribonucleic acid (DNA) test will be performed and if positive, the subject will be excluded. Subjects with positive serology but negative hepatitis C virus (HCV) ribonucleic acid (RNA) test results are eligible.
* Subject has active infection requiring systemic therapy that has not completely resolved within 14 days prior to first dose of study treatment.
* Subject has symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis. Subject with asymptomatic CNS metastases is eligible.
* Subject has had a major surgical procedure and has not completely recovered within 28 days prior to the first dose of study treatment.
* Subject has psychiatric illness or social situations that would preclude study compliance.
* Subject has another malignancy for which treatment is required. Subject with negligible risk of metastasis or death is eligible (e.g., basal or squamous cell skin cancer, localized prostate cancer treated with curative intent or incidental prostate cancer T1-T2a, Gleeson <= 3 + 4, PSA <= 0.5 and who are undergoing active surveillance).
* Subject has any concurrent disease, infection, or co-morbid condition that interferes with the ability of the subject to participate in the study, which places the subject at undue risk or complicates the interpretation of data.
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT03760081
| 13,827
|
{
"NCT_ID" : "NCT03001895",
"Brief_Title" : "Correlation Between SUV on 18F-DCFPyL PET/CT and Gleason Score in Prostate Cancer",
"Official_title" : "Correlation Between SUV on 18F-DCFPyL PET/CT and Gleason Score in Prostate Cancer",
"Conditions" : ["Prostate Cancer"],
"Interventions" : ["Drug: 18F-DCFPyL PET/CT"],
"Location_Countries" : ["Canada"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "DIAGNOSTIC",
"Allocation" : "NA",
"Interventional Model" : "SINGLE_GROUP",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
Prostate specific membrane antigen (PSMA) is a unique membrane bound glycoprotein, which is overexpressed manifold on prostate cancer cells and is well-characterized as an imaging biomarker of prostate cancer. Positron emission tomography / computer tomography (PET/CT) is a nuclear medicine procedure based on the measurement of positron emission from radiolabeled tracer molecules. 18F-DCFPyL is a tracer for prostate cancer PET imaging which binds to PSMA. The strength of functional imaging methods is in distinguishing tissues according to metabolism rather than structure. Studies have shown that PET/CT imaging with 18F-DCFPyL can detect prostate cancer lesions with excellent contrast and a high detection rate even when the level of prostate specific antigen is low.
The objective of this study is to evaluate if the patient-wide SUVmax on 18F-DCFPyL PET/CT in locoregional and metastatic prostate cancer correlates with histopathologic Gleason score at initial biopsy. It is hypothesized that SUVmax will correlate positively with Gleason score. This is of interest because non-invasive risk stratification may be possible in the future.
#Intervention
- DRUG : 18F-DCFPyL PET/CT
- 18F-DCFPyL PET/CT
|
#Eligibility Criteria:
Inclusion Criteria:
* Resident of Canada
* Male sex
* Age >= 18 years
* Previous diagnosis of prostate cancer with Gleason Score available
* ECOG performance status 0 - 3, inclusive
* Able to understand and provide written informed consent
* Under referring physician's care
* Able to tolerate the physical/logistical requirements of a PET/CT scan including lying supine for up to 40 minutes with the arms above the head and tolerating intravenous cannulation
Exclusion Criteria:
* Medically unstable patients (e.g. acute cardiac or respiratory distress or hypotensive, etc.)
* Patients who exceed the safe weight limit of the PET/CT bed (200 kg) or who cannot fit through the PET/CT bore (70 cm diameter)
* Patients with unmanageable claustrophobia
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 120 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT03001895
| 14,926
|
{
"NCT_ID" : "NCT00276029",
"Brief_Title" : "TNF Alpha in Refractory Asthma",
"Official_title" : "The Efficacy of a Soluble Ligand Binding Tumour Necrosis Factor Receptor, Etanercept, in Severe, Steroid Dependant Asthma: a Randomised Controlled Study",
"Conditions" : ["Asthma"],
"Location_Countries" : ["United Kingdom"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional Model" : "CROSSOVER",
"Masking" : "DOUBLE"
}
}
|
#Study Description
Brief Summary
The purpose of this study was to investigate whether the administration of etanercept to patients with severe asthma improved their asthma related quality of life and a measure of the degree of reactivity of the airways
Detailed Description
Although steroid dependent asthma represents a small population of patients with asthma, they consume a disproportionately large amount of the health resource burden attributed to asthma. Treatment options in this group are extremely limited; the development of effective treatments for this group of patients should be a priority, not only for increasing individual patient quality of life but for long term reduction of health spending.
This randomised, double blind, placebo controlled, cross over trial will investigate the efficacy of a soluble TNF receptor, etanercept, in severe, steroid dependant asthma.
#Intervention
- DRUG : Etanercept
|
#Eligibility Criteria:
Inclusion Criteria:
* Symptomatic asthma Methacholine PC20<8mg/ml
Exclusion Criteria:
* History of poor treatment concordance History of tuberculosis Radiographic evidence of previous tuberculosis Recent tuberculosis contact Respiratory tract infection within 3 months Current Smoker or Ex-smoker with more than 5 pack years Symptomatic co-morbid condition Contra-indication to etanercept Pregancy Breast feeding
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT00276029
| 1,308
|
{
"NCT_ID" : "NCT03007979",
"Brief_Title" : "Alternative Dosing Schedule of Palbociclib in Metastatic Hormone Receptor Positive Breast Cancer",
"Official_title" : "A Phase II Clinical Trial Assessing the Safety of an Alternative Dosing Schedule of Palbociclib in Metastatic Hormone Receptor Positive Breast Cancer",
"Conditions" : ["Breast Cancer", "Breast Carcinoma", "Cancer of Breast", "Malignant Tumor of Breast"],
"Interventions" : ["Procedure: Research blood draw", "Drug: Letrozole", "Procedure: Circulating tumor cell blood draw", "Drug: Palbociclib", "Procedure: Tumor biopsy (optional)", "Procedure: Optional research biopsy", "Drug: Goserelin", "Drug: Fulvestrant"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional Model" : "SINGLE_GROUP",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
The investigators propose to conduct a study to test an alternative dosing schedule of palbociclib. With the current three-week on and one week off schedule, a significant number of patients develop grade 3 or higher degree of neutropenia and require dose reduction and sometimes discontinuation. This potentially compromises the efficacy of the drug. In addition, as the half-life of palbociclib is 27 hours, 1 week break with the standard 3 weeks on and 1 week off dosing schedule could potentially lead to recovery of Rb phosphorylation during the off week. Hence, the investigators propose a 5 days on and 2 days off schedule each week without any weeks off drug. Although the cumulative doses each 28-day cycle is roughly the same with this schedule compared to conventional dosing, the bone marrow is not exposed to the drug continuously for 21 days and rather gets frequent breaks from therapy. The investigators hypothesize that the 5 days on and 2 days off schedule is more tolerable with less frequent high grade neutropenia and dose interruption/reduction. In addition, this schedule also provides for a more continuous drug delivery to the patient since there is not a week's break in therapy, which could ultimately prove to be more efficacious.
#Intervention
- DRUG : Palbociclib
- Palbociclib at a dose of 125 mg should be taken by mouth with food on a 5 days on/2 days off schedule
- Other Names :
- Ibrance
- DRUG : Letrozole
- Patients who are receiving letrozole will take it daily by mouth, every day of each 28-day cycle, at a dose of 2.5 mg.
- Other Names :
- Femara
- DRUG : Fulvestrant
- Patients who are receiving fulvestrant will receive it at a dose of 500 mg as two 5 mL intramuscular injections (one into each buttock) on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter.
- Other Names :
- Faslodex
- PROCEDURE : Optional research biopsy
- Patients may consent to paired tumor biopsies at baseline and time of progression.
- DRUG : Goserelin
- Goserelin is given as a subcutaneous injection every 28 days. It is preferred to be given on Day 1 of each cycle, but it may be administered on any day of the treatment cycle to accommodate its specific Q28-day cycle. It will be given to pre- and peri-menopausal women only.
- Other Names :
- Zoladex
- PROCEDURE : Research blood draw
- -Blood will be drawn at the following time points for serum, plasma, cfDNA, and germline DNA (only at baseline):
* Baseline
* C1D15
* C2D1
* Every 2-3 months thereafter (to coincide with imaging studies)
* Time of progression
- PROCEDURE : Circulating tumor cell blood draw
- -Baseline, cycle 2 day 1, post 2 or 3 months of therapy (to coincide with first tumor imaging), and progression
- PROCEDURE : Tumor biopsy (optional)
- -Baseline and progression
|
#Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed metastatic ER+ and/or PR+ and HER2- breast cancer who are candidates for palbociclib in combination with either letrozole or fulvestrant per treating physician.
* Presence of measurable or non-measurable disease by RECIST 1.1 criteria.
* One prior systemic therapy in the metastatic setting is allowed, but patients who have not had any prior systemic therapies in the metastatic setting are also eligible.
*Note: patients who were started on endocrine therapy monotherapy as their 1st line or 2nd line systemic therapy in the metastatic setting for no more than 28 days and without clinical progression prior to the initiation of the study drug therapy are allowed to enroll on the study as their 1st line or 2nd line therapy, respectively.
* At least 18 years.
* Eastern Cooperative Oncology Group (ECOG) performance status <= 2
* Normal bone marrow and organ function as defined below:
* Absolute neutrophil count >= 1,500/mcl
* Platelets >= 100,000/mcl
* Total bilirubin <= institutional upper limit of normal (IULN) or total bilirubin <= 3.0 x IULN with direct bilirubin within normal range in patients with documented Gilbert's syndrome
* AST(SGOT)/ALT(SGPT) <= 1.5 x IULN (up to 5 x IULN in patients with liver disease)
* Creatinine <= IULN OR creatinine clearance >= 60 mL/min/1.73 m2 for patients with serum creatinine levels above institutional normal (calculated by Creatinine Clearance Estimate by Cockcroft-Gault Equation)
* Pre- or post-menopausal women are allowed. If pre- or peri-menopausal, concurrent ovarian suppression for pre- or peri-menopausal women is required.
* Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
* Able to swallow and retain oral medication.
* Washout of at least 3 weeks from prior chemotherapy or targeted therapy that induces myelosuppression and recovery of treatment related adverse events to grade 1 or less, with the exception of alopecia, is required prior to the start of palbociclib.
* Ability to understand and willingness to sign an Institutional Review Board (IRB) approved written informed consent document (or that of legally authorized representative, if applicable).
Exclusion Criteria:
* Prior therapy with any CDK inhibitor.
* Currently receiving any other investigational agents.
* Currently receiving exogenous estrogen replacement (topical vaginal estrogen therapy is allowed).
* Known brain metastases. Patients with known brain metastases must be excluded from this clinical trial because of their poor prognosis which could affect the evaluation of all-cycle adverse events.
* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to palbociclib or other agents used in the study.
* Receiving any medications or substances that are potent inhibitors or inducers of CYP3A isoenzymes within 7 days prior to registration.
* Clinically significant history of liver disease.
* A condition that would interfere with enteric absorption.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
* Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 7 days of study entry.
* Known HIV-positivity on combination antiretroviral therapy because of the potential for pharmacokinetic interactions with palbociclib. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT03007979
| 24,907
|
{
"NCT_ID" : "NCT03030287",
"Brief_Title" : "A Phase 1b Study of OMP-305B83 Plus Paclitaxel in Subjects With Ovarian, Peritoneal or Fallopian Tube Cancer",
"Official_title" : "A Phase 1b Study of OMP-305B83 Plus Weekly Paclitaxel in Subjects With Platinum Resistant Ovarian, Primary Peritoneal or Fallopian Tube Cancer",
"Conditions" : ["Cancer Ovaries", "Cancer Peritoneal", "Cancer, Fallopian Tube"],
"Interventions" : ["Drug: OMP-305B83", "Drug: Paclitaxel"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional Model" : "SINGLE_GROUP",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
The purpose of this study is to test the efficacy and safety of an experimental drug, OMP-305B83, when given in combination with paclitaxel. OMP-305B83 is a humanized monoclonal antibody and was developed to target cancer stem cells. Based on preclinical studies, it is believed that OMP-305B83 may block the growth of cancer stem cells and may also impair the productive growth of new blood vessels, which tumors need to grow and spread.
Detailed Description
This is an open-label, Phase 1b dose escalation and expansion study of OMP-305B83 plus paclitaxel designed to evaluate the safety, efficacy and pharmacokinetics of OMP-305B83 in combination with paclitaxel in patients with platinum resistant ovarian, primary peritoneal or fallopian tube cancer. This study consists of a screening period, a treatment period and a post-treatment follow up period in which patients will be followed for survival for approximately 12 months. Patients will be enrolled in two stages: a dose-escalation stage and an expansion phase.
Approximately 30 patients will be enrolled in this study at approximately 5 study centers in the United States (U.S)..
#Intervention
- DRUG : OMP-305B83
- intravenous (in the vein) infusion
- Other Names :
- bispecific monoclonal antibody
- DRUG : Paclitaxel
- administered intravenously
|
#Eligibility Criteria:
Inclusion Criteria:
* Platinum resistant Grade 2 or 3 ovarian, primary peritoneal or fallopian tube cancer
* Measureable disease per response evaluation criteria (RECIST) v1.1
* Prior bevacizumab
* Age > or = 21 years
* Adequate organ and marrow function
* For women of childbearing potential and men with partners of childbearing potential, agreement (by patient and/or partner) to use two effective forms of contraception from study entry through at least 6 months after the termination visit.
* Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
* Treatment with any anti-cancer therapy, including radiotherapy, chemotherapy, biologic therapy. Prior therapy with weekly paclitaxel for recurrent disease, unless administered more than 2 years prior to enrollment, unless part of an upfront treatment strategy.
* History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, clinical signs or symptoms of gastrointestinaI obstruction or other known clinically signification gastrointestinal disease.
* Subjects with brain metastases
* Subjects with leptomeningial disease or neoplasms in the last 5 years
* Blood pressure >140/80
* Significant intercurrent illness that will limit the patient's ability to participate in the study
* Subjects with known metastases that are currently involving the lumen of the gastrointestinal tract.
* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment, or anticipation of need for major surgical procedure during the course of the study
* Pregnant or nursing women
* New York Heart Association Classification II, III, or IV
* Inability to comply with study and follow up procedure
Sex :
FEMALE
Ages :
- Minimum Age : 21 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT03030287
| 30,593
|
{
"NCT_ID" : "NCT01563991",
"Brief_Title" : "Impact of Perioperative Intravenous Fluid Utilization on Postoperative Outcomes",
"Official_title" : "Impact of Perioperative Intravenous Fluid Utilization on Postoperative Outcomes Following Elective Open Colorectal Surgery",
"Conditions" : ["Benign Neoplasm of Intestinal Tract", "Primary Malignant Neoplasm of Intestinal Tract", "Secondary Malignant Neoplasm of Intestinal Tract"],
"Interventions" : ["Procedure: Normal fluid volume", "Procedure: Reduced fluid volume"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional Model" : "PARALLEL",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
Subjects undergoing surgery on the small or large bowel will be randomized to one of 2 groups, a normal fluid amount group and a reduced fluid amount group to evaluate the impact of this change on recovery after surgery.
Detailed Description
The purpose of this study is to evaluate the impact of reduction in the amount of perioperative fluids on postoperative morbidity, postoperative recovery and the duration of hospitalization. The study will accrue patients undergoing elective open intestinal resection for benign and malignant conditions of the small and large bowel. Patients, who consent to the study, will be randomized at the time of consent, preoperatively. The primary study endpoint will a composite of mortality and major morbidity within the first 30 postoperative days. Secondary endpoints will be return to bowel function (flatus or bowel movement), postoperative hospital stay including the day of surgery and a composite of minor complications. Approximately 186 patients will participate in the study, 93 in each group. Patients will be randomized into one of two groups: the Restricted Fluid Regimen group and the Normal Fluid Administration Regimen group. A very specific flow chart for each group will be followed to distinguish the group. A research nurse will collect the data needed for the study on a daily basis. The patient will be managed by the primary surgeon and his team and the study group flow chart will be followed. If for medical reasons, the patient's care needs to be varied from the study, this is allowed, and will be documented for the study purposes.
#Intervention
- PROCEDURE : Normal fluid volume
- Normal fluid group will receive lactated ringes at 8 cc / Kg/ hr total
- PROCEDURE : Reduced fluid volume
- Subject receives 80 cc/ hr LR during the peri-operative period
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients >= 18 years
* ASA I-III
* Ability to provide informed consent
* Creatinine less than or equal to 1.3 mg/mL)
Exclusion Criteria:
Patients younger than 18 years
* ASA IV or higher
* Urgent or emergent surgery
* Mental disease or addictive disorders impairing ability to provide informed consent
* Renal insufficiency (Cr greater than 1.3 mg/mL)
* Significant language barriers
* Cirrhosis causing ascites
* NYHA III or IV, EF less than 25%
* Use of intraoperative epidural anesthesia
* Uncontrolled diabetes
* Uncontrolled hypertension in the opinion of the enrolling surgeon
* ETOH consumption greater than 35 drinks weekly
* Cachexia or absolute neutrophil count of less than 1,200/mm3
* Existing uncontrolled coagulopathy or platelet count of less than 100,000/mm3
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT01563991
| 5,103
|
{
"NCT_ID" : "NCT03303365",
"Brief_Title" : "Cyberknife Radiosurgery for Patients With Brain Metastases Diagnosed With Either SPACE or MPRAGE Sequence",
"Official_title" : "Cyberknife Radiosurgery for Patients With Brain Metastases Diagnosed With Either SPACE or MPRAGE Sequence - A Prospective Randomized Evaluation of Response and Toxicity",
"Conditions" : ["Brain Metastases", "Adult Solid Tumor"],
"Interventions" : ["Radiation: stereotactic radiosurgery (SRS)"],
"Location_Countries" : ["Germany"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional Model" : "PARALLEL",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
For patients with cerebral oligometastases who are in adequate clinical condition stereotactic radiosurgery (SRS) is the treatment of choice, being recommended by international guidelines for the treatment of one to four lesions. Newer findings have shown that for patients with more than four lesions SRS can be considered as a favorable alternative to whole-brain radiotherapy (WBRT), the currently established standard-of-care treatment. With modern techniques highly conformal SRS of multiple lesions has become feasible with comparable clinical effort and minimal toxicity as compared to WBRT. Developments in magnetic resonance imaging (MRI- imaging) have produced highly sensitive contrast-enhanced three-dimensional fast spin echo sequences such as SPACE that facilitate the detection of very small and early-stage lesions in a fashion superior to the established Magnetization Prepared Rapid Gradient Echo (MPRAGE) series.
Since it has been established that the response of brain metastases to SRS is better for smaller lesions and that WBRT can come at the price of significant neurotoxicity, the investigators hypothesize that 1) earlier detection of small brain metastases and 2) early and aggressive treatment of those by SRS will result in an overall clinical benefit by delaying the failure of repeated localized therapy and thus preserving quality of life and potentially prolonging overall survival. On the other hand however, overtreatment might be a valid concern with this approach since it has yet to be proved that a clinical benefit can be achieved.
The current study aims to stretch the boundaries of the term 'cerebral oligometastases' by performing SRS for up to ten cerebral metastases, compared to the established clinical standard of four, given that existing data supports the non-inferiority of this approach and given that modern Cyberknife SRS facilitates the treatment of multiple lesions with minimal treatment-associated toxicity.
Detailed Description
Scientific Background: Brain metastases are the most common intracranial cancer manifestations, affecting up to one third of adult cancer patients with systemic spread. Prognosis is generally poor with overall survival ranging below 6 months on average. However, a more detailed inspection reveals a prognostic subgroup, for which improved overall survival and clinical symptom control can be achieved and that is most descriptively characterized by favorable clinical performance (KPI ≥ 70%) and extracranially controlled disease. Whereas for most patients with brain metastases whole-brain radiotherapy, steroids or best supportive care represent the palliation treatment of choice, the abovementioned subgroup is eligible to profit from a locally radical therapy concept and in those cases neurosurgical resection and stereotactic radiosurgery have both produced favorable results. In patients unsuitable for neurosurgical resection, single- or multifraction, SRS has several distinct advantages over WBRT, the most significant being short treatment time, less posttherapeutic neurocognitive impairment, better local tumor control and little to no hair loss. Furthermore, SRS can be repeated multiple times or performed before or after WBRT. Current clinical guidelines recommend SRS in cases of cerebral oligometastases, defined as one to four intracranial lesions with an extracranially controlled systemic disease status. However, recent data suggests that it may be a suitable treatment for patients with five to ten or even more than ten lesions, being non-inferior to the SRS of four or less lesions. There are several factors supporting this rationale: On the one hand technical improvements in the field of SRS have significantly facilitated the treatment of a higher number of target lesions with little to no increase in toxicity and comparable clinical effort. On the other hand, the ever improving sensitivity of medical imaging has caused an increase in the detection of oligometastatic constellations, enabling their treatment in an earlier stage. For a long time the contrast-based high-resolution cranial computer tomography (cCT) had been the gold standard of detecting cerebral metastases. This was significantly improved by the introduction of magnetic resonance imaging (MRI) with contrast-enhanced T1-weighted sequences. Sensitivity was further improved with the introduction of 3T MRI into clinical routine and the development of high-resolution three-dimensional gradient-echo sequences such as the contrast-based T1-weighted MPRAGE, featuring a slice thickness of 0.9 mm and multiplanar reconstruction, thus enabling the detection of very small sized lesions in the range of one to a few millimeters. However, the use of gradient-echo (GE) techniques to obtain three-dimensional high-spatial-resolution images comes at the cost of inferior contrast enhancement and higher susceptibility to artifacts than is the case with two-dimensional spin-echo (SE) techniques. Recent developments in MRI research have produced another sequence that might prove even superior to MPRAGE in the specific detection of very small and early brain metastases: Sampling perfection with application-optimized contrasts by using different flip angle evolutions (SPACE) is a three-dimensional fast SE sequence that combines high contrast enhancement superior to MPRAGE with a high spatial resolution and multiplanar reconstruction. Kato et al. have found this sequence to be significantly superior to MPRAGE in the detection of contrast enhanced parenchymal lesions, especially if those are \< 5mm in size as is characteristic of small very-early-stage cerebral metastases.
Trial Objectives: It is the purpose of this study to evaluate treatment response and toxicity after SRS of up to ten simultaneous cerebral metastases, treating either all lesions visible in the highly sensitive SPACE MRI sequence or only those visible in the conventional contrast-based MPRAGE sequence. Treatment response is evaluated with respect to the ineligibility for further cerebral SRS at 12 months after initial SRS, defined by simultaneous new occurrence or progression of \> 10 brain metastases (as a surrogate parameter for overall local control), furthermore overall survival and cognitive function and quality of life.
Patients´Selection: A total of n=200 patients will be enrolled into the trial (n=100 per treatment group). All patients fulfilling the inclusion and exclusion criteria will be informed about the study and included into the study if they declare informed consent. Registration for the study must be performed before the start of RT.
Trial Design: The trial will be performed as a single-center two-armed prospective randomized Phase II study. Patients will be randomized into an experimental arm and a control arm. All patients will receive pre-therapeutic MRI imaging as described in (Chapter 6) and imaging will be assessed by a radiologist. For patients in the experimental arm, all available MRI series, including SPACE will be taken into consideration for the definition of treatment target lesions. For patients in the control arm the assessing radiologist will be blinded with respect to the SPACE sequence and for the definition of treatment target lesions primarily contrast-based three-dimensional MPRAGE, complemented by all non-SPACE MRI sequences will be taken into consideration.
#Intervention
- RADIATION : stereotactic radiosurgery (SRS)
- All patients will receive a pre-treatment cranial MRI for diagnostic and treatment planning purposes.
In Arm A, the contrast-based T1-weighted SPACE sequence is utilized for GTV definition. In Arm B, the contrast-based T1-weighted three-dimensional MPRAGE sequence is utilized for GTV definition. In both cases the GTV consists of all contrasted tissue associated with the target lesion and all additional tissue judged by an experienced physician to be part of the suspect target lesion. To the GTV a PTV margin of 1 mm is added by isotropic expansion that can be slightly modified if deemed necessary by the treating physician (e.g. intersection with adjoining OAR).
Dose prescription to the PTV for target lesions will be as follows:
* 20 Gy to the 70%-isodose (lesions \< 2 cm max. diameter)
* 18 Gy to the 70%-isodose (lesions 2 - 3 cm max. diameter)
* 6 x 5 Gy to the conformally surrounding isodose (lesions \> 3 cm max. diameter)
|
#Eligibility Criteria:
Inclusion Criteria:
* radiologically confirmed metastases of the brain with an underlying history of a malignant illness
* between one and ten suspect intracranial lesions, taking into consideration all available series of the pre-therapeutic MRI (performed at Heidelberg University Hospital and including SPACE sequence)
* age >= 18 years
* Karnofsky Performance Score (KPS) >= 70
* for women with childbearing potential, (and men) adequate contraception.
* ability to understand character and individual consequences of the clinical trial
* written informed consent (must be available before enrolment in the trial)
Exclusion Criteria:
* refusal of the patient to take part in the study
* Small-cell lung cancer (SCLC) as primary malignant illness
* More than 10 suspect intracranial lesions in the initial pre-therapeutic MRI imaging (performed at Heidelberg University Hospital and including SPACE sequence)
* metastasis so close to OAR that initial single-session SRS would be impossible due to lacking radiotolerance
* known contraindications against the performing of cranial MRI
* previous radiotherapy of the brain
* Patients who have not yet recovered from acute toxicities of prior therapies
* Pregnant or lactating women
* Participation in another clinical study or observation period of competing trials, respectively
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT03303365
| 2,025
|
{
"NCT_ID" : "NCT01846871",
"Brief_Title" : "Tivozanib for Recurrent Glioblastoma",
"Official_title" : "A Phase II Study of Tivozanib in Recurrent Glioblastoma",
"Conditions" : ["Glioblastoma"],
"Interventions" : ["Drug: Tivozanib"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional Model" : "SINGLE_GROUP",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
This research study is a Phase II clinical trial, which tests the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific cancer. 'Investigational' means that the study drug tivozanib is still being studied. It also means that the FDA has not yet approved tivozanib for your type of cancer.
Tivozanib is an anti-angiogenesis medicine that fights different types of cancer by blocking the blood supply to the tumor, so that the tumor does not receive the nutrients it requires to grow.
In this research study, we are looking to see what effects, good and bad, tivozanib will have on you and your disease.
Detailed Description
If you are willing to participate in this study, you will be asked to undergo some screening tests and procedures that confirm you are eligible. Many of these tests and procedures are likely to be part of regular cancer care and may be done even if it turns out taht you do not take part in the research study. If you have had some of these tests or procedures recently, they may or may not have to be repeated. The screening process may include the following: a medical history, mini-mental status exam, physical exam, performance status, electrocardiogram, blood tests, urine test. If these tests show that you are eligible to participate in the research study, you will begin the study treatment. If you do not meet the eligibility criteria, you will not be able to participate in this research study.
If you take part in this research study, you will be given a study drug-dosing calendar for each treatment cycle. Each treatment cycle lasts 28 days (4 weeks) during which time you will be taking the study drug once daily for 3 weeks and then no study drug for the last week of each cycle. The diary will also include special instructions for taking the study drug.
During all cycles you will have a physical exam and you will be asked questions about your general health and specific questions about any problems that you might be having and any medications you may be taking.
Standard contrast-enhanced (CE) MRI scans will be done prior to all odd-numbered study cycles. Vascular MRI scans will be done prior to start of treatment, Day 1 of treatment and prior to all even-numbered cycles. These studies will be done in the Charlestown Navy Yard.
We would like to keep track of your medical condition for up to 24 months after your last dose of study treatment. We would like to do this by calling you on the telephone once a year to see how you are doing. Keeping in touch with you and checking your condition every year helps us look at the long-term effects of the research study.
#Intervention
- DRUG : Tivozanib
- Other Names :
- AV-951
|
#Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed glioblastoma that has progressed based on imaging or surgery
* Measurable disease
* No more than 3 prior chemotherapy regimens
* Must have recovered from toxicity of prior therapy. An interval of at least 3 months must have elapsed since the completion of the most recent course of radiotherapy; at least 3 weeks since last non-nitrosourea containing chemotherapy regimen or molecularly targeted agent; at least 6 weeks since the completion of a nitrosourea containing chemotherapy regimen
* Life expectancy of at least 12 weeks
* Able to tolerate MRIs
* Willing to use adequate, highly effective contraception measures while on study and for at least 45 days after the last dose of study drug
Exclusion Criteria:
* Pregnant or breastfeeding
* Major surgical procedure or significant traumatic injury within 28 days of starting therapy; or minor surgical procedure within 7 days
* Receiving other study agents
* Prior therapy with an anti-VEGF agent
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to tivozanib
* Receiving any medications or substances that are inhibitors or inducers of CYP450 enzymes
* Significant cardiovascular disease
* Non-healing wound, bone fracture or skin ulcer
* Active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis or other gastrointestinal condition with increased risk of perforation; abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 4 weeks prior to administration of first dose of study drug
* Uncontrolled intercurrent illness
* Significant thromboembolic or vascular disorders within 6 months prior to administration of first dose of study drug
* Significant bleeding disorders within 6 months prior to administration of first dose of study drug
* Currently active second primary malignancy
* HIV positive and on combination antiretroviral therapy
* Inability to swallow capsules, malabsorption syndrome or gastrointestinal disease that severely affects the absorption of study drugs, major resection of the stomach or small bowel, or gastric bypass procedure
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT01846871
| 33,919
|
{
"NCT_ID" : "NCT03222076",
"Brief_Title" : "Nivolumab With or Without Ipilimumab in Treating Patients With Resectable Liver Cancer",
"Official_title" : "An Open-Label Preoperative Pilot Study Evaluating Nivolumab (Anti-PD-1 Antibody) Alone Versus Nivolumab Plus Ipilimumab (Anti-CTLA-4 Antibody) in Patients With Resectable (HCC)",
"Conditions" : ["Hepatocellular Carcinoma", "Resectable Hepatocellular Carcinoma"],
"Interventions" : ["Biological: Nivolumab", "Biological: Ipilimumab"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional Model" : "PARALLEL",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
This phase II trial studies the side effects and how well nivolumab with or with ipilimumab works in treating patients with liver cancer that can be removed by surgery. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Detailed Description
Primary Objective:
--To evaluate the safety and tolerability of therapy with nivolumab alone or nivolumab + ipilimumab in resectable HCC in the context of presurgical therapy.
Note: Note: As of January 8, 2020, 30 patients have been enrolled and 27 patients have been randomized. The PI decided to stop enrollment since the study has reached its target enrollment of 30 patients
Secondary Objectives:
--To assess the efficacy of presurgical nivolumab alone or nivolumab + ipilimumab therapy in HCC by estimating the objective response rate (ORR) and time to progression (TTP) per RECIST 1.1 progression-free survival (PFS).
Exploratory Objectives:
--To assess the immunological/biomarker changes in tumor tissues and peripheral blood in response to nivolumab alone or nivolumab + ipilimumab in HCC therapy (pre- vs post-treatment), and explore any potential association between these biomarker measures and antitumor response and immune-related response criteria (iRC) assessed by MD Anderson Department of Diagnostic Imaging.
#Intervention
- BIOLOGICAL : Ipilimumab
- Given IV
- Other Names :
- Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody, BMS-734016, MDX-010, MDX-CTLA4, Yervoy
- BIOLOGICAL : Nivolumab
- Given IV
- Other Names :
- BMS-936558, MDX-1106, NIVO, ONO-4538, Opdivo
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients must give written informed consent prior to initiation of therapy, in keeping with the policies of the institution. Patients with a history of major psychiatric illness must be judged able to fully understand the investigational nature of the study and the risks associated with the therapy.
Target population
* Patients with histologically confirmed HCC (Documentation of original biopsy for diagnosis is acceptable if tumor tissue is unavailable) or clinical diagnosis by AASLD criteria in cirrhotic subjects is required (presence of arterial hypervascularity with venous washout). For subjects without cirrhosis, histological confirmation is mandatory. The determination of resectability status will ultimately lie in the clinical judgment of the surgical oncologist and medical oncologist involved in the care of the patient.
* Patient must have measurable disease defined as a lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) and measures >= 15 mm with conventional techniques or >= 10 mm with more sensitive techniques such as MRI or spiral CT scan.
* Patient can have had prior treatment for HCC including prior surgery, radiation therapy, local-regional therapy (abalation or arterial directed therapies), and systemic therapy including sorafenib or chemotherapy (but not anti-PD-1 or anti-CTLA-4 therapy)
* ECOG performance status <= 1.
* Within 14 days of the first dose of study drug, patients must have adequate organ and marrow function as defined below:
* Absolute neutrophil count >= 1,500/μL
* Platelets >=100,000/μL
* Hgb > 9.0 g/dL (may be transfused or receive epoetin alfa [e.g., Epogen®] to maintain or exceed this level)
* Total bilirubin <= 1.5 mg/dl
* Serum creatinine <= 1.5 times the upper limit of normal or estimated CrCL >40mL/min.
* AST (SGOT) and/or ALT (SGPT) <= 5 X institutional upper limit of normal Age and Sex
* Men and women >= 18 years
* Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug.
* Women must not be breastfeeding
* WOCBP must agree to follow instructions for method(s) of contraception from the time of enrollment for the duration of treatment with study drug (s) plus 5 half-lives of study drug (s) plus 30 days (duration of ovulatory cycle) for a total of 5 months post treatment completion.
* Men who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug (s) plus 5 half-lives of study drug (s) plus 90 days (duration of sperm turnover) for a total of 7 months post-treatment completion.
* Azoospermic males and WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements. However, WOCBP must still undergo pregnancy testing as described in these sections.
Investigators shall counsel WOCBP and male subjects who are sexually active with WOCBP on the importance of pregnancy prevention and the implications of an unexpected pregnancy Investigators shall advise WOCBP and male subjects who are sexually active with WOCBP on the use of highly effective methods of contraception. Highly effective methods of contraception have a failure rate of < 1% per year when used consistently and correctly.
At a minimum, subjects must agree to the use of two methods of contraception, with one method being highly effective and the other method being either highly effective or less effective as listed below:
HIGHLY EFFECTIVE METHODS OF CONTRACEPTION
* Male condoms with spermicide
* Hormonal methods of contraception including combined oral contraceptive pills, vaginal ring, injectables, implants, and intrauterine devices (IUDs) such as Mirena by WOCBP subject or male subject's WOCBP partner.
* Nonhormonal IUDs, such as ParaGard
* Tubal ligation
* Vasectomy
* Complete Abstinence* *Complete abstinence is defined as complete avoidance of heterosexual intercourse and is an acceptable form of contraception for all study drugs. Abstinence is only acceptable when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (eg, calendar, ovulation, symptothermal, profession of abstinence for entry into a clinical trial, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Subjects who choose complete abstinence are not required to use a second method of contraception, but female subjects must continue to have pregnancy tests. Acceptable alternate methods of highly effective contraception must be discussed in the event that the subject chooses to forego complete abstinence.
LESS EFFECTIVE METHODS OF CONTRACEPTION
* Diaphragm with spermicide
* Cervical cap with spermicide
* Vaginal sponge
* Male Condom without spermicide*
* Progestin only pills by WOCBP subject or male subject's WOCBP partner
* Female Condom* *A male and female condom must not be used together
Exclusion Criteria:
Any of the following criteria will disqualify the patient from participation:
Target Disease Exceptions
* Any other malignancy from which the patient has been disease-free for less than 2 years, except for non-melanoma skin cancer, or in situ carcinoma of any site.
Medical History and Concurrent Disease
* Patients who have organ allografts.
* Patients who have had a major surgical procedure, open biopsy, or significant traumatic injury with poorly healed wound within 6 weeks prior to first dose of study drug; or anticipation of need for major surgical procedure during the course of the study (other than defined by protocol); fine needle aspirations or core biopsies within 7 days prior to first dose of study drug. NOTE: Patients will be allowed to start cycle 1 day 1 therapy after 24 hours from pre-treatment biopsy.
* Autoimmune disease: Patients with a history of inflammatory bowel disease (including crohn's disease and ulcerative colitis) are excluded from this study as are patients with a history of autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., wegener's granulomatosis]).
* Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
* Any underlying medical condition, which in the opinion of the Investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events, such as a condition associated with frequent diarrhea.
* Patients who have had a history of acute diverticulitis, abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, GI obstruction, abdominal carcinomatosis which are known risks factors for bowel perforation, should be excluded from the study.
* Patients who have a primary brain tumor (excluding meningiomas and other benign lesions), any brain metastases, leptomeningeal disease, seizure disorders not controlled with standard medical therapy, or history of stroke within the past year.
* History of serious systemic disease, including myocardial infarction or unstable angina within the last 12 months, history of hypertensive crisis or hypertensive encephalopathy, uncontrolled hypertension (blood pressure of >140/90 mmHg) at the time of enrollment, New York Heart Association (NYHA) Grade II or greater congestive heart failure, unstable symptomatic arrhythmia requiring medication (patients with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia are eligible), significant vascular disease or symptomatic peripheral vascular disease.
* Patients who have history of other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the subject at high risk from treatment complications.
* Patients who are on high dose steroid (e.g. > 10 mg prednisone daily or equivalent) or other more potent immune suppression medications (e.g. infliximab)
* Patients who have had influenza, hepatitis, or other vaccines within a month prior to initiation of study drugs.
* Patients who have clinical history of coagulopathy, bleeding diathesis or thrombosis within the past year.
* Patients who have serious, non-healing wound, ulcer, or bone fracture.
* Pregnancy (positive pregnancy test) or lactation.
* Patients with prior orthotropic liver transplantation.
* Patients with cirrhosis and severe synthetic liver dysfunction (Child Pugh B-C).
Prohibited Therapies and/or Medications
* Patients must not have received prior anticancer therapy with anti-CLTA-4 or anti-PD1 for HCC. Patients receiving any concomitant systemic therapy for HCC are excluded.
* Patients must not be scheduled to receive another experimental drug while on this study.
* Patients who require ongoing anticoagulation will be excluded. Only aspirin will be permitted. Pre and post-surgical prophylactic anti-coagulation treatment is permitted.
* Patients must not require total parenteral nutrition with lipids.
Other Exclusion Criteria:
* Any patients who cannot be compliant with the appointments required in this protocol must not be enrolled in this study.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT03222076
| 4,059
|
{
"NCT_ID" : "NCT02924324",
"Brief_Title" : "Local Injection of Pain Medication to Reduce Pain After Bone Marrow Procedures in Pediatric Neuroblastoma Patients",
"Official_title" : "RePPAIR -Reducing Procedural Pain and Improving Recovery of Quality of Life in Pediatric Neuroblastoma Patients Undergoing Bone Marrow Procedures: A Prospective Randomized Cross-over Clinical Trial",
"Conditions" : ["Neuroblastoma"],
"Interventions" : ["Behavioral: Post-procedural quality of life (QOL)", "Behavioral: Wong-Baker FACES® Pain Rating Scale", "Drug: ropivacaine", "Device: propofol"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional Model" : "CROSSOVER",
"Masking" : "SINGLE"
}
}
|
#Study Description
Brief Summary
The purpose of this study is to identify whether or not the addition of a numbing medicine that is injected directly into the site of the bone marrow procedure can reduce pain and the use of opioid pain medication after bone marrow procedures. The addition of this medicine, called ropivacaine, is the experimental part of this study. This is the first time ropivacaine will be directly injected into the bone marrow site at MSKCC Pediatrics.
#Intervention
- DEVICE : propofol
- DRUG : ropivacaine
- BEHAVIORAL : Wong-Baker FACES® Pain Rating Scale
- Nurses will record patient-reported pain scores.
- BEHAVIORAL : Post-procedural quality of life (QOL)
|
#Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of neuroblastoma as defined by the International Neuroblastoma Risk Group Staging System (INRGSS)22
* 3 - 18 years
* Patient has had prior bone marrow procedures
* English speaking
Exclusion Criteria:
* History of allergy to investigational agent: ropivacaine or other amino amide analgesics
* History of allergy to standard agent: propofol
* Chronic daily opioid requirement
* Lansky/Karnofsky Score < 60
* Inability to comply with protocol requirements including refusal to forego pre-procedural opioid use
* Patient is receiving additional potentially painful interventions (e.g. central line insertion/removal) concurrent with the bone marrow procedure
Sex :
ALL
Ages :
- Minimum Age : 3 Years
- Maximum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT02924324
| 18,588
|
{
"NCT_ID" : "NCT00079339",
"Brief_Title" : "Tipifarnib and Radiation Therapy in Treating Young Patients With Brainstem Glioma",
"Official_title" : "Phase I/II Trial of R115777 and XRT in Pediatric Patients With Newly Diagnosed Non-Disseminated Intrinsic Diffuse Brainstem Gliomas",
"Conditions" : ["Untreated Childhood Brain Stem Glioma"],
"Interventions" : ["Radiation: radiation therapy", "Drug: tipifarnib"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1", "PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional Model" : "SINGLE_GROUP",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Radiation therapy uses high-energy x-rays to damage tumor cells. Tipifarnib may make tumor cells more sensitive to radiation therapy. Combining tipifarnib with radiation therapy may kill more tumor cells. This phase I/II trial is studying the side effects and best dose of tipifarnib to see how well it works when given together with radiation therapy in treating young patients with newly diagnosed brain stem glioma. (Phase I closed to accrual as of 1/19/06)
Detailed Description
PRIMARY OBJECTIVES:
I. To estimate the maximum tolerated dose (MTD) of R115777 administered concurrently with radiation therapy to pediatric patients with non-disseminated, diffuse, intrinsic brainstem gliomas who are not receiving enzyme-inducing anti-convulsant drugs (EIACD).
II. To assess the efficacy of R115777 treatment in combination with radiation therapy for patients with non-disseminated, diffuse, intrinsic pontine gliomas as measured by progression-free survival and survival distributions.
SECONDARY OBJECTIVES:
I. To characterize toxicities associated with R115777 treatment in combination with and post radiation therapy.
II. To characterize radiographic changes in brainstem gliomas treated with radiation and R115777 using MRI, perfusion and diffusion imaging and PET scans.
OUTLINE: This is a phase I (closed to accrual as of 1/19/06), multicenter, dose-escalation study of tipifarnib followed by a phase II safety and efficacy study.
PHASE I: Patients undergo radiotherapy 5 days a week for 6 weeks. Beginning 0-2 days before radiotherapy, patients receive oral tipifarnib twice daily until the completion of radiotherapy. Beginning 2 weeks after the completion of radiotherapy, patients receive oral tipifarnib twice daily in weeks 1-3. Treatment repeats every 4 weeks for up to 24 additional courses (total of 26 courses) in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of tipifarnib during radiotherapy until the maximum tolerated dose is determined. The MTD is defined as the dose level preceding that at which 2 of 6 patients experience dose-limiting toxicity.
PHASE II: Patients undergo radiotherapy and receive tipifarnib at the MTD as in phase I (closed to accrual as of 1/19/06). Treatment continues for up to 24 months (26 courses) in the absence of disease progression or unacceptable toxicity.
FOLLOW-UP:
Phase I: Participants contributing only to the phase I part are followed for 90 days after completion of therapy. Adverse events that have not resolved within 90 days after stopping treatment will be followed until resolution.
Phase II: Participants in the phase I part treated at the MTD or participants in the phase II part are followed until the earliest of death or three years after starting treatment.
PROJECTED ACCRUAL: A total of 3-55 patients (3-18 patients for phase I \[closed to accrual as of 1/19/06\] and a total of 40 patients for phase II \[including 6 patients treated in the dose-finding portion of phase I (closed to accrual as of 1/19/06)\]) will be accrued for this study within 2.3 years.
#Intervention
- RADIATION : radiation therapy
- Undergo radiotherapy
- Other Names :
- irradiation, radiotherapy, therapy, radiation
- DRUG : tipifarnib
- Given orally
- Other Names :
- R115777, Zarnestra
|
#Eligibility Criteria:
Inclusion Criteria:
* Newly diagnosed non-disseminated intrinsic diffuse brainstem glioma
* Karnofsky performance scale (KPS) (for > 16 yrs of age) or Lansky performance score (LPS) (for =< 16 years) => 50 assessed within two weeks prior to registration
* Prior/concurrent therapy:
* Chemo: No prior therapy allowed
* Radiation therapy (XRT): No prior therapy allowed
* Bone Marrow Transplant: None prior
* Anti-convulsants: Patients receiving EIACDs will not be eligible; however, patients may switch from EIACDs to non-EIACDs and must then be on non-EIACDs for a minimum of 7 days prior to registration
* Growth factors: Off all colony forming growth factor(s) > 2 weeks prior to registration (G-CSF, GM-CSF, erythropoietin)
* Absolute neutrophil count >= 1,000/mm^3
* Platelets >= 100,000/mm^3 (transfusion independent)
* Hemoglobin >= 8 gm/dL (transfusion independent)
* Serum creatinine that is less than the upper limit of institutional normal for age or GFR > 70 ml/min/1.73m2
* Bilirubin =< 1.5 time upper limit of normal for age
* SGPT (ALT) and SGOT (AST) < 2.5 times institutional upper limit of normal
* Female patients of childbearing potential must have negative serum or urine pregnancy test; patient must not be pregnant or breast-feeding
* Patients of childbearing or child fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while being treated on this study
* Signed informed consent according to institutional guidelines must be obtained
Exclusion Criteria:
* Patients must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy; patients must not have any disease that will obscure toxicity or dangerously alter drug metabolism
* Patients with disseminated intrinsic diffuse brainstem glioma
* Patients taking enzyme-inducing anticonvulsant drugs
* Patients with known allergy to topical or systemic imidazoles (e.g., clotrimazole, ketoconazole, miconazole, econazole)
* Patients receiving any other anticancer or experimental drug therapy
* Patients with uncontrolled infection
Sex :
ALL
Ages :
- Minimum Age : 3 Years
- Maximum Age : 21 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT00079339
| 10,567
|
{
"NCT_ID" : "NCT00134069",
"Brief_Title" : "Sorafenib, Cetuximab, and Irinotecan in Treating Patients With Advanced or Metastatic Colorectal Cancer",
"Official_title" : "Phase I/II Clinical, Pharmacological, and Biological Study of BAY 43-9006 in Combination With Cetuximab and Irinotecan in Patients With Advanced Colorectal Cancer",
"Conditions" : ["Recurrent Colon Cancer", "Recurrent Rectal Cancer", "Stage III Colon Cancer", "Stage III Rectal Cancer", "Stage IV Colon Cancer", "Stage IV Rectal Cancer"],
"Interventions" : ["Drug: cetuximab", "Drug: irinotecan hydrochloride", "Drug: sorafenib tosylate"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional Model" : "SINGLE_GROUP",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
This phase I/II trial is studying the side effects and best dose of sorafenib when given together with cetuximab and irinotecan and to see how well they work in treating patients with advanced or metastatic colorectal cancer. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Sorafenib and cetuximab may also stop tumor growth by blocking blood flow to the tumor. Drugs used in chemotherapy, such as irinotecan, work in different ways to kill tumor cells, either by killing the cells or by stopping them from dividing. Giving sorafenib together with cetuximab and irinotecan may kill more tumor cells
Detailed Description
OBJECTIVES:
I. Determine the toxicity spectrum and dose-limiting toxic effects of sorafenib when combined with cetuximab and irinotecan in patients with advanced or metastatic colorectal cancer.
II. Determine the recommended phase II dose of sorafenib when combined with cetuximab and irinotecan in these patients.
III. Correlate the clinical activity of this regimen, in terms of radiologic and positron emission tomography (PET) response, with baseline extracellular signal-regulated kinase (ERK) expression as well as Kirsten rat sarcoma (KRAS), BRAF, and other genetic properties of tumors in these patients.
IV. Determine the pharmacokinetics of this regimen in these patients. V. Correlate the pharmacodynamic effects of this regimen with baseline ERK expression as well as KRAS, BRAF, and other genetic properties of tumors in these patients.
VI. Correlate the pharmacodynamic effects of this regimen on mitogen-activated protein kinase (MAPK) status in peripheral blood mononuclear cells and on normal skin and oral mucosa with clinical parameters in these patients.
OUTLINE: This is a phase I dose-escalation study of sorafenib followed by a multicenter phase II study.
PHASE I:
COURSE 1 (56 days): Patients receive oral sorafenib once or twice daily on days 1-56, cetuximab IV over 1-2 hours on days 1, 8,15, 22, 29, 36, 43, and 50, and irinotecan IV over 90 minutes on days 15, 22, 29, and 36.
COURSE 2 AND ALL SUBSEQUENT COURSES (42 days): Patients receive oral sorafenib once or twice daily on days 1-42, cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36, and irinotecan IV over 90 minutes on days 1, 8, 15, and 22. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of sorafenib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.
PHASE II: Patients receive sorafenib at the MTD determined in phase I, cetuximab, and irinotecan as in phase I.
After completion of study treatment, patients are followed at 30 days.
\*NOTE: This trial was intended to be Phase I/II, but the trial never continued to the Phase II portion.
#Intervention
- DRUG : sorafenib tosylate
- Given orally
- Other Names :
- BAY 43-9006, BAY 43-9006 Tosylate Salt, BAY 54-9085, Nexavar, SFN
- DRUG : cetuximab
- Given IV
- Other Names :
- C225, C225 monoclonal antibody, IMC-C225, MOAB C225, monoclonal antibody C225
- DRUG : irinotecan hydrochloride
- Given IV
- Other Names :
- Campto, Camptosar, CPT-11, irinotecan, U-101440E
|
#Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed colorectal cancer (advanced or metastatic disease not amenable to potential curative resection)
* Archival tumor (blocks and/or slides) must be available for patients who decline tumor biopsies
* Tumor must be amenable to sequential biopsies for patients willing to undergo tumor biopsy
* Must have evidence of disease progression after first-line chemotherapy for advanced disease
* Previously irradiated lesions are not considered measurable disease
* Measurable disease, defined as >= 1 unidimensionally measurable target lesion >= 20 mm by conventional techniques OR >= 10 mm by spiral CT scan
* No known brain metastases
* Eastern Cooperative Oncology Group (ECOG) 0 <= age <= 2 OR Karnofsky 60 <= age <= 100%
* Life expectancy of more than 12 weeks
* white blood cell count (WBC) >= 3,000/mm^3
* Bilirubin normal
* Creatinine normal OR creatinine clearance >= 60 mL/min
* No hypertension
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
* Not pregnant or nursing
* Able to swallow oral medication
* Willing to undergo 2 sequential tumor and skin biopsies
* No ongoing or active infection
* No history of allergic reaction attributed to compounds of similar chemical or biologic composition to study drugs
* No psychiatric illness or social situation that would preclude study compliance
* No other uncontrolled illness
* No prior cetuximab
* No concurrent prophylactic filgrastim (G-CSF), sargramostim (GM-CSF) or epoetin alfa
* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
* No other concurrent chemotherapy
* More than 4 weeks since prior radiotherapy and recovered
* No prior sorafenib
* No other prior therapy targeted against MAPK
* More than 14 days since prior and no concurrent administration of the following cytochrome P450 3A4 (CYP3A4) inducers:
* Rifampin
* Rifabutin
* Hypericum perforatum (St. John's wort)
* Phenytoin
* Carbamazepine
* Phenobarbital
* More than 7 days since prior and no concurrent administration of the following CYP3A4 inhibitors:
* Amiodarone
* Clarithromycin
* Diltiazem
* Erythromycin
* Grapefruit juice
* Indinavir
* Saquinavir
* Lopinavir in combination with ritonavir
* Fosamprenavir
* Ritonavir
* Atazanavir
* Nelfinavir
* Itraconazole
* Ketoconazole
* Nefazodone
* No concurrent combination antiretroviral therapy for HIV-positive patients
* No other concurrent investigational agents
* No other concurrent anticancer therapy
* Negative pregnancy test
* Fertile patients must use effective contraception
* Absolute neutrophil count >=1,500/mm^3
* Platelet count >= 100,000/mm^3
* No evidence of bleeding diathesis
* Aspartate aminotransferase (AST) and Alanine Aminotransferase (ALT) <= 2.5 times upper limit of normal
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT00134069
| 15,647
|
{
"NCT_ID" : "NCT04406623",
"Brief_Title" : "Phase 1 Study of SL-172154 (SIRPα-Fc-CD40L) in Subjects With Ovarian Cancer",
"Official_title" : "Phase 1 Dose Escalation Study of the Agonist Redirected Checkpoint, SL-172154 (SIRPα-Fc-CD40L) Administered Intravenously in Subjects With Ovarian Cancer",
"Conditions" : ["Ovarian Cancer", "Fallopian Tube Cancer", "Primary Peritoneal Carcinoma"],
"Interventions" : ["Drug: SL-172154"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional Model" : "SEQUENTIAL",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
This is a Phase 1 first in human, open label, multi-center, dose escalation study to evaluate the safety, tolerability, PK, anti-tumor activity and pharmacodynamic effects of SL-172154 in subjects with ovarian cancer.
Detailed Description
This Phase 1 trial will evaluate the safety, tolerability, pharmacokinetics, anti-tumor and pharmacodynamic effects of SL-172154 and identify the dose and schedule i.e., recommended Phase 2 dose for future development (RP2D). Subjects eligible for enrollment are required to have platinum-ineligible ovarian, fallopian tube, and primary peritoneal cancers. The study design consists of dose escalation cohorts, an optional pharmacodynamic cohort, and an optional dose expansion cohort. In the dose escalation phase of the study, subjects will be enrolled into sequential dose levels. The study may also enroll a pharmacodynamic cohort to obtain additional pharmacodynamic data at one or more dose levels that have completed evaluation for safety without exceeding the maximum tolerated dose (MTD). Subjects enrolled in the pharmacodynamic cohort will not inform dose escalation decisions. A dose expansion cohort may be opened to further characterize safety, tolerability, PK, anti-tumor activity, and pharmacodynamic data to inform the selection of a RP2D.
#Intervention
- DRUG : SL-172154
- The investigational product (IP), SL-172154, is a novel fusion protein consisting of human SIRPα and CD40L (SIRPα -Fc-CD40L) linked via a human Fc.
|
#Eligibility Criteria:
Inclusion Criteria:
Participants are eligible to be included in the study only if all the following criteria apply:
* Subject has voluntarily agreed to participate by giving written informed consent in accordance with ICH/GCP guidelines and applicable local regulations.
* Subject must have a histologically confirmed diagnosis of an unresectable, locally advanced or metastatic ovarian cancer, or primary peritoneal cancer or fallopian tube cancer.
* Subjects must be refractory or intolerant to existing therapy(ies) known to provide clinical benefit for their condition. Subject must have received platinum-based therapies, and should not be eligible for further platinum therapy, or should be intolerant to such therapy. Subjects with HRD positive disease may participate if they have received prior polyadenosine diphosphate ribose polymerase (PARP) inhibitor therapy given alone or with bevacizumab.
* Subjects should not be primary platinum refractory as defined by progressing during or within 1 month of upfront platinum therapy.
* Has measurable disease by RECIST v1.1 using radiologic assessment.
* Subject age is 18 years and older.
* Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
* Has life expectancy of greater than 12 weeks.
* Has adequate organ function.
* Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test within 72 hours of D1 of IP.
* Recovery from prior anti-cancer treatments including surgery, radiotherapy, chemotherapy or any other anti-cancer therapy to baseline or <= Grade 1.
* Willing to consent to mandatory pre-treatment and on-treatment tumor biopsy(ies), unless there is excessive risk as determined by the investigator.
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
* Prior treatment with an anti-CD47 or anti-SIRPα targeting agent or a CD40 agonist.
* Any anti-cancer therapy within the washout period prior to first dose (D1) of SL-172154.
* Concurrent chemotherapy, immunotherapy, biologic or hormonal/hormonal suppression therapy for cancer treatment is prohibited. Concurrent use of hormones for non-cancer related conditions is acceptable.
* Use of corticosteroids or other immunosuppressive medication, current or within 14 days of D1 of SL-172154 treatment.
* Receipt of live attenuated vaccine within 28 days of D1 of IP.
* Active or documented history of autoimmune disease. Exceptions include controlled Type I diabetes, vitiligo, alopecia areata or hypo/hyperthyroidism.
* Hypersensitivity to the active drug substance or to any of the excipients for the agent to be administered or subjects with known hypersensitivity to Chinese hamster ovary cell products.
* Active pneumonitis (i.e. drug-induced, idiopathic pulmonary fibrosis, radiation-induced, etc.).
* Ongoing or active infection (e.g., no systemic antimicrobial therapy for treatment of infection within 5 days of D1 of IP).
* Symptomatic peptic ulcer disease or gastritis, active diverticulitis, other serious gastrointestinal disease associated with diarrhea within 6 months of D1 of IP.
* Clinically significant or uncontrolled cardiac/thromboembolic disease.
* Untreated central nervous system or leptomeningeal metastases.
* Women who are breast feeding.
* Psychiatric illness/social circumstances that would limit compliance with study requirements and substantially increase the risk of AEs or compromised ability to provide written informed consent.
* Another malignancy that requires active therapy and that in the opinion of the investigator and Sponsor would interfere with monitoring of radiologic assessments of response to IP.
* Has undergone allogeneic stem cell transplantation or organ transplantation.
* Known history or positive test for human immunodeficiency virus, or positive test for hepatitis B.
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT04406623
| 21,963
|
{
"NCT_ID" : "NCT00715793",
"Brief_Title" : "Combination of Decitabine and Temozolomide in the Treatment of Patients With Metastatic Melanoma",
"Official_title" : "Phase I/II Trial of the Combination of Decitabine and Temozolomide in the Treatment of Patients With Metastatic Melanoma",
"Conditions" : ["Malignant Melanoma"],
"Interventions" : ["Drug: Decitabine", "Procedure: biopsy", "Drug: Temozolomide"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1", "PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional Model" : "SINGLE_GROUP",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
The combination of TMZ and DAC may effect dual modulation of DNA repair genes resulting in improved clinical response.
Detailed Description
Primary Objectives:
* Phase I: To determine the safety, tolerability, and Phase II recommended dose of the combination of extended schedule TMZ and DAC.
* Phase II: To determine the efficacy, as measured by overall response rate, of the combination of extended schedule TMZ and DAC given at the Phase II recommended dose to patients with metastatic melanoma.
Secondary Objectives:
* To determine pharmacokinetics of the combination of TMZ and DAC in patients with metastatic melanoma.
* To determine, in peripheral blood mononuclear cells (PBMC) and tumor tissue, the pharmacodynamic effects of the combination of TMZ and DAC on promoter methylation and expression of selected genes and correlate these with response.
* To determine the progression-free survival of patients treated with the combination of TMZ and DAC.
#Intervention
- DRUG : Decitabine
- In Part I patients will be treated on a standard '3+3' phase I dose-escalation design starting at 0.075 mg/kg until a decitabine dose level of 0.15 mg/kg is reached, or, in case unacceptable toxicities are observed, at the maximum tolerated dose (Phase II recommended dose). Decitabine will be administered at the specified dose level, intravenously, daily 5 days a week for the first 2 weeks of a 6-week cycle.
- Other Names :
- DTIC
- DRUG : Temozolomide
- Temozolomide is available in 25 mg and 100 mg tablets that will be administered orally; doses will be rounded to the nearest 25 mg. Temozolomide will be administered orally at 75 mg/m2 daily for 4 weeks starting on week 2 of a 6-week cycle.
- Other Names :
- TMZ
- PROCEDURE : biopsy
- Fine needle aspirates (FNA) and/or core biopsies of tumor samples will be obtained from consenting patients with accessible, evaluable disease, on days 1, 8, 15, and 29 of the first cycle and when patients go off study. Biopsies are optional in Phase I and required for all consenting subjects in Phase II.
- Other Names :
- fine needle aspirate, FNA, core biopsy
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients who have non-resectable Stage IIIB or stage IV metastatic melanoma that have progressed despite prior therapies.
* Life expectancy of at least 12 weeks.
* ECOG performance status of 0, 1 and 2.
* >=18 years.
* Patients who have not received any other chemotherapeutic, biological or investigational agent within 28 days of study drug administration.
* First line and active brain metastases (metastatic lesions to the brain that have been adequately treated with surgery and/or appropriate radiation therapy and that have documented stability for >4 weeks or >2 weeks if treated with stereotactic radiosurgery, remain eligible)
Exclusion Criteria:
* Any evidence of renal dysfunction (proteinuria, estimated creatinine clearance from serum creatinine test of <60 ml/min).
* Impaired hepatic function (liver enzymes greater than twice the upper limit of normal or bilirubin > 2.0 except in patients with Gilbert's syndrome).
* Prior treatment with alkylating agents (including TMZ and DTIC).
* Active brain metastases (metastatic lesions to the brain that have been adequately treated with surgery and/or appropriate radiation therapy and that have documented stability for >4 weeks remain eligible).
* Active infections or serious general medical conditions.
* Female patients of child-bearing age who are not on adequate contraception, or are pregnant or breast-feeding.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT00715793
| 34,699
|
{
"NCT_ID" : "NCT00631618",
"Brief_Title" : "Clinical Trial of Sutent to Treat Metastatic Melanoma",
"Official_title" : "A Phase II Trial of Sutent in Metastatic Melanoma Patients With KIT Aberrations.",
"Conditions" : ["Metastatic Melanoma"],
"Interventions" : ["Drug: Sutent (sunitinib)"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional Model" : "SINGLE_GROUP",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
The purpose of this study is to investigate whether an investigational drug called sunitinib malate is safe and effective in treating metastatic melanoma in patients with KIT mutations.
KIT is a gene that 'codes for' (contains the genetic code that the body uses to make) a protein on the surface of cells in your body that is important in cell growth and cell division. The KIT protein seems to play a role in abnormal cell growth seen in acute leukemia, germ cell tumors, gastrointestinal stromal tumors (GIST), and certain melanomas. Melanomas that arise on acral skin (palms, soles, nail beds), mucosal membranes, and chronically sun damaged skin have recently been found to frequently contain mutations or increased copy numbers of the KIT gene. Your tumor tissue has previously been tested and has been found to contain abnormalities in the KIT gene.
Sunitinib malate is drug that has been shown to inhibit the activity of the KIT protein. The FDA approved sunitinib in 2006 for patients with GIST. It has been shown that sunitinib malate works in these patients because of its activity against the KIT protein. The FDA also approved Sunitinib malate in 2006 for the treatment of metastatic kidney cancer, where its effectiveness is probably due to its ability to block a different set of proteins.
Sunitinib malate has not been approved by the FDA for the treatment of metastatic melanoma.
#Intervention
- DRUG : Sutent (sunitinib)
- The initial dose will be 50mg daily taken for 4 consecutive weeks followed by 2-weeks off to comprise a complete cycle of 6 weeks.
- Other Names :
- sunitinib malate
|
#Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed advanced stage III or IV melanoma with primary origin in mucosal, acral-lentiginous, or chronic sun-damaged skin. Advanced disease is defined as locally recurrent disease or metastatic disease not amenable to surgical therapy. Patients may enter tumor-testing phase even if they do not have recurrent disease.
* Aberration of the KIT gene or KIT receptor on in-vitro testing of their tumor tissue.
* Evidence of measurable disease by RECIST criteria [Appendix 2]. Bone lesions, ascites, peritoneal carcinomatosis or miliary lesions, pleural or pericardial effusions, lymphangitis of the skin or lung, cystic lesions, or irradiated lesions are not considered measurable.
* Resolution of all acute toxic effects of prior chemotherapy, immunotherapy, radiotherapy or surgical procedures to NCI CTCAE Version 3.0 grade <=1.
* Adequate organ function
* ECOG performance status 0 or 1.
Exclusion Criteria:
* Major surgery or radiation therapy within 2 weeks of starting the study treatment. Prior palliative radiotherapy to metastatic lesion(s) is permitted, provided there is at least one measurable lesion that has not been irradiated.
* NCI CTCAE Version 3.0 grade 3 hemorrhage within 4 weeks of starting the study treatment.
* Diagnosis of any second malignancy within the last 2 years, except for adequately treated basal cell carcinoma, squamous cell skin cancer, localized prostate cancer, or in situ cervical cancer.
* Active brain metastases, spinal cord compression, or evidence of symptomatic brain or leptomeningeal carcinomatosis on screening CT or MRI scan. Patients who have had central nervous system metastases treated by surgery or radiation therapy and with those CNS metastases considered in control will be eligible, provided measurable disease outside the CNS is present.
* Any of the following within the 2 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism.
* Ongoing cardiac dysrhythmias of NCI CTCAE Version 3.0 grade > 2.
* Prolonged QTc interval on baseline EKG (>450 msec for males or >470 msec for females)
* Uncontrolled hypertension (> 160/100 mm hg despite optimal medical therapy).
* Concurrent treatment on another clinical trial. Supportive care trials or non-treatment trials, e.g., QOL, are allowed.
* Ongoing treatment with therapeutic doses of warfarin (low dose warfarin up to 2 mg po daily for thromboprophylaxis is allowed).
* Pregnant or breastfeeding.
* Life expectancy less than 3 months.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT00631618
| 20,203
|
{
"NCT_ID" : "NCT00644371",
"Brief_Title" : "Allogenic Stem Cell Transplantation (SCT) With Non-myeloablative Conditioning in Patients With Relapse Non-Hodgkin's Lymphoma (NHL)",
"Official_title" : "Allogeneic Transplantation of Haematopoietic Stem Cells Following Non-myeloablative Conditioning With Melphalan, Fludarabine, Thiotepa, Rituximab and Ibritumomab Tiuxetan (Zevalin) in Patients With Aggressive Non-Hodgkin's B-cell Lymphoma",
"Conditions" : ["Non-Hodgkin Lymphoma"],
"Interventions" : ["Drug: Ibritumomab Tiuxetan (Zevalin)"],
"Location_Countries" : ["Spain"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional Model" : "SINGLE_GROUP",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
To evaluate the use of ibritumomab tiuxetan (Zevalin) as part of the non myeloablative conditioning with melphalan, fludarabine and thiotepa in patients submitted to allogeneic transplantation of haematopoietic stem cells from family donor's peripheral blood.
#Intervention
- DRUG : Ibritumomab Tiuxetan (Zevalin)
- Conditioning Regimen
1. Rituximab, 250 mg/m2 on days -21 and -14.
2. Ibritumomab tiuxetan (Zevalin): 0.4 mCi/kg (14.8 MBq/kg). Maximum: 32 mCi on day -14.
Chemotherapy:
* Fludarabine 30 mg/m2/day on days -7, -6, -5, -4 and -3 as a 30-min infusion.
* Melphalan 70 mg/m2/day on days -3 and -2 as a 15-min infusion.
Chemotherapy for relapsing patients after autologous transplantation including melphalan over the last 6 months:
* Thiotepa 5 mg/kg over 4 hours every 12 hours on day -8.
* Fludarabine 30 mg/m2/day on days -7, -6, -5, -4 and -3 as a 30-min infusion.
* Melphalan 70 mg/m2/day on day -2 as a 15-min infusion.
- Other Names :
- Rituximab (Mabthera)
|
#Eligibility Criteria:
Inclusion Criteria:
* Written informed consent
* Histologically confirmed B-cell lymphoma of the following subtypes:
* LBCDL
* Grade 3b follicular lymphoma
* Mantle-cell lymphoma
* Transformed B-cell lymphoma
* Burkitt lymphoma in patients not eligible for a conventional allogeneic transplant
* High-risk B-cell CD20+ lymphoma defined by
* Having attained less than PR after two chemotherapy lines
* Post-transplantation relapse
* Presence of disease detected through a metabolic approach (PET/CT or else CT+PET) either before or after autologous transplantation
* Inability to collect enough stem cells for autologous transplantation
* Stable disease at the time of transplantation
* Age between 18 and 65
* Performance status (ECOG) <= 2
* Normal and suitable pulmonary function (DLCO >= 30%)
* Left ventricular ejection fraction (LVEF) determined by ventriculography or echocardiogram >= 40%
* Normal hepatic and renal function, with creatinine <= 2 mg/dl and Bi <= 1.5 mg/dl, and alkaline phosphatase <= 2.5 x UNL ; AST, ALT <= 2.5 x UNL (<= 5 x UNL if hepatic infiltration)
Exclusion Criteria:
* Prior treatment with radiopharmaceutical agents
* HIV-associated lymphoma
* Presence of human anti-mouse antibodies (HAMA) or anti-chimeric antibodies (HACA)
* Patient's inability to follow the protocol
* Hypersensitivity to 90Y-itritumomab tiuxetan
* Presence of severe pathologies that preclude chemotherapeutic treatment
* Pregnant women or pregnancy risk due to inappropriate contraceptive measures
* Breastfeeding women
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT00644371
| 33,319
|
{
"NCT_ID" : "NCT00587600",
"Brief_Title" : "Biomarkers in Phototherapy of Barrett's Esophagus",
"Official_title" : "Biomarkers in Phototherapy of Barrett's Esophagus",
"Conditions" : ["Barrett's Esophagus", "High Grade Dysplasia"],
"Interventions" : ["Procedure: Photodynamic therapy", "Procedure: radiofrequency ablation of barrett's esophagus"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2", "PHASE3"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional Model" : "PARALLEL",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
This study is being done to find out if Photodynamic Therapy (treatment with a red light and a drug called photofrin) or Radiofrequency ablation works the same for patients who have biomarkers (abnormalities in molecules of cells that may or may not help predict cancer) present in their Barrett's esophagus as for patients who do not have biomarkers.
#Intervention
- PROCEDURE : Photodynamic therapy
- Photofrin 2mg/kg Photoradiation The light dose delivered will be a total of 200 joules per centimeter fiber which has previously been shown to ablate Barrett's mucosa.
- PROCEDURE : radiofrequency ablation of barrett's esophagus
- radiofrequency ablation
|
#Eligibility Criteria:
Inclusion Criteria:
* All patients will have biopsy proven Barrett's esophagus with evidence of specialized intestinal epithelium and dysplasia (either high grade dysplasia or low grade dysplasia) on histology.
* Patients must have endoscopically visible segments of Barrett's esophagus of greater than 1 centimeter in length.
* All patients must be eligible for longterm follow-up as well as tolerate endoscopy, biopsy, and cytology.
* Patients must be willing to travel to Rochester, Minnesota for follow-up
* Patients must have a friend or relative accompany them on visits since sedatives will render them unable to operate a motor vehicle
* If patients are on anticoagulation, they must be able to tolerate reversal of anticoagulation for study biopsies and therapy
* All patients must be able to tolerate proton pump inhibitor therapy. Esomeprazole will be provided but can be changed to another proton pump inhibitor if the patient is intolerant.
* All patients who have histological or cytological evidence of high grade dysplasia will be seen by an experienced thoracic surgeon for consideration of esophagectomy.
Exclusion Criteria:
* Patients who are unable to follow light avoidance instructions
* Patients with a history of prior esophageal surgery or successful fundoplication
* Patients who had prior photodynamic therapy
* Patients with pre-existing strictures in their esophagus
* Patients who have known allergies to porphyrin compounds
* Patients with a prior biopsies of Barrett's esophagus that contain carcinoma
* Patients who require continuous anti-coagulation
* Patients who are pregnant or are capable of pregnancy will be excluded from this study unless they have been on effective birth control measures
* Lactating mothers are excluded from this study as it is unclear whether the photosensitizer sodium porfimer can cross to the feeding infant
* Patients with underlying liver disease are excluded since their metabolism of porphyrin based photosensitizers is uncertain. Evidence of liver disease will be an transaminase elevation of three times normal, a bilirubin increase of twice normal, or an alkaline phosphatase (liver fraction) elevation of twice normal.
* Patients who have underlying medical conditions that are felt to limit their survival to less than one year.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 85 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT00587600
| 30,015
|
{
"NCT_ID" : "NCT02599142",
"Brief_Title" : "Comparing Immobilisation Shells in Cranial Radiotherapy",
"Official_title" : "A Randomised Controlled Trial Comparing the Accuracy and Acceptability of Closed-face and Open-face Thermoplastic Immobilisation Shells in Cranial Radiotherapy",
"Conditions" : ["Brain Metastases", "Bone Metastases", "Brain Tumor, Primary", "Brain Tumor Adult", "Brain Tumor - Metastatic"],
"Interventions" : ["Device: Group A: Closed-face shell", "Device: Group B: Open-face shell"],
"Location_Countries" : ["United Kingdom"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional Model" : "PARALLEL",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
Patients having radiotherapy to their head and neck wear an immobilisation shell to prevent patient movement and improve treatment accuracy. These shells tend to cover the face and have the potential to cause anxiety and distress in patients, particularly if they suffer with claustrophobia or a similar fear. The study will use an 'open-face' shell that does not cover the face and compare this with the investigators' current 'closed-face' shell. The investigators will obtain treatment verification x-ray images to assess the daily set-up errors and compare these between the two shell type, and ask both patients and radiographers of their experiences from using the shells.
Hypothesis: Open-face immobilisation shells offer equivalent accuracy and efficiency of radiotherapy delivery and are better accepted by patients and radiographers as compared to closed-face immobilisation shells for cranial radiotherapy.
Detailed Description
Patients will be randomised into one of two groups, with group A acting as the control group using the investigators' standard 3--point closed--face shell, and group B using the 3--point open--face shell (experimental group). Each procedure is discussed with the patient before commencement. Patients will be positioned into the optimal treatment position and the shell will be fabricated as per manufacturer instructions by pre-treatment radiographers. This is followed by the patient having a planning CT scan of their head while wearing their shell to allows radiographers and doctors to localise and plan the treatment. At the end of this appointment, the patient will be asked to complete the first of three questionnaires regarding their experience of wearing the shell. Radiographers will be asked to complete a questionnaire of their experience of using the shell, and complete timing data for the procedures.
On the first day of treatment, radiographers will discuss the treatment process and side effects of treatment with the patient, and treatment will be delivered under current department protocols using linear accelerators (linacs). During the course of the treatment, radiographers will obtain 5 sets of verification images for the study, and these will be assessed for set-up errors as per current department policy. Where possible, treatment fields will be used to verify patient position to keep radiation doses from verification imaging as low as reasonably practicable (ALARP). Patients will be asked to complete two more questionnaires on their experience, one on their first day and one on their last day of treatment. Radiographers will also complete questionnaires on these days. Timing data will be obtained for all treatment fractions.
The patient's perspective of the planning and treatment processes will be almost identical to that of patients having cranial radiotherapy that are not in the trial. The only differences that will be observed will be the use of an open-face shell (for patients in group B), completion of three questionnaires, and additional verification imaging.
#Intervention
- DEVICE : Group A: Closed-face shell
- As for arm description
- DEVICE : Group B: Open-face shell
- As for arm description
|
#Eligibility Criteria:
Inclusion Criteria:
* patients prescribed cranial radiotherapy using virtually simulated parallel opposed fields with:
* 5 or more fractions of virtually simulated cranial radiotherapy
* treatment for Primary Central Nervous System Lymphoma (PCNSL), prophylactic cranial irradiation (PCI), or primary or secondary cerebral or bony lesions
Exclusion Criteria:
* patients unable to give informed consent
* patients requiring conformal or inverse-planned radiotherapy
* patients requiring stereotactic radiotherapy
* patients who have previously had cranial or head and neck radiotherapy
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT02599142
| 27,942
|
{
"NCT_ID" : "NCT00570232",
"Brief_Title" : "UAB 0718 - Phase II Trial to Assess Target Oral Therapy as Adjuvant Chemoprevention in High-Risk Head and Neck Cancer",
"Official_title" : "Phase II Trial to Assess Target Oral Therapy as Adjuvant Chemoprevention in High-Risk Head and Neck Cancer",
"Conditions" : ["Head and Neck Cancer"],
"Interventions" : ["Drug: Erlotinib"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "PREVENTION",
"Allocation" : "NA",
"Interventional Model" : "SINGLE_GROUP",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
The purpose of this study is to determine whether erlotinib will be effective in controlling cancer that has returned after treatment with salvage surgery and radiation. This study will also determine what effects, good and/or bad, this drug has on the participants.
Detailed Description
An investigator-initiated Phase II clinical trial of the safety and tolerability of erlotinib as an adjuvant therapy after definitive therapy via salvage surgery in head and neck cancer patients.
#Intervention
- DRUG : Erlotinib
- 150 mg per day by mouth for 12 months
- Other Names :
- Tarceva
|
#Eligibility Criteria:
Inclusion Criteria:
* Pathologically confirmed diagnosis of recurrent or second primary squamous cell carcinoma
* Recurrence or second primary of the oral cavity, oropharynx, hypopharynx, or larynx. Recurrent neck metastasis with unknown primary is allowed
* Prior radiation therapy for head and neck cancer
* Disease must be considered surgically resectable or candidate for curative reirradiation
* Adequate diagnostic workup
* Zubrod Performance Status 0 <= age <= 2
* Life expectancy 12 weeks
* Age 19, 9. Adequate laboratory data.
Exclusion Criteria:
* Prior invasive cancers other than head and neck cancer unless disease free for a minimum of 3 years. (Prior non-melanomatous skin cancer and previous carcinoma in situ are permissible)
* Patients who are pregnant or lactating
* Psychological condition that renders the patient unable to understand the informed consent
* Any situation or condition that will interfere with adherence to study activities.
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT00570232
| 28,888
|
{
"NCT_ID" : "NCT02270788",
"Brief_Title" : "Crenolanib in Combination With Sorafenib in Patients With Refractory or Relapsed Hematologic Malignancies",
"Official_title" : "A Phase I Pharmacokinetic, Pharmacodynamic and Feasibility Study of Crenolanib in Combination With Sorafenib in Patients With Refractory or Relapsed Hematologic Malignancies (ARO-008)",
"Conditions" : ["Acute Myeloid Leukemia"],
"Interventions" : ["Drug: Sorafenib", "Drug: Crenolanib", "Drug: methotrexate, hydrocortisone and cytarabine with leucovorin"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional Model" : "SINGLE_GROUP",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
PRIMARY OBJECTIVE:
This is a pilot study to characterize the toxicity profile, to determine the maximum tolerated dose of the combination of crenolanib and sorafenib, and to determine the feasibility of administering these drugs in patients with relapsed or refractory hematologic malignancies, including acute myeloid leukemia (AML), AML with prior myelodysplastic syndrome (MDS), and myeloperoxidase (MPO)-positive mixed phenotype acute leukemia with FLT3-internal tandem duplication (ITD) and tyrosine kinase domain (TKD) mutations.
The study will include two phases:
* The dose-escalation phase will characterize the dose-limiting toxicities (DLTs) and determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of crenolanib when given in combination with sorafenib.
* The dose-expansion cohort will further assess the safety and explore the efficacy of this combination.
Detailed Description
Each course of therapy will be 28 days (±5 days), unless disease progression is seen while on the combination of crenolanib with sorafenib. Patients may receive subsequent courses (up to a total of 365 days) if there is no disease progression or unacceptable toxicity.
In Day 1 of Course 1, crenolanib is given once in the morning followed by characterization of the pharmacokinetic profile over the following 24-hour period. Starting with day 2 of Course 1, crenolanib will be given 3 times per day through day 28. On Days 8 to 28 of Course 1, sorafenib will be given once per day. Inter-patient dose escalation or de-escalation of crenolanib will be performed based on tolerability and toxicity.
Response will be assessed on days 8 and at end of course. If disease progresses prior to day 8, then sorafenib can be given before day 8.
In subsequent courses (up to 365 days), crenolanib and sorafenib are given on days 1 through 28. The treating physician may increase or decrease the sorafenib dose and frequency of administration per the trial's dosing table on the basis of effects and tolerability. If necessary, the crenolanib dose can be decreased per protocol.
Maintenance therapy must start no sooner than 30 days and no later than 120 days after hematopoietic stem cell therapy (HSCT). Single agent crenolanib will start at the last dose tolerated prior to HSCT. Crenolanib maintenance can be given for up to 365 days and additional therapy can be provided after discussion after discussion with the PI, in patients who continue to benefit after 1 year.
#Intervention
- DRUG : Crenolanib
- Day 1 of Course 1: once followed by pharmacokinetic analysis. Days 2-28 of cycle 1: 3 times per day Crenolanib dose will not be adjusted unless the participant experiences side effects.
All subsequent courses: 3 times per day on Days 1-28. At least 50% of participants in each dose level must be ≤ 18 years old.
- Other Names :
- CP-868,596, IND 112201
- DRUG : Sorafenib
- Days 8-28 of course 1: given orally once each day.
All subsequent courses: given orally on days 1-28 once per day
This is a dose-finding study for the use of sorafenib in combination with crenolanib. Different doses will be given to several participants, with the first participants receiving a lower dose than typically used in children as a single agent. If the drug does not cause serious side effects, it will be given to other study participants at a higher dose. If side effects occur, the dose will be lowered.
- Other Names :
- Sorafenib tosylate, BAY-43-9006, Nexavar®
- DRUG : methotrexate, hydrocortisone and cytarabine with leucovorin
- Triple IT therapy includes methotrexate, hydrocortisone and cytarabine with leucovorin rescue given on day 8. All participants will receive one IT chemotherapy on Day 8 of the first cycle. If they do not have leukemia cells in their spinal fluid, they will receive only one IT chemotherapy per cycle. If leukemia cells are present in their spinal fluid, they will receive IT chemotherapy weekly during the course. Triple IT therapy will be repeated on Day 1 of Cycle 2 and with each subsequent cycle in all participants.
- Other Names :
- Triple IT chemotherapy
|
#Eligibility Criteria:
Inclusion Criteria - Initial Enrollment:
* Participant has a relapsed or refractory hematologic malignancy (with any measurable disease) with FLT3-ITD or TKD mutations and one of the following diagnoses:
* Acute myeloid leukemia (AML)
* AML with prior myelodysplastic syndrome (MDS)
* Myeloperoxidase (MPO)-positive mixed phenotype acute leukemia
* Participant's disease has relapsed after, is refractory to induction and/or salvage therapy, or has relapsed after hematopoietic stem cell transplant (HSCT).
* Participant disease tested positive for FLT3-ITD or -TKD within 60-day screening period.
* Participant's age is 1 <= age <= 25, inclusive (St. Jude participants must be aged 1 <= age <= 25, inclusive).
* Karnofsky or Lansky performance score is > 60%. The Lansky performance score should be used for participants < 16 years and the Karnofsky performance score for participants >= 16 years.
* Adequate organ function defined as:
* Bilirubin <=1.5 x upper limit of normal (ULN)
* ALT <= 3 x ULN and AST <= 3 x ULN
* Serum creatinine <=1.5 x ULN
* Participant must have recovered from the acute side effects of all prior anti-cancer therapy, and:
* At least 2 weeks have elapsed since prior systemic cytotoxic chemotherapy (except intrathecal chemotherapy, hydroxyurea, low-dose cytarabine, and/or low dose maintenance therapy such as vincristine, mercaptopurine, methotrexate or glucocorticoids), and
* If the participant received a prior allogeneic HSCT, at least 30 days have elapsed and there is no evidence of clinically significant graft versus host disease requiring treatment and/or have > grade 2 persistent non-hematologic toxicity related to a transplant
Exclusion Criteria - Initial Enrollment:
* Concurrent chemotherapy, or targeted anti-cancer agents, other than hydroxyurea, low-dose cytarabine, intrathecal therapy and/or low dose maintenance therapy such as vincristine, mercaptopurine, methotrexate or glucocorticoids.
* Patient with concurrent severe and/or uncontrolled medical conditions that, in the opinion of the investigator, may impair participation in the study or the evaluation of safety and/or efficacy.
* Known HIV infection or active hepatitis B (defined as hepatitis B surface antigen-positive) or C (defined as hepatitis C antibody-positive).
* Prior crenolanib treatment for a non-leukemic indication.
* Major surgical procedures within 14 days of Day 1 administration of crenolanib.
* Pregnant or lactating (female participant of childbearing potential must have negative serum or urine pregnancy test required within 7 days prior to start of treatment).
* Male or female participant of reproductive potential must agree to use appropriate methods of contraception for the duration of study treatment and for at least 30 days after last dose of protocol treatment
* Inability or unwillingness or research participant or legal guardian/representative to give written informed consent.
Inclusion Criteria - Maintenance Therapy After HSCT:
* Patient must have received crenolanib on this protocol prior to HSCT to continue on to maintenance.
* Patient must be within 30 - 120 days after hematopoietic stem cell transplant (HSCT).
* Response to previous treatment on this protocol: at least resistant disease with clinical benefit or better response.
* Patient is off or on a stable dose of immunosuppressive drugs for management or prophylaxis of graft-versus-host-disease (GVHD) (defined as no escalation of therapy for GVHD) within 14 days prior to starting crenolanib.
* Patient must have recovered from acute side effects of HSCT, defined as having <Grade 2 non-hematological toxicity related to the transplant (exceptions are alopecia and other non-acute toxicities).
* Adequate hematopoietic recovery (ANC >500/mm^3 and platelet count >50,000/mm^3)
* Research participant or legal guardian/representative is able and willing to give written informed consent.
Sex :
ALL
Ages :
- Minimum Age : 1 Year
- Maximum Age : 39 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT02270788
| 33,174
|
{
"NCT_ID" : "NCT00284752",
"Brief_Title" : "Phase II Trial of Abraxane in Front Line Therapy of Hormone Refractory Metastatic Prostate Cancer",
"Official_title" : "Phase II Trial of Abraxane in Front Line Therapy of Hormone Refractory Metastatic Prostate Cancer",
"Conditions" : ["Prostate Cancer"],
"Interventions" : ["Drug: Abraxane"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional Model" : "SINGLE_GROUP",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
Evaluate the efficacy of Abraxane in first line chemotherapy of patients with hormone refractory metastatic prostate cancer, based on prostate specific antigen (PSA) response
Detailed Description
Taxanes are the most widely tested and effective chemotherapy drugs for hormone refractory prostate cancer. Weekly paclitaxel was reported to produce 25-39% PSA responses in first line and up to 33% in second line chemotherapy of patients with prostate cancer in early clinical trials (1, 2). Paclitaxel activity in prostate cancer is schedule dependent, and weekly paclitaxel was reported to produce highest response rates (1, 2). Docetaxel was recently approved by the Food and Drug Administration for treatment of hormone refractory metastatic prostate cancer, since it is the only chemotherapy drug with documented improvement in survival in this group of patients. Docetaxel was associated with 45.8% overall grade 3/4 toxicities and it has to be given with steroid pre-medication. This regimen might be difficult to use in advanced prostate cancer patients that are often elderly and with multiple co-morbid conditions.
ABI-007 \[Abraxane™ (paclitaxel protein-bound particles for injectable suspension) (albumin-bound)\] is the first in its class of biologically interactive albumin-bound forms of chemotherapy (3). This composition provides a novel approach of increasing intra-tumoral concentration of the drug by a receptor-mediated transport process allowing transcytosis across the endothelial cell wall, thereby breaching the blood/tumor interface. This albumin-specific receptor mediated process involves the binding of a specific receptor (gp60) on the endothelial cell wall, resulting in activation of a protein caveolin-1, which initiates an opening in the endothelial wall with formation of a little caves or caveolae, with transport of the albumin-bound chemotherapeutic complex via these caveolae to the underlying tumor interstitium (4). A protein specifically secreted by the tumor (SPARC) binds and entraps the albumin, allowing release of the hydrophobic drug to the tumor cell membrane. ABI-007 is the first biologically interactive albumin-bound chemotherapy agent leveraging this gp-60/caveolin-1/caveolae/Sparc pathway to increase intra-tumoral concentration of the drug and reduce the amount of the toxic chemotherapy in normal tissue.
Preclinical studies comparing Abraxane to paclitaxel demonstrated lower toxicities, with a maximum tolerated dose (MTD) approximately 50% higher for Abraxane (7) compared to paclitaxel (11). At equal doses there was less myelosuppression and improved efficacy than paclitaxel in a xenograft tumor model of human mammary adenocarcinoma. Clinical studies confirmed improved toxicity profile and higher response rates, in metastatic breast cancer, of Abraxane compared to cremophor EL paclitaxel (Taxol) (5, 8). The weekly regimen was shown to be active even in patients with cancers refractory to paclitaxel, docetaxel or when Abraxane was given after both agents (8).
#Intervention
- DRUG : Abraxane
- This is a Phase II single-arm study for first-line chemotherapy of patients with hormone refractory metastatic prostate cancer. Eligible patients will be chemotherapy naive and will receive weekly Abraxane 100mg/m2 IV over 30 minutes. These will be 4-week cycles with patients receiving Abraxane 100 mg/m2 weekly for 3 weeks and one week off for rest. Patients will continue on therapy until disease or PSA
|
#Eligibility Criteria:
Inclusion Criteria:
* Histopathologically or cytologically proven adenocarcinoma of the prostate metastatic to the bones or lymph nodes as documented by bone scan or CT scan with evidence of progression despite standard hormonal management (orchiectomy, GNRH agonist, or GNRH antagonist-hormone refractory). No major organ allowed
* No prior chemotherapy
* For patients who have been on anti-androgen therapy, patients must have progressive disease after anti-androgen withdrawal (6 weeks biclutamide or nilutamide, 4 weeks for flutamide).
* PSA progression is defined as rising PSA.
Exclusion Criteria:
* Active malignancy other than non-melanoma skin cancer within 5 years of enrollment.
* Significant active medical illness which in the opinion of the investigator will preclude treatment.
* Brain metastasis, any non-bone metastasis except lymph node metastasis
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT00284752
| 29,938
|
{
"NCT_ID" : "NCT00369226",
"Brief_Title" : "Bortezomib Plus Tacrolimus and Methotrexate to Prevent Graft Versus Host Disease (GVHD) After Mismatched Allogeneic Non-Myeloablative Blood Stem Cell Transplantation",
"Official_title" : "Phase I/II Trial of Bortezomib (Velcade) in Addition to Tacrolimus and Methotrexate to Prevent Graft Versus Host Disease (GVHD) After Mismatched Allogeneic Non-Myeloablative Peripheral Blood Stem Cell Transplantation",
"Conditions" : ["Hematologic Malignancies"],
"Interventions" : ["Drug: Methotrexate", "Drug: Bortezomib (Velcade)", "Drug: Tacrolimus", "Procedure: blood stem cell transplantation"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1", "PHASE2"],
"Primary_Purpose" : "PREVENTION",
"Allocation" : "NA",
"Interventional Model" : "SINGLE_GROUP",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
The purpose of this study is to determine if Velcade (also known as bortezomib) can help prevent graft versus host disease (GVHD) developing after transplantation. This is done by using a combination of three immune suppressive medications: Velcade, tacrolimus and methotrexate. Stem cell transplantation is one of the options for patients with cancer of the blood or blood forming organs. Recently, allogeneic stem cell transplants have been performed using lower doses of chemotherapy and radiotherapy: non-myeloablative or 'mini' transplants. GVHD is a significant problem that may occur even after 'mini' transplantations. Information from other research studies, suggests that Velcade may help to reduce the risk of developing GVHD when given early after transplantation.
Detailed Description
* In this study we are looking for the highest dose of Velcade that can be given to people safely when given with tacrolimus and methotrexate. Not everyone who participates in the study will receive the same amount of the study drug. The dose the participant will receive depends upon the number of subjects enrolled on the study and how well they have tolerated their doses of the drug.
* Before Transplant: In addition to the chemotherapy drugs, fludarabine and busulfex, for the participants non-myeloablative transplant, they will also start taking tacrolimus orally three days before their transplant.
* After Transplant Medication: Methotrexate; Intravenously on days 1, 3, 6 \& 11 after transplant for a total of 4 doses. Tacrolimus; Continue taking orally once daily. Velcade: Intravenously on days 1, 4 \& 7 after transplant, a total of 3 doses. Filgrastim: Subcutaneous injection daily starting the day after transplant and continuing until the participant blood counts have recovered.
* After Transplant Physical Exams \& Tests: Participants will have physical exams and blood tests every week for 1 month. After 1 month, a none marrow biopsy will be performed to look for evidence of the donor's cells in the participants bone marrow.
* Following the 1 month period of time, participants will be seen every few weeks. Another bone marrow biopsy, as well as blood tests, will be taken 3-4 months after the transplant to review the disease status. At this point, participants will come into the clinic about every 3 months, or as determined by their physician for about one year.
* While the study ends at 12 months after transplant, we would like to keep track of the participants medical condition for the rest of their life.
#Intervention
- DRUG : Bortezomib (Velcade)
- Infusion for a total of 3 doses
- DRUG : Tacrolimus
- Taken until Doctor determines it is not necessary any more
- DRUG : Methotrexate
- Infusion for a total of 4 doses
- PROCEDURE : blood stem cell transplantation
- Allogeneic Non-myeloablative peripheral blood stem cell transplantation
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients with hematologic malignancies including myelodysplastic syndrome (MDS), who are at a high risk of complications after myeloablative transplantation
* Patients have a donor (both related and unrelated) who are mismatched according to protocol criteria
* 18 years or older
* Performance status 0 <= age <= 2
* Life expectancy of > 100 days
* Female subject is either post-menopausal or sterilized or willing to use an acceptable form of birth control
* Male subject agrees to use an acceptable form of birth control
Exclusion Criteria:
* Evidence of HIV infection
* Total bilirubin > 2.0mg/dl that is due to hepatocellular dysfunction
* Aspartate aminotransferase (AST) > 90
* Known active hepatitis B or C
* Serum creatinine > 2.0
* Greater than or equal to Grade 2 peripheral neuropathy within 21 days of enrollment
* Prior allogeneic stem cell transplant
* Patients with myeloproliferative disease (e.g. myelofibrosis, essential thrombocythemia, polycythemia vera, chronic myeloid leukemia)
* Myocardial infarction within 6 months prior to enrollment or has NYHA Class III or IV hear failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
* Hypersensitivity to Velcade, boron or mannitol
* Pregnant or breast feeding
* Patient has received other investigational drugs 14 days before enrollment
* Serious medical or psychiatric illness
* Another active solid tumor malignancy at the time of study entry
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT00369226
| 3,347
|
{
"NCT_ID" : "NCT00822887",
"Brief_Title" : "Dose Escalation Study of Vandetanib With Hypofractionated Stereotactic Radiotherapy in Recurrent Malignant Gliomas",
"Official_title" : "A Phase I Dose Escalation Study of Vandetanib (ZACTIMA, ZD6474) With Hypofractionated Stereotactic Radiotherapy in Patients With Recurrent Malignant Gliomas",
"Conditions" : ["Malignant Gliomas"],
"Interventions" : ["Radiation: Fractionated Stereotactic Radiotherapy", "Drug: Vandetanib"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional Model" : "SINGLE_GROUP",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
The purpose of the study is to find out the highest dose of vandetanib that can be safely given with repeat radiation therapy.
This study drug has been designed to block certain chemical pathways that stimulate tumor to grow. The study drug has been shown to slow the growth of a number of types of cancers.
This will be a dose escalation study. A dose escalation study means that successive groups of patients will receive higher doses of the study drug. There are three dose levels. The dose of the study drug received will depend on the stage the study has reached at the time a patient decides to participate.
In addition to taking the study drug patients will also receive radiation therapy to the brain tumor for 3 days.
Hypothesis The objective of this study is to determine the maximally tolerated dose (MTD) of VANDETANIB given with 36 Gy hypofractionated stereotactic radiotherapy. The MTD will be dose of VANDETANIB at which no patients develop acute grade 5 toxicity and less than 30% of patients develop acute (within 30 days of radiation therapy) or delayed (at least 30 days after radiation completed) dose limiting toxicities.
Detailed Description
Screening Prior to receiving any treatment, tests will be performed to determine overall medical condition. This will include blood tests, questions about medical history, and physical and neurological exams.
MRI scan of the brain, electrocardiogram (ECG) and chest X-ray will be performed as baseline studies if they have not been performed in the last 28 days.
Women of child-bearing potential will also have a serum pregnancy test within 2 days before taking the study drug.
During treatment If all of the study criteria are met and subject is enrolled in the study, you will start taking the study drug at least 7 days before radiation therapy. You will take the study drug once a day by mouth. You should take the study drug at about the same time each day. If you forget to take a dose, take the missed dose as soon as you remember, as long as it is at least 12 hours before the next dose is due. If it is less than 12 hours until the next dose, do not take the dose you have missed. If you throw up within 30 minutes after you take the study drug, you should take another dose, and use medicine to stop or relieve your vomiting per your doctor's instruction. You will continue to take the study drug for a total duration of one year. The study will be stopped if your disease progresses or there is excessive toxicity. Your participation in the study will be for one year. However, we will continue to follow your disease status, general health and possible treatment-related side effects after one year and for as long as possible.
This is a Phase I study. These types of studies usually include a small number of subjects and are often called dose-escalation studies. Subjects in the first dose group will be receiving a small dose of the study drug. If no unacceptable side effects are observed in these subjects, the next group of subjects will receive the next higher dose of study drug. The study drug doses planned are as follows:
Dose Level Drug dose Level 1 100 mg once a day Level 2 200 mg once a day Level 3 300 mg once a day
You will be assigned to one of three levels depending on when you enter the study.
You will also receive radiation therapy. The radiation dose is the same for all patients. Radiation therapy will begin at least 7 days after you begin taking the study drug. The radiation therapy will be once a day for 3 consecutive days. A special plastic mask will be made for you and used to hold your head still during each radiation treatment.
Tests and procedures will be performed throughout your treatment to determine how your cancer is responding and to monitor you for safety purposes. The tests and procedures will be scheduled for you. The following tests and procedures will be performed:
* Physical examination, neurological examination, and ECG, right before, and in the first, second, fourth, eighth and twelfth week of drug treatment; then once every three months.
* Brain MRI and quality of life questionnaires at one month and three month after radiation therapy, then once every three months.
* Chest X-ray as your doctor determines.
Follow-up You will also have follow-up visits with your doctor once a month for the first 6 months, then once every three months. You may also see your doctor anytime as needed.
Duration You will be on this study for up to 12 months.
#Intervention
- DRUG : Vandetanib
- Dose level 1:100 mg qd Dose level 2:200 mg qd Dose level 3:300 mg qd
- Other Names :
- ZD6474, Zactima
- RADIATION : Fractionated Stereotactic Radiotherapy
- All patients will receive 36 Gy of radiation in three fractions, given in three consecutive days.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients with histopathologically confirmed malignant gliomas that recurred after surgical resection and conventional radiation therapy
* Tumor is not located in the eloquent part of the brain and not touching the brainstem, optic chiasm or optic nerve so that these critical structures will not receive full dose of re-irradiation
* Recurrent tumor is not surgically resectable or patient is not medically operable
* Age > 18 years.
* Radiographical evidence of local recurrence on brain MRI, with or without histopathological confirmation.
* Estimated survival of at least 3 months
* Zubrod Performance Scale of 0 <= age <= 2
* Hgb greater than 10 gm/dl, absolute neutrophil count greater than 1500/ul, platelets greater than 100,000/ul, blood urea nitrogen (BUN) less than 25 mg/dl, Bilirubin less than 2.0 mg/dl, serum glutamate pyruvate transaminase (SGPT) or serum glutamate oxaloacetate transaminase (SGOT) less than 2 x normal range
* Less than or equal to 3 recurrent tumors, and combined largest diameter of all tumors less than or equal to 6 cm
* Single recurrent tumor less than or equal to 6 cm in the largest diameter
Exclusion Criteria:
* Prior therapy with any anti-Epidermal growth factor receptor(EGFR) and/or anti-VEGFR therapies
* Recurrent tumor greater than 6 cm in the largest diameter
* Recurrent tumor located in the brainstem.
* Prior radiation therapy to the brain within 2 months.
* Evidence of severe or uncontrolled systemic disease or any concurrent condition (such as severe cognitive impairment)
* pregnant and breast-feeding women will be excluded
* Treated on any other clinical protocols or with a non-approved or investigational drug within 30 days before Day 1 of study treatment.
* Any evidence of clinically active interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded)
* Clinically significant cardiac event
* History of arrhythmia. Atrial fibrillation, controlled on medication is not excluded.
* Previous history of corrected electrocardiogram QT interval (QTc)prolongation as a result from other medication that required discontinuation of that medication.
* Congenital long QT syndrome, or 1st degree relative with unexplained sudden death under 40 years
* Presence of left bundle branch block QTc with Bazett's correction that is unmeasurable, or 480 msec on screening ECG. If a patient has QTc 480 msec on screening ECG, the screen ECG may be repeated twice (at least 24 hours apart). The average QTc from the three screening ECGs must be less than 480 msec in order for the patient to be eligible for the study.
* Concomitant medication that may cause QTc prolongation, induce Torsades de Pointes or induce cytochrome P450 3A4 (CYP3A4) function Hypertension not controlled by medical therapy (systolic blood pressure greater than 160 mm Hg or diastolic blood pressure greater than 100 mm Hg)
* Active diarrhea that may affect the ability of the patient to absorb the VANDETANIB.
* Major surgery within 4 weeks, or incompletely healed surgical incision before starting study therapy
* Clinical and/or radiographic evidence of bleeding in the recurrent brain tumor.
* Patients currently on enzyme inducing anticonvulsants. However, patients are eligible if the enzyme inducing anticonvulsants can be discontinued or switched to non- enzyme inducing anticonvulsants one week before study entry. Non-enzyme inducing anticonvulsants cannot be those which may cause QTc prolongation, induce Torsades de Pointes or induce CYP3A4 function
* Laboratory results:
* Serum bilirubin greater than 1.5 x the upper limit of reference range (ULRR)
* Serum creatinine greater than 1.5 x ULRR or creatinine clearance less than 50 mL/minute (calculated by Cockcroft-Gault formula)
* Potassium, less than 4.0 mmol/L despite supplementation; serum calcium (ionized or adjusted for albumin,) or magnesium out of normal range despite supplementation
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.5 X ULRR
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT00822887
| 30,544
|
{
"NCT_ID" : "NCT06648902",
"Brief_Title" : "Safety and Preliminary Efficacy of Meldonium in Patients with Metastatic Renal Cell Carcinoma and Treatment-associated Fatigue",
"Official_title" : "A Phase 1/2 Study of the Safety and Preliminary Efficacy of Meldonium in Patients with Metastatic Renal Cell Carcinoma and Treatment-associated Fatigue.",
"Conditions" : ["Renal Cell Cancer Metastatic", "Kidney Cancer", "Fatigue Related to Cancer Treatment"],
"Interventions" : ["Drug: meldonium"],
"Location_Countries" : ["Azerbaijan", "Albania", "Russian Federation"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1", "PHASE2"],
"Primary_Purpose" : "SUPPORTIVE_CARE",
"Allocation" : "NON_RANDOMIZED",
"Interventional Model" : "SEQUENTIAL",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
Fatigue is a prevalent adverse event associated with systemic therapy using tyrosine kinase inhibitors (TKIs). Meldonium, a fatty acid oxidation inhibitor, modifies the carnitine pathway, a nutrient critical for fat metabolism. The World Anti-Doping Agency (WADA) classified meldonium as a banned substance due to its documented use by athletes aiming to enhance physical performance. In this study, the safety and preliminary efficacy of meldonium in treatment-related fatigue will be assessed.
Detailed Description
Fatigue is a frequent symptom of cancer and the most common adverse event of treatment with tyrosine kinase inhibitors. For example, in phase 2 randomized study 59% of patients with metastatic renal cell carcinoma experienced any grade fatigue during treatment with the combination of lenvatinib and everolimus. Fourteen percent of patients had grade 3 fatigue or asthenia. Fatigue was also most frequently reported treatment-related adverse event in patients with unresectable hepatocellular carcinoma (30%), and advanced thyroid cancer (60%) treated with lenvatinib. Additionally, fatigue is one of the most common adverse events associated with the administration of checkpoint inhibitors. Frequency of fatigue was 55% in patients with endometrial cancer treated with combination of pembrolizumab and lenvatinib.
Meldonium is a fatty acid oxidation inhibitor, and it is now principally used for heart conditions, such as angina, heart attack, heart failure, and others. The compound works by altering pathways for carnitine, a nutrient involved in fat metabolism. Meldonium received the greatest fame in sport. The World Anti-Doping Agency (WADA) added meldonium to their list of banned substances in 2016 because of evidence of its use by athletes with the intention of enhancing performance. Center for Preventive Doping Research and European Monitoring Center for Emerging Doping Agents showed that mildronate demonstrates an increase in endurance performance of athletes, improved rehabilitation after exercise, protection against stress, and enhanced activations of the central nervous system functions. Based on these data, meldonium can be a possible option in cancer patients with fatigue treated with targeted or imminotargeted therapy. Moreover, the compound could decrease the number of vascular adverse events of TKIs.
#Intervention
- DRUG : meldonium
- 500 mg (Arm A) or 1,000 mg (Arms B and C) orally daily, weeks 1-6
|
#Eligibility Criteria:
Inclusion Criteria:
* metastatic renal cell carcinoma
* measurable disease based on RECIST 1.1 criteria
* systemic therapy with targeted or immunotargeted therapy
* any grade of fatigue associated with targeted or immunotargeted therapy
* ECOG PS <2
* signed informed consent
Exclusion Criteria:
* Any treatment for fatigue
* Uncompensated hypothyroidism
* Anemia
* Pregnant or nursing
* Local and/or systemic infections requiring antibiotics or COVID-19 within 28 days prior to study entry
* Other malignancy
* Brain metastases
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT06648902
| 14,106
|
{
"NCT_ID" : "NCT00614835",
"Brief_Title" : "Adjuvant Docetaxel Plus Gemcitabine in Patients With Completely Resected Leiomyosarcoma (LMS) of the Uterus",
"Official_title" : "A Pilot Study of Adjuvant Docetaxel Plus Gemcitabine in Patients With Completely Resected Leiomyosarcoma (LMS) of the Uterus",
"Conditions" : ["Uterine Leiomyosarcoma", "Uterine Cancer"],
"Interventions" : ["Drug: Docetaxel plus Gemcitabine"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional Model" : "SINGLE_GROUP",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
This is a pilot study of adjuvant therapy for patients with leiomyosarcoma of the uterus that has been completely removed by surgery. 'Adjuvant' therapy means that the tumor (the leiomyosarcoma) has been completely removed by surgery; thus, giving further treatment now is done in hopes of decreasing the chance that the tumor will come back (relapse or recur). The main goal of this study is to show that this series of treatments is safe for patients with your type of tumor.
In this trial you will be getting drugs that have been approved for use in some types of cancer. In this study we wish to see whether the combination of two chemotherapy drugs, docetaxel and gemcitabine can decrease the chance of your tumor, leiomyosarcoma of the uterus, from coming back (relapsing). We will also be looking at the short-term side effects and risks of the drugs given in this combination to patients with leiomyosarcoma that has been completely resected (removed by surgery).
The combination of gemcitabine and docetaxel has been shown to be safe, and it has been shown to decrease the size of leiomyosarcoma tumors in patients with leiomyosarcoma of the uterus that has relapsed, or has continued to grow despite treatment with other chemotherapy drugs.
#Intervention
- DRUG : Docetaxel plus Gemcitabine
- Gemcitabine 900 mg/m2 IV over 90 minutes day 1 Gemcitabine 900 mg/m2 IV over 90 minutes day 8 + Docetaxel 75 mg/m2 IVPB day 8 Dexamethasone 8 mg po bid days 7-9 GCSF 150 ug/m2 (round to nearest vial size: 350 ug or 480 ug) SQ days 9-15 Repeat every 21 days for total of 4 cycles
|
#Eligibility Criteria:
Inclusion Criteria:
* Pathologically confirmed leiomyosarcoma of the uterus, completely resected, stage I, II, III or IV within 8 weeks of surgery to remove the tumor(s). Patients with stage I tumors should have LMS that is considered high-grade by histology.
* No prior chemotherapy for LMS
* No prior treatment with gemcitabine or docetaxel Age > 18 years
* Karnofsky performance status (KPS) > or equal to 80%
* Pre-treatment absolute neutrophil count > or equal to 1500/ul, hemoglobin greater than or equal to 8.0 gm/dl, and platelets > than or equal to 100,000/ul.
* Adequate renal documented by serum creatinine < than or equal to 2.0 mg/dL
* Adequate hepatic function: Total serum bilirubin must be within institutional normal limits; transaminases (ALT and AST) may be up to 2.5 x institutional upper limit of normal (ULN) if alkaline phosphatase is < than or equal to ULN, or alkaline phosphatase may be up to 4 x ULN if transaminases are < than or equal to ULN.
If peripheral neuropathy is present, it must be less than or equal to grade 1
* Capable of providing written, informed consent
* Women with child-bearing potential must have a negative pregnancy test and must consent to using effective contraception while on treatment and for a reasonable period there after.
Exclusion Criteria:
* Active, or uncontrolled infection
* Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded. Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than 3 years prior to registration, and the patient remains free of recurrent or metastatic disease.
* Patients who have received prior chemotherapy for any abdominal or pelvic tumor are excluded. Patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than 3 years prior to registration, and that the patient remains free of recurrent or metastatic disease.
* With the exception of non-melanoma skin cancer and other specific malignancies as noted above, patients with other invasive malignancies who had (or have) any evidence of the other cancer present within the last 3 years or whose previous cancer treatment contraindicates this protocol therapy are excluded.
* Known history of hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80, or history of hypersensitivity reaction to gemcitabine.
* Currently has grade 2, 3 or 4 neuropathy
* Pregnant or lactating women
* Known history of congestive heart failure
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT00614835
| 13,091
|
{
"NCT_ID" : "NCT00357422",
"Brief_Title" : "Comparison Study of Operation and PEIT for Small, Solitary Hepatocellular Carcinoma (HCC)",
"Official_title" : "Prospective Randomized Trial of the Effective Therapy for Small, Solitary HCC Comparing Operation and Percutaneous Ethanol Injection Therapy",
"Conditions" : ["Hepatocellular Carcinoma"],
"Interventions" : ["Procedure: Percutaneous ethanol injection therapy", "Procedure: Operation"],
"Location_Countries" : ["Korea, Republic of"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional Model" : "CROSSOVER",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
The purpose of this study is to choose the preferred treatment modality for solitary, small hepatocellular carcinoma.
Detailed Description
To compare the below things between operation group and percutaneous ethanol injection therapy (PEIT) group:
1. Survival
* 5 year overall survival rate
* Disease free survival rate
2. Recurrence
* Cumulative recurrence rate
#Intervention
- PROCEDURE : Operation
- No drug needed
- Other Names :
- surgery
- PROCEDURE : Percutaneous ethanol injection therapy
- 99% ethanol, 2-4cc per one session, two to three sessions per single procedure for one week
- Other Names :
- PEIT
|
#Eligibility Criteria:
Inclusion Criteria:
* The evidences of hepatitis B virus (HBV)&/or hepatitis C virus (HCV) infection or liver cirrhosis
* Single tumor nodule with Child-Pugh classification A (serum albumin >= 3.2 g/dL)
* The maximal, longest diameter of tumor mass measured by CT finding should be less than 2 cm
* Only for the newly detected HCCs which were not treated before
* It should be compatible with the typical finding of hepatocellular carcinomas (HCCs) radiologically (MD CT or dynamic MRI)
* Without portal hypertension
Exclusion Criteria:
* In case of hepatic vein or portal vein invasion radiologically (CT or MRI)
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT00357422
| 10,818
|
{
"NCT_ID" : "NCT00044863",
"Brief_Title" : "Study of Erbitux (Cetuximab) in Patients With Metastatic Colorectal Carcinoma",
"Official_title" : "A Phase II Multicenter Study of Erbitux (Cetuximab) in Patients With Metastatic Colorectal Carcinoma",
"Conditions" : ["Colorectal Neoplasms", "Metastases, Neoplasm"],
"Interventions" : ["Biological: Erbitux (Cetuximab)"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NON_RANDOMIZED",
"Interventional Model" : "SINGLE_GROUP",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
This is a phase II, multicenter, target enrollment of 250 evaluable patients, open-label study of cetuximab in patients with refractory, metastatic colorectal carcinoma. Based on prior studies, we predict that 70 to 75% of patients will be EGFR-positive. Patients must have documented failure after receiving either at least two chemotherapy regimens for metastatic disease or adjuvant therapy plus one chemotherapy regimen for metastatic disease provided that the patient progressed within 6 months of completing adjuvant therapy. Prior chemotherapy must have included irinotecan, oxaliplatin, and a fluoropyrimidine.
Patients will receive an initial dose of cetuximab, 400 mg/m2, intravenously (i.v.) over 120 minutes, followed by weekly treatment with cetuximab, 250 mg/m2 i.v. over 60 minutes. Patients who experience unacceptable toxicity or who have progressive disease will not receive further cetuximab therapy.
Patients will be evaluated for a tumor response at a minimum of every 6 weeks while on cetuximab therapy. Patients with stable disease or a partial or complete response may continue to receive weekly cetuximab therapy, unless they are dose-delayed or discontinued because of toxicity. Patients who have a partial or complete response must have a confirmatory tumor assessment no less than 4 weeks after the initial evaluation demonstrating a response.
In addition, there is a pharmacokinetic companion protocol which will determine the trough and peak levels of cetuximab in 25 patients enrolled in the study at four to eight centers. A pharmacologic serum sample for the determination of levels of cetuximab will be obtained prior to the initial, fourth and sixth cetuximab infusions and 1 hour following the completion of the initial, fourth and sixth cetuximab infusions in the first course; and prior to and 1 hour post the completion of the first cetuximab infusion of each subsequent course of therapy. A course of therapy is defined as six weekly infusions of cetuximab monotherapy. ImClone will perform the pharmacokinetic analyses.
#Intervention
- BIOLOGICAL : Erbitux (Cetuximab)
- 400 mg/m2 initial dose, 250 mg/m2 weekly
|
#Eligibility Criteria:
Inclusion Criteria:
* Provided signed written informed consent.
* Histologically- or pathologically- confirmed metastatic colorectal carcinoma;
* Documented progressive disease after receiving either:
1. at least two chemotherapy regimens for metastatic disease or
2. adjuvant therapy plus one chemotherapy regimen for metastatic disease provided that the patient progressed within 6 months of completing adjuvant therapy. Progressive disease will be defined as progression while on treatment or within 3 months after receiving the last dose of therapy in a given regimen;
* Prior chemotherapy must have included irinotecan, oxaliplatin, and a fluoropyrimidine;
* Measurable disease as defined in Section 3.3.2;
* Immunohistochemical evidence of EGFr expression. Patients will be considered eligible if their tumors demonstrate any EGFr staining, regardless of the intensity, the cellular localization of the staining, or the percentage of cell staining. Patients who do not have tumor tissue available for EGFr testing will undergo biopsy of accessible tumor;
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1 at study entry;
* Adequate recovery from recent surgery, chemotherapy, and radiation therapy. At least 4 weeks must have elapsed from major surgery, prior chemotherapy, prior treatment with an investigational agent, or prior radiation therapy;
* Accessible for treatment and follow-up. Patients enrolled in this trial must be treated at the participating center;
* Men and woman age >= 18 years
Source documentation of the prior treatment (e.g., hospital/clinic records, radiographic reports) must be available to ImClone for review.
Exclusion Criteria:
Sex and Reproductive Status Exceptions
* Women of child bearing potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the study.
* Women who are pregnant or breastfeeding.
* Women with a positive pregnancy test on enrollment or prior to cetuximab administration.
* Sexually active fertile men not using effective birth control.
Medical History and Concurrent Diseases
* Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent;
* A serious uncontrolled medical disorder that would impair the ability of the patient to receive protocol therapy;
* A history of uncontrolled angina, arrhythmias, congestive heart failure, or left ventricular ejection fraction (LVEF) below the institutional range of normal on a baseline multiple gated acquisition (MUGA) scan or echocardiogram (ECHO);
* Known brain metastases;
* Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix. Patients with a previous malignancy but without evidence of disease for greater than or equal to 5 years will be allowed to enter the trial;
Physical and Laboratory Test Findings
* Inadequate hematologic function defined by an absolute neutrophil count (ANC) <1,500/mm3, a platelet count <100,000/mm3, and a hemoglobin level <9 g/dL.
* Inadequate hepatic function, defined by a total bilirubin level greater than or equal to 1.5 times the upper limit of normal (ULN) and aspartate transaminase (AST) and alanine transaminase (ALT) levels greater than or equal to 5 times the ULN.
* Inadequate renal function defined by a serum creatinine level >1.5 times the ULN.
Prohibited Therapies and/or Medications
* A history of cetuximab or other therapy that targeted the EGF receptor;
* A history of prior anti-cancer murine monoclonal antibody therapy;
* Prisoners or patients who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (eg, infectious disease) illness.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT00044863
| 13,116
|
{
"NCT_ID" : "NCT03940196",
"Brief_Title" : "Effect of Tumor Treating Fields (TTFields, 200 kHz) Concomitant With Weekly Paclitaxel for the Treatment of Recurrent Ovarian Cancer (ENGOT-ov50 / GOG-3029 / INNOVATE-3)",
"Official_title" : "ENGOT-ov50 / GOG-3029 / INNOVATE-3: Pivotal, Randomized, Open-label Study of Tumor Treating Fields (TTFields, 200kHz) Concomitant With Weekly Paclitaxel for the Treatment of Recurrent Ovarian Cancer",
"Conditions" : ["Ovarian Cancer"],
"Interventions" : ["Device: NovoTTF-100L(O)", "Drug: Paclitaxel"],
"Location_Countries" : ["Canada", "Israel", "Poland", "Austria", "Netherlands", "Belgium", "Hungary", "Italy", "Germany", "United States", "Spain", "Czechia", "Switzerland"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE3"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional Model" : "PARALLEL",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
The study is a prospective, randomized controlled phase III trial aimed to test the efficacy and safety of Tumor Treating Fields (TTFields) concomitant with weekly paclitaxel for the treatment of recurrent ovarian cancer . The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.
Detailed Description
PAST PRE-CLINICAL AND CLINICAL EXPERIENCE:
The effect of the electric fields (TTFields, TTF) has demonstrated significant activity in in vitro and in vivo ovarian carcinoma pre-clinical models both as a single modality treatment and in combination with chemotherapies. TTFields have been demonstrated to act synergistically with taxanes and have been shown to be additive when combined with other chemotherapies. In addition, TTFields have shown to inhibit metastatic spread of malignant melanoma in in vivo experiment.
In a pilot study, 31 patients with recurrent platinum-resistant ovarian carcinoma received paclitaxel together with TTFields (200 kHz) applied to the abdomen/pelvis until disease progression. The combination was well tolerated and the only device-related adverse event was contact dermatitis.
In addition, a phase III trial of Optune® (200 kHz) as monotherapy compared to active chemotherapy in recurrent glioblastoma patients showed TTFields to be equivalent to active chemotherapy in extending survival, associated with minimal toxicity, good quality of life, and activity within the brain (14% response rate). Finally, a phase III trial of Optune® combined with maintenance temozolomide compared to maintenance temozolomide alone has shown that combined therapy led to a significant improvement in both progression free survival and overall survival in patients with newly diagnosed glioblastoma without the addition of high grade toxicity and without decline in quality of life.
DESCRIPTION OF THE TRIAL:
All patients included in this trial are patients with platinum-resistant ovarian carcinoma. In addition, all patients must meet all eligibility criteria.
Eligible patients will be randomly assigned to one of two groups:
1. Patients receive TTFields at 200 kHz to the abdomen and pelvis using the NovoTTF-100L(O) System together with weekly paclitaxel.
2. Patients receive weekly paclitaxel alone.
Patients will be randomized at a 1:1 ratio. Baseline tests will be performed in patients enrolled in both arms. If assigned to the NovoTTF-100L(O) group, the patients will be treated continuously with the device until progression in the abdomen/pelvis. On both arms, patients who have progression outside the abdomen/pelvis will switch to a second line treatment according to local practice.
SCIENTIFIC BACKGROUND:
Electric fields exert forces on electric charges similar to the way a magnet exerts forces on metallic particles within a magnetic field. These forces cause movement and rotation of electrically charged biological building blocks, much like the alignment of metallic particles seen along the lines of force radiating outwards from a magnet.
Electric fields can also cause muscles to twitch and if strong enough may heat tissues. TTFields are alternating electric fields of low intensity. This means that they change their direction repetitively many times a second. Since they change direction very rapidly (200 thousand times a second), they do not cause muscles to twitch, nor do they have any effects on other electrically activated tissues in the body (brain, nerves and heart). Since the intensities of TTFields in the body are very low, they do not cause heating.
The finding made by Novocure was that finely tuned alternating fields of very low intensity, now termed TTFields (Tumor Treating Fields), cause a significant slowing in the growth of cancer cells. Due to the unique geometric shape of cancer cells when they are multiplying, TTFields cause electrically-charged cellular components of these cells to change their location within the dividing cell, disrupting their normal function and ultimately leading to cell death. In addition, cancer cells also contain miniature building blocks which act as tiny motors in moving essential parts of the cells from place to place. TTFields interfere with the normal orientation of these tiny motors related to other cellular components since they are electrically-charged as well. As a result of these two effects, tumor cell division is slowed, results in cellular death or reverses after continuous exposure to TTFields.
Other cells in the body (normal healthy tissues) are affected much less than cancer cells since they multiply at a much slower rate if at all. In addition TTFields can be directed to a certain part of the body, leaving sensitive areas out of their reach. Finally, the frequency of TTFields applied to each type of cancer is specific and may not damage normally dividing cells in healthy tissues.
In conclusion, TTFields could potentially become treatment for ovarian cancer with very few side effects.
#Intervention
- DEVICE : NovoTTF-100L(O)
- Patients receive continuous TTFields treatment using the NovoTTF-100L(O) device. TTFields treatment will consist of wearing four electrically insulated electrode arrays on the abdomen/pelvis. The treatment enables the patient to maintain regular daily routine.
- Other Names :
- TTFields
- DRUG : Paclitaxel
- Paclitaxel 80 mg/m\^2 intravenous infusion will be administered weekly for 8 weeks and then on Days 1, 8 and 15 of each subsequent 28-day cycle.
- Other Names :
- Weekly Paclitaxel, Taxol
|
#Eligibility Criteria:
Inclusion Criteria:
* 18 years and older
* Epithelial histology of ovarian/primary peritoneal or fallopian tube carcinoma at the time of diagnosis
* Life expectancy of >= 12 weeks
* Maximum two prior lines of systemic therapy following diagnosis of platinum-resistance
* Maximum total of 5 prior lines of systemic therapy
* Amenable to receive weekly paclitaxel and able to operate the NovoTTF-100L(O) System
* ECOG 0 <= age <= 1
* Evaluable (measurable or non-measurable) disease in the abdominal/pelvic region per RECIST V1.
* Signed informed consent form for the study protocol
Exclusion Criteria:
* Primary platinum-refractory disease (progression per RECIST V1.1 during or within 1 month after first line therapy), while secondary platinum-refractory disease is allowed
* Prior disease progression on a weekly paclitaxel for recurrent disease
* Brain metastasis or leptomeningeal spread of the tumor
* Albumin level <25 gram/liter (subjects should not receive total parenteral nutrition or albumin within 2 weeks of the test)
* CTCAE V5.0 Grade 3 or higher peripheral neuropathy
* Implantable electrical medical devices
* Known allergies to medical adhesives or hydrogel
* Known immediate or delayed hypersensitivity reaction or idiosyncrasy to paclitaxel or drugs similar or related to paclitaxel, except for cases that were able to undergo desensitization per investigator
* Prior malignancies treated primarily or for recurrence within 2 years prior to inclusion in this study, except for completely resected non-melanomatous skin carcinoma, or successfully treated in situ carcinoma of the skin, breast or cervix of the uterus
* Serious co-morbidities
* Concurrent anti-tumor therapy beyond weekly paclitaxel, excluding hormonal therapy for breast cancer
* Concurrent active treatment in another clinical trial. However prior participation in clinical trials is allowed as well as participation during survival follow-up
* Pregnancy or breast-feeding (female patients with reproductive potential and their partners must accept to use effective contraception throughout the entire study period and for 3 months after the end of treatment). All patients who are capable of becoming pregnant must take a pregnancy test which is negative within 72 hours before beginning treatment. The definition of effective contraception is left up to the decision of the investigator
* Admitted to an institution by administrative or court order
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT03940196
| 13,513
|
{
"NCT_ID" : "NCT02243748",
"Brief_Title" : "Palliative Care Intervention in Improving Symptom Control and Quality of Life in Patients With Stage II-IV Non-small Cell Lung Cancer and Their Family Caregivers",
"Official_title" : "Translation of a Lung Cancer Palliative Care Intervention for Clinical Practice",
"Conditions" : ["Caregiver", "Psychological Impact of Cancer and Its Treatment", "Recurrent Non-small Cell Lung Cancer", "Stage IIA Non-small Cell Lung Cancer", "Stage IIB Non-small Cell Lung Cancer", "Stage IIIA Non-small Cell Lung Cancer", "Stage IIIB Non-small Cell Lung Cancer", "Stage IV Non-small Cell Lung Cancer"],
"Interventions" : ["Other: Palliative Therapy", "Other: quality-of-life assessment", "Other: questionnaire administration"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "SUPPORTIVE_CARE",
"Allocation" : "NON_RANDOMIZED",
"Interventional Model" : "PARALLEL",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
This clinical trial studies a palliative care intervention in improving symptom control and quality of life in patients with stage II-IV non-small cell lung cancer and their family caregivers. Palliative care programs can provide patients and their caregivers with information on how to manage their symptoms, maintain health and well-being, and access supportive care services. An interdisciplinary palliative care model may effectively link lung cancer patients to the appropriate supportive care services in a timely fashion.
Detailed Description
PRIMARY OBJECTIVES:
I. Adapt a Palliative Care Intervention (PCI) tested in a National Cancer Institute (NCI) funded Program Project (P01) for dissemination to other oncology settings.
II. Determine the impact of the PCI on patient outcomes including symptom control, quality of life (QOL), and distress as compared to the usual care group.
III. Determine the impact of the PCI on family caregivers (FCG) outcomes including caregiver burden, caregiver distress, skills preparation and QOL as compared to the usual care group.
IV. Test the effects of the PCI on patient resource utilization as compared to the usual care group.
OUTLINE: Participants are enrolled sequentially to 1 of 2 phases.
PHASE I: Participants receive usual care. This phase will aid in identifying usual care patterns in each site and provide an audit of system utilization as well as finalization of the educational materials for Phase II.
PHASE II: Participants receive individualized palliative care comprised of tailored educational sessions designed for each patient and FCG that have been modified based on patterns observed in Phase I. The first patient teaching session will cover physical and psychological areas and the second will cover social and spiritual areas. These sessions will be completed within 2 weeks of accrual. A third teaching session is held with the FCG alone to give the FCG the opportunity to discuss their perspectives and focus on their needs. Patients will be asked to identify topics they want included and which if any should be omitted which provides for tailoring of the content to the patient's needs and preferences.
In both groups, participants are followed up for 3 months.
#Intervention
- OTHER : Palliative Therapy
- Receive individualized palliative care
- Other Names :
- Comfort Care, Palliative Care, Palliative Treatment, Symptom Management
- OTHER : quality-of-life assessment
- Ancillary studies
- Other Names :
- quality of life assessment
- OTHER : questionnaire administration
- Ancillary studies
|
#Eligibility Criteria:
Inclusion Criteria:
Patient eligibility criteria for entry into the project include:
* Diagnosis of stages II-IV non-small cell lung cancer (NSCLC)
* Undergoing treatment with surgery, chemotherapy, radiation, or combined modalities
* In Phase 2, subjects are also required on accrual to be referred to Palliative Care
FCG eligibility criteria include:
* Designated by the patient as a person closely involved in their care
* Age 18 years and older
All subjects must have the ability to understand and the willingness to sign a written informed consent
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT02243748
| 11,265
|
{
"NCT_ID" : "NCT01706081",
"Brief_Title" : "Acupuncture for Chronic Lymphedema",
"Official_title" : "Acupuncture for Chronic Lymphedema: A Randomized Wait-list Controlled Trial",
"Conditions" : ["Breast Cancer With Chronic Lymphedema"],
"Interventions" : ["Procedure: Wait-list", "Procedure: Acupuncture"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional Model" : "PARALLEL",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
This study is being done because women have arm swelling for more than 6 months despite wrapping and other treatments. This swelling is called lymphedema. It is the back up of lymph system fluid that causes swelling in the arm. The swelling can just happen, but more commonly it is caused when lymph nodes are removed during cancer surgery. It can develop right after breast cancer treatment or weeks, months or even years later. In our preliminary research, the investigators found that more than 1/3 of the 33 patients showed at least a 30% reduction in lymphedema following acupuncture treatment and there were no serious adverse events during the treatment or 6 month followup.
This study will include a larger group of patients. Patients will be assigned to one of two groups, and results of the groups will be compared to see if acupuncture can reduce lymphedema and whether the effect lasts after acupuncture treatment is completed.
#Intervention
- PROCEDURE : Acupuncture
- Each treatment will be 30 minutes in duration. Patients will receive two acupuncture treatments each week for six consecutive weeks. Patients will be advised to continue their standard lymphedema treatments such as exercise or use of compression garments if these were in use prior to clinical trial participation.
- PROCEDURE : Wait-list
- For participants in the wait-list control group, follow-up objective and subjective assessments of lymphedema will be performed after approximately 6 weeks on the wait-list, before onset of acupuncture treatment, following 6 weeks of acupuncture treatment and about 3 months after completion of treatment. BMI will be measured at the same timepoints.
|
#Eligibility Criteria:
Inclusion Criteria:
* Women age >= 18 years
* Lymphedema in an arm as a result of surgery, chemotherapy, and/or radiation therapy for breast cancer per breast surgeon or medical oncologist
* Patients must have received a clinical diagnosis of lymphedema for at least 6 months and no more than 5 years. This timeframe allows ample time for any surgically related non lymphedema swelling to subside by 6 months post-surgery, while a cap of 5 years will capture the broadest range of cases, and has been used as a timeframe in several studies including our pilot study.
* The affected arm must be >2cm larger than the unaffected arm. Differences of 2 cm or more between the affected and unaffected arm are considered by experts to be clinically significant. Each affected arm will be measured in two areas: upper arm and forearm.
The larger of the two measures-upper arm or forearm- will be used for analysis.
* Classified as International Society of Lymphology (ISL) stage II or higher as determined by an MSKCC Certified Lymphedema Therapist (CLT).
Exclusion Criteria:
* Bilateral lymphedema
* Previous acupuncture treatment for lymphedema
* Concurrent diuretic use
* History of primary (congenital) lymphedema
* Pregnant or planning to become pregnant during the course of the study
* Has an implanted electronically charged medical device
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT01706081
| 13,603
|
{
"NCT_ID" : "NCT01378975",
"Brief_Title" : "A Study of Vemurafenib in Metastatic Melanoma Participants With Brain Metastases",
"Official_title" : "An Open-label, Single-arm, Phase II, Multicenter Study, to Evaluate the Efficacy of Vemurafenib in Metastatic Melanoma Patients With Brain Metastases",
"Conditions" : ["Malignant Melanoma"],
"Interventions" : ["Drug: Vemurafenib"],
"Location_Countries" : ["Israel", "Netherlands", "United Kingdom", "Australia", "Italy", "Germany", "United States", "France", "Spain", "Canada"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NON_RANDOMIZED",
"Interventional Model" : "PARALLEL",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
This open-label, single-arm, multicenter study will evaluate the efficacy and safety in participants with metastatic melanoma who developed brain metastases. Participants may or may not have received prior systemic treatment for metastatic melanoma \[except treatment with v-raf murine sarcoma viral oncogene homolog B (BRAF) or mitogen-activated protein kinase (MEK) inhibitors\]. Participants will receive oral doses of 960 mg vemurafenib twice daily until disease progression, unacceptable toxicity or consent withdrawal.
#Intervention
- DRUG : Vemurafenib
- 960 mg oral doses twice daily until disease progression, unacceptable toxicity or consent withdrawal.
|
#Eligibility Criteria:
Inclusion Criteria:
* Adult participants, >= 18 years
* Histologically confirmed metastatic melanoma (Stage IV, American Joint Committee on Cancer) with BRAF V600 mutation (cobas 4800 BRAF V600 Mutation Test)
* Measurable brain metastases, defined as lesions that were accurately measured in at least one dimension (longest diameter to be recorded) as >=0.5 cm in the brain MRI with contrast, treated or untreated
* Participants may or may not have received prior systemic therapy for metastatic melanoma and either a) have received no prior treatment for brain metastases or b) have received prior treatment for brain metastases and have progressed
* Participants may or may not have symptoms related to their brain metastases
* Eastern Cooperative Oncology Group (ECOG) performance status 0 <= age <= 1
* Participants must have recovered from all side effects of their most recent systemic or local treatment for metastatic melanoma
Exclusion Criteria:
* Increasing corticosteroid dose during the 7 days prior to first dose of study drug
* Leptomeningeal involvement in participants with no prior treatment for brain metastases
* Previous malignancy requiring active treatment within the past 2 years, except for treated and controlled basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix
* Concurrent administration of any anticancer therapies other than those administered in the study
* Treatment with any cytotoxic, investigational drug or targeted therapy 4 weeks prior to first dose of study drug. Radiation therapy <=1 week prior to first administration of vemurafenib; and stereotactic radiotherapy <=1 day prior to prior to first administration of vemurafenib
* Prior treatment with BRAF or MEK inhibitors
* Clinically significant cardiovascular disease or event within the 6 months prior to first dose of study drug
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT01378975
| 27,822
|
{
"NCT_ID" : "NCT01491841",
"Brief_Title" : "IIT CTI Bendamustine, Rituximab, Pixantrone in Relapsed/Refractory B Cell Non-Hodgkin's Lymphoma",
"Official_title" : "Phase I/II Study of the Combination of Bendamustine, Rituximab and Pixantrone in Patients With Relapsed/Refractory B Cell Non-Hodgkin's Lymphoma",
"Conditions" : ["Non-Hodgkin's Lymphoma"],
"Interventions" : ["Drug: Pegfilgrastim", "Drug: Bendamustine + Rituximab + Pixantrone"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NON_RANDOMIZED",
"Interventional Model" : "SEQUENTIAL",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
This is a phase I trial of the combination of bendamustine, rituximab and pixantrone in patients with relapsed/refractory B cell non-Hodgkin lymphoma. A standard 3+3 design will be used to determine the maximum tolerated dose (MTD) of the combination. A static dose of bendamustine and rituximab will be used and the dose of pixantrone will be escalated in each cohort. Pixantrone will be dosed on a 21 day cycle at 55mg/m2, 85mg/m2, and 115mg/m2 in sequential cohorts dependent on acceptable toxicity profile at each dose level. MTD will be determined based on DLTs that occur during the first 2 cycles of the drug combination.
Phase II did not proceed as planned due to withdrawal of pixantrone from the US.
Detailed Description
This is a phase I trial utilizing a traditional 3+3 design to evaluate maximum tolerated dose (MTD) and optimal dose schedule of pixantrone in combination with bendamustine (120mg/m2 on day 1 of each 21 day cycle) and rituximab (375mg/m2 on day 1 of each 21 day cycle). No patients will be entered on an escalated dosage level until at least 3 patients have been treated at the previous level and assessed for a dose limiting toxicity. Dose levels will be escalated in cohorts of 3 patients as long as no drug-related DLT occurs in the first 2 cycles. If one patient is observed to suffer a DLT, this cohort will be expanded to include at least 6 patients total. If less than 2 patients in the expanded cohort of 6 patients experience a DLT, dose escalation will resume. If 2 of 6 patients enrolled at the same dose level experience a DLT, the MTD has been exceeded, and the dose escalation will cease. The next lower dose will be considered the MTD. If any patient withdraws from the study prior to completing 2 cycles for reasons other than a DLT then that patient will be replaced in order to determine the MTD.
If dose limiting toxicity is observed at the initial dose level in 2 patients, the MTD has been exceeded and the starting dose level will be reduced to 25mg/m2. If 1 patient experiences a DLT in the -1 dose range, the cohort will be expanded to at least 6 patients. If a second patient experiences a DLT at the -1 dose level, the trial will be closed.
For part 1, those who have a confirmed diagnosis of relapsed/refractory B cell non-Hodgkin's lymphoma of any subtype will be considered eligible for enrollment. Each cycle will be 21 days. Subjects will be assessed for DLTs during the first 2 cycles of study drug. They will be assessed for response after cycle 2. Patients not experiencing a DLT during the first 2 cycles and who have stable disease or better may continue to receive up to 6 cycles of treatment with the triplet combination. If any patient withdraws from the study prior to completing 2 cycles for reasons other than a DLT then that patient will be replaced in order to determine the MTD.
Phase II did not proceed as planned due to withdrawal of pixantrone from the US.
#Intervention
- DRUG : Bendamustine + Rituximab + Pixantrone
- Dose escalation of pixantrone (55mg/m2, 85mg/m2 and 115mg/m2) in combination with static dose bendamustine (120mg/m2 on Day 1 of each 21 day) and rituximab (375mg/m2 on Day 1 of each 21 day cycle).
- Other Names :
- BRP; BuRP
- DRUG : Pegfilgrastim
- 6mg administered on Day 2 of each 21 day cycle
|
#Eligibility Criteria:
Inclusion Criteria:
* Part I: Subjects must have relapsed or refractory B cell NHL;
* Part II: Subjects must have relapsed or refractory aggressive B cell NHL including follicular lymphoma (FL) grade 3, Diffuse Large B Cell Lymphoma (DLBCL), transformed NHL, mantle cell lymphoma (MCL), or other aggressive B cell NHL histology as per the WHO 2008 criteria;
* Refractory disease (defined as persistence of evaluable disease after therapy) or relapsed disease following at least one prior treatment regimen that should include autologous stem cell transplant unless a patient was not eligible or refused prior transplant;
* Age >= 18 years;
* Eastern Cooperative Oncology Group (ECOG) performance status of <=2;
* Subjects must have measurable or evaluable disease based on physical exam and/or radiographs (CT, MRI, PET) or bone marrow involvement;
* Female subject is either post-menopausal or surgically sterilized;
* Laboratory Values:
* Absolute neutrophil count (ANC) >= 1.5 x 10^9/L; lower levels accepted if due to marrow involvement by lymphoma
* Platelets >= 75,000/mcl; lower levels accepted if due to marrow involvement by lymphoma
* Total bilirubin <= 1.5 X institutional upper limit of normal; <= 3.0 ULN accepted in subjects with Gilbert's Syndrome
* AST/ALT <= 1.5 X institutional upper limit of normal. Subjects with known liver involvement by lymphoma: AST/ALT <= 2 X institutional upper limit of normal
* Serum creatinine < 1.5 X institutional upper limit of normal
* Ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
Exclusion Criteria:
* No chemotherapy, radiation, biologics or immunotherapy within 2 weeks prior to registration (6 weeks if last received BCNU or mitomycin C).
* No radioimmunotherapy within 2 months prior to registration.
* Subjects receiving chronic, systemic treatment with corticosteroids equivalent to > 20mg of prednisone per day. Subjects receiving replacement for adrenal insufficiency will be allowed on the study. Topical or inhaled corticosteroids are allowed.
* Subjects with a history of another primary malignancy <= 3 years ago, with the exception of inactive basal, squamous cell carcinoma of the skin or superficial melanoma only requiring excision, prostate cancer with a PSA that has not increased for at least 3 months, carcinoma in situ of the cervix.
* Major surgery <= 4 weeks prior to registration. Minor surgery <= 2 weeks prior to registration. Insertion of a vascular access device is not considered major or minor surgery. Subjects must have recovered from all surgery related toxicities to <= grade 1 or to baseline if subject started with > grade 1 toxicity, not otherwise violating the above inclusion criteria.
* Subjects who have received investigational drugs <= 4 weeks prior to registration.
* Impaired Cardiac Function:
* QTc > 480 on screening ECG.
* Previous history of angina pectoris or acute MI within 6 months
* Congestive heart failure (New York Heart Association functional classification III-IV) or baseline MUGA/ECHO shows estimated LVEF < 45%
* Any history of torsade de pointes, ventricular fibrillation, uncontrolled ventricular tachycardia, or uncontrolled atrial fibrillation.
* Female patients who are pregnant or breastfeeding
* Patients with history of untreated hepatitis B or who are known carriers of hepatitis B will be excluded from this trial. All subjects will be screened prior to study entry.
* Concurrent use of other anti-cancer agents or anti-cancer treatments.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT01491841
| 18,538
|
{
"NCT_ID" : "NCT01176383",
"Brief_Title" : "Impact of a Gene Test for Susceptibility to Lung Cancer in Smokers",
"Official_title" : "A Protocol for an Randomised Controlled Trial of Smoking Cessation Success Rate With or Without a Genetic Test, 'Respiragene', to Assess Lung Cancer Risk - an Exploratory Study",
"Conditions" : ["Smoking Cessation"],
"Interventions" : ["Genetic: Respiragene test and risk score"],
"Location_Countries" : ["United Kingdom"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "PREVENTION",
"Allocation" : "RANDOMIZED",
"Interventional Model" : "PARALLEL",
"Masking" : "SINGLE"
}
}
|
#Study Description
Brief Summary
Professor RP Young (Associate Professor of Medicine and Molecular Medicine, School of Biological Sciences, University of Auckland) and his team have developed a reliable genetic test 'Respiragene' based on 20 single nucleotide polymorphisms that can be used (together with details of personal and family history) to calculate a smoker's lifetime risk of developing lung cancer. The expectation is that whatever the score (estimated lifetime risk will vary from 5% to 50%) the result will counter 'optimism bias' of the smoker and encourage smoking cessation and this assumption is supported by previous research on similar tests and smoking cessation. The investigators plan to recruit two groups of subjects for smoking cessation but only one group will have the Respiragene test. Eight weekly smoking cessation sessions will be carried out at a Surrey primary care medical centre and will follow the usual format for National Health Service smoking cessation clinics using Champix (varenicline), counselling and the carbon monoxide breath meter but with added: evaluation questionnaires, fagerstrom nicotine addiction score, salivary cotinine (metabolite of nicotine) test. The main outcome measures will be estimation of smoking cessation at 4 weeks and six months after the completion of the seven smoking cessation sessions. Successful smoking cessation has to be confirmed by negative salivary cotinine at 4 weeks and six months and questionnaires will be used to estimate the influence of the Respiragene test compared with standard procedures such as counselling and the carbon monoxide breath readings.
Detailed Description
Despite the 5-10% probability of lung cancer in smokers, 50% do not believe they are at significantly increased risk Despite this, over 80% of smokers would like to know their personal risk of lung cancer. RP Young, a clinician at University of Auckland, has show a three way link between biomarkers for COPD, a set of 20 single nucleotide polymorphisms (SNPs) and lung cancer. He has demonstrated a strong correlation between a risk score (derived from family history of cancer, the 20 SNPs \& clinical COPD) and the development of lung cancers whereas healthy smokers (who had not developed lung cancer) matched for age, gender and lifetime smoking habits had a relatively low risk score (n=446 lung cancer subjects, 484 healthy current smokers. The odds ratio for lung cancer risk varied from 0.2-3.2 depending on the genetic risk (p\<0.001). The Auckland lung cancer risk score has a 90% sensitivity for a score of \>4. The validity of 20 SNP gene test has also been confirmed in populations in Barcelona, Spain and Liverpool, United Kingdom. The test has been given the trade name 'Respiragene'.
Small uncontrolled trials of use of Respiragene in smoking cessation clinics in New Zealand and USA show an improvement in smoking cessation at six months after a Respiragene intervention with quit rates of 30-35%. The trial hypothesis is that smokers who have the Respiragene test and a full explanation of their risk score will have a better quit rate at 4 weeks and at six months (after completion of their eight weekly smoking cessation clinic sessions) than controls. Smoking cessation at the six month follow up will bw confirmed by testing for salivary cotinine. Based on data from Young's small trial, we also hypothesise that this uplift of quit rate will be seen for subjects with both high risk scores and average risk scores (there is no low risk category for smokers). These hypotheses are the basis of the primary end points.
The investigators will also be administering the same questionnaire to each subject and control twice, at 4 weeks and six months (after the smoking cessation course) that is primarily designed to evaluate the impact of the Respiragene test in relation to other influences:
* other components of the smoking cessation clinic sessions (salivary cotinine testing, carbon monoxide breath analyser, general clinic help and advice, clinic fact sheets)
* general environmental factors (cost of cigarettes, family pressure, work regulations, doctor's advice)
The results will be analysed using Statistical Package for the Social Sciences (SPSS) Statistics 17.0 computer programme.
#Intervention
- GENETIC : Respiragene test and risk score
- This 12 gene test used with other data (family history, age and spirometry result) to calculate lifetime risk of lung cancer in smokers who do not quit smoking. This intervention is expected to be a motivator to quit.
- Other Names :
- Respiragene test, Lab 21, Cambridge
|
#Eligibility Criteria:
Inclusion Criteria:
* Aged 20 <= age <= 70 years
* Smoking more than 10 cigarettes daily
Exclusion Criteria:
* Aged under 20 years or > 70 years
* Smoking less than 10 cigarettes daily
* History of major depression and other psychiatric conditions, dementias and serious or terminal illness (cancers etc.).
* Patients on warfarin would be excluded due to interactions between warfarin and varenicline as varenicline will be used as the modern treatment of choice for smoking cessation.
Patients who did not wish to have a genetic test would be referred to the practice nurse for smoking cessation.
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
Yes
|
NCT01176383
| 35,109
|
{
"NCT_ID" : "NCT00916877",
"Brief_Title" : "Prophylactic Cranial Irradiation in Patients With HER-2-Positive Metastatic Breast Cancer",
"Official_title" : "Prophylactic Cranial Irradiation in Patients With HER-2-Positive Metastatic Breast Cancer",
"Conditions" : ["Breast Cancer"],
"Location_Countries" : ["Canada"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional Model" : "SINGLE_GROUP",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
Though brain metastases are a risk in all patients with breast cancer, those with HER-2 overexpression are at significantly greater risk. One series estimated a 30% incidence of brain metastases in this population, while another study found an incidence of approximately 40%. Traditional systemic therapies do not cross the blood brain barrier to any significant degree or at all, but radiation treatment can be effective in the treatment of intracranial metastases.
Detailed Description
The rationale for PCI is that the brain is a sanctuary site where cancer cells can remain inaccessible to chemotheraphy and agents such as trastuzumab due to the blood brain barrier, which prevents potentially harmful chemicals such as chemotherapy agents and antibodies such as trastuzumab from reaching the brain. Decreasing the incidence of brain metastasis with acceptable effects on neurocognitive function would be a significant improvement in the care of patients with MBC.
#Intervention
- RADIATION : Prophylactic Cranial Irradiation
- Prophylactic Cranial Irradiation
|
#Eligibility Criteria:
Inclusion Criteria:
* Female with HER2-positive disease
* 18 years or older
* ECOG greater or equal to 2
* Life expectancy greater or equal to 6 months
* Able to complete self administered quality of life evaluations and neurocognitive testing
* Willing and able to comply with study instructions and commit to all clinic visits for the duration of the study
* Women of child-bearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at the baseline visit and must use highly effective birth control during study
* Signed informed consent form
Exclusion Criteria:
* Current malignancy in the brain, as determined by screening MRI/CT done no more then 6 weeks prior to study treatment with PCI
* Chemo or radiation planned during the period when patients will receive study treatment with PCI
* Prior radiotherapy of the brain
* Prior stroke or brain hemorrhage in the 6 months prior to screening
* History of neurological/psychiatric disorders, including psychotic disorders or demential, or any other reason, which may affect neurocognitive assessment
* Inadequate renal function
* Other known previous or concomitant serious illness or medical condition that may interfere with participation in the study
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT00916877
| 39,379
|
{
"NCT_ID" : "NCT00336648",
"Brief_Title" : "Preop Chemoradiation Resectable Pancreas",
"Official_title" : "A Phase II Pilot Study of Preoperative Gemcitabine and Bevacizumab-Based Chemoradiation for Patients With Resectable Adenocarcinoma of the Pancreas",
"Conditions" : ["Pancreatic Neoplasms"],
"Interventions" : ["Drug: Gemcitabine", "Drug: Avastin (Bevacizumab)", "Procedure: Radiation Therapy"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NON_RANDOMIZED",
"Interventional Model" : "SINGLE_GROUP",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
Primary Objective:
1. To assess resectability rate in patients undergoing gemcitabine plus Avastin-based chemoradiation followed by pancreaticoduodenectomy for adenocarcinoma of the pancreas.
Secondary Objectives:
1. To assess disease free survival and overall survival
2. To assess margin resection rate (R0 vs. R1) in these patients
3. To assess patterns of failure
Detailed Description
Gemcitabine is designed to disrupt the growth of the cancer cells, which causes the cancer cells to start to die.
Avastin is designed to prevent or slow down the growth of tumors by its damaging effects on blood vessel growth in tumors.
Before treatment starts, you will have a complete physical exam. Blood (about 2 tablespoons) will be drawn for tests, and a urine test will be performed. Chest x-rays and computed tomography (CT) scans of the abdomen will be done. Women who are able to have children must have a negative blood (1-2 tablespoons) pregnancy test.
If you are found to be eligible to take part in this study, you will receive gemcitabine once a week, Avastin once every 2 weeks, and radiation 5 times a week. Gemcitabine and Avastin will be given on Saturdays, and the radiation will be given Monday through Friday of each week. You will receive this treatment as an outpatient for 6 weeks.
You will receive gemcitabine through a needle in a vein on Days 1, 8, 15, 22, 29, and 36 (+/- 2 days). You will receive Avastin through a needle in a vein every 2 weeks on Days 1, 15, and 29 (+/- 2 days). On the days you receive both drugs, you will receive Avastin over 30-90 minutes and gemcitabine over 40 minutes.
The first dose of Avastin will be given over about 90 minutes. If you do not have a reaction (such as fever/chills), the next dose will be given over about 60 minutes, and if again no reaction occurs, each dose after that will be given over about 30 minutes. If you experience a reaction to the Avastin infusion, you may be given acetaminophen (such as Tylenol) by mouth and/or diphenhydramine (Benadryl) by vein over 30 minutes before each dose to decrease the risk of further reactions.
Radiation will be given Monday through Friday for 5 1/2 weeks. Each day of treatment, you will lie on a treatment table. The radiation therapist will help position your body so that the radiation goes to the right place. A machine will deliver the radiation. It will take about 15-20 minutes to receive the radiation treatment each day.
If any days of radiation are missed, these days will be made up at the end of your treatment (at the end of 28 days) so that you receive the full amount of radiation.
During the study, you will have physical exams weekly while you are receiving chemoradiation, every other week while you are receiving chemotherapy after surgery, and every 4 months during the follow-up period. You will have blood drawn (1-2 tablespoons each time) for routine tests on a weekly basis while you are receiving chemoradiation, every other week while you are taking Avastin after surgery for 3 months, and every 4 months during the follow-up period. The possible development of side effects will be closely monitored and could require extra blood and/or urine samples. You may also have physical exams, blood and urine tests, x-rays, and scans after completing the chemoradiation part of the study, depending upon what is medically needed for evaluation of ongoing therapy.
The overall effect of treatment will be evaluated at least 8 weeks (+/- 2 days) after the completion of chemoradiation. A chest x-ray and CT scans of the chest, abdomen, and pelvis will then be performed, and blood (about 2 tablespoons) will be drawn for routine tests. Some participants will have surgery to remove part of the pancreas, if needed. The reason to wait at least 8 weeks is to allow a safe period of time to pass after the last dose of Avastin to prevent bleeding during surgery. It may also help decrease the risk of postoperative complications, including bleeding and poor wound healing.
This research study allows participants to receive up to 3 infusions of Avastin during the chemoradiation part of the study. If the treatment is shown to benefit you, your doctor may continue to give additional infusions of Avastin every 2 weeks (+/- 2 days) for 3 months after surgery. After the Avastin treatment, you will have a chest x-ray, abdominal CT scan, and blood (about 2 tablespoons) will be drawn for routine tests every 4 months after surgery for 2 years to check the status of the tumor.
This is an investigational study. The study drugs are commercially available and FDA approved, but their use together with radiation is experimental. Avastin is FDA approved for colon and lung cancers but has not been evaluated by the FDA for pancreatic cancer. Gemcitabine is FDA approved for pancreatic cancer. Avastin will be provided free of charge during the study, however the cost of the infusion of the drug will be the responsibility of you and/or your insurance company. The costs of gemcitabine and radiation are considered standard of care, and will be the responsibility of you and/or your insurance company. Up to 31 patients will take part in this study. All will be enrolled at M. D. Anderson.
#Intervention
- DRUG : Avastin (Bevacizumab)
- 10mg/kg by vein (IV) on Days 1, 2, 15 and 29 the adjuvant therapy every two weeks starting approximately 6 weeks after surgery for three months.
- Other Names :
- Anti-VEGF monoclonal antibody, rhuMAb-VEGF
- DRUG : Gemcitabine
- 400 mg/m2 IV once a week on Days 1, 2, 8,15, 22, 29, 36 +/-2 days (Saturdays)
- Other Names :
- Gemcitabine Hydrochloride, Gemzar
- PROCEDURE : Radiation Therapy
- Day 3 +/-2 days (Monday) Start Radiation therapy, Mon -Fri x 28 days; 50.4 Gy prescribed to the 95% isodose at 1.8 Gy/fraction (28 fractions)
- Other Names :
- RT, Radiotherapy
|
#Eligibility Criteria:
Inclusion Criteria:
* Cytologic or histologic proof of adenocarcinoma of the pancreatic head or uncinate process is required prior to treatment. Islet cell tumors are not eligible.
* Patients must be staged with a physical exam, CXR, and contrast-enhanced CT. Only potentially resectable patients are eligible. Potentially resectable defined as: a) no extra pancreatic disease, b) no evidence (on CT) of tumor extension to the celiac axis or SMA, and c) no evidence (CT or angiogram) of occlusion of the SMV or SMPV confluence. Visceral angiography is optional. Laparoscopic staging is not part of the pretreatment evaluation for this study. Laparoscopy may be performed prior to planned laparotomy at surgeon's discretion. Staging needs to be done within 28 days of enrollment.
* Patients cannot have known hepatic or peritoneal metastases detected by ultrasound (US), CT scan, or laparotomy prior to chemoradiation.
* There will be no upper age restriction; patients with Karnofsky performance status greater than 70 are eligible.
* Adequate renal, and bone marrow function: Leukocytes greater than or equal to 3,000/uL; Absolute neutrophil count greater than or equal to 1,500/uL; Platelets greater than or equal to 100,000/U1; Serum creatinine less than or equal to 2.0-mg/dL and urine protein: creatinine ratio less than or equal to 1.0 at screening
* Hepatic function (endoscopic or percutaneous drainage as needed) Total bilirubin less than or equal to 2 X institutional upper limits of normal (ULN); AST (SGOT)/ALT (SGPT) less than or equal to 5 X institutional ULN
* Patients must have no fever or evidence of infection or other coexisting medical condition that would preclude protocol therapy.
* Pregnant women with a positive (blood B-HCG) pregnancy test are excluded from this study; women of childbearing potential (defined as those who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months) must agree to practice adequate contraception and to refrain from breast feeding, as specified in the informed consent.
* Patients must sign a study-specific consent form.
Exclusion Criteria:
* Tumors in the body or tail of the pancreas (to the left of the portal -SMV confluence) are not eligible.
* Patients with uncontrolled hypertension, baseline blood pressure of greater than 150/100 mmHg
* Unstable angina or New York Heart Association (NYHA) Grade II or greater congestive heart failure.
* History of myocardial infarction, stroke, DVT, or pulmonary embolism within 6 months of the study
* Clinically significant peripheral vascular disease.
* Known history of bleeding diathesis coagulopathy. If patient has prior documented PT, INR then INR should be less than 2.0 (patients on anticoagulation for atrial fibrillation, other cardiac disorders, and for remote history of thrombosis are not excluded). Lab results should be within 2 weeks of patient enrollment.
* Known presence of central nervous system or brain metastases.
* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study
* Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to Day 0
* Urine protein: creatinine ratio greater than 1.0 at screening; a 24 hour urine protein should be obtained and the level must be less than 1gm/24 hours in order for the patient to be eligible.
* History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0
* Serious, non-healing wound, ulcer, or bone fracture
* Evidence of duodenal invasion
* Inability to comply with study and/or follow-up procedures
* Patients less than 18 years.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT00336648
| 11,324
|
{
"NCT_ID" : "NCT06632340",
"Brief_Title" : "Effect of Tumor Base Size in Bladder Cancer",
"Official_title" : "Effect of Tumor Base Size on Recurrence and Progression in Non-muscle Invasise Bladder Cancer",
"Conditions" : ["Bladder Cancer"],
"Interventions" : ["Procedure: TUR-BT"],
"Location_Countries" : ["Turkey"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NON_RANDOMIZED",
"Interventional Model" : "PARALLEL",
"Masking" : "SINGLE"
}
}
|
#Study Description
Brief Summary
Investigators aim to investigate the effect of the size of the base of the tumor in contact with the bladder mucosa on recurrence and progression in non-muscle invasive bladder tumors.
Detailed Description
Between March 2021 and September 2023, 130 patients who applied to our clinic with complaints of hematuria, dysuria, and suprapubic pain, and who were diagnosed with bladder tumor by imaging methods and underwent TUR-MT were included in the study. The groups were compared in terms of age, gender, smoking, ASA, comorbidities, BMI and the number of tumors, size, stage as intraoperative and postoperative data. Patients with tumor base size \<2 cm were classified as Group
1, while with tumor base size ≥2 cm were classified as Group 2. Kaplan Meier survival analysis without recurrence and without progression were performed after comparing the groups in terms of recurrence and progression.
#Intervention
- PROCEDURE : TUR-BT
- Transurethral resection of bladder tumor
|
#Eligibility Criteria:
Inclusion Criteria:
* Bladder Tumor
Exclusion Criteria:
* Invasive Bladder Tumor
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 90 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT06632340
| 5,020
|
{
"NCT_ID" : "NCT03701529",
"Brief_Title" : "Effect of Anesthetic Agents on Optic Nerve Sheath Diameter",
"Official_title" : "Effect of Anesthetic Agents (Propofol, Sevoflurane) on Optic Nerve Sheath Diameter(ONSD) in Patients Undergoing Robot-assisted Laparoscopic Gynecology Surgery",
"Conditions" : ["Uterus Myoma", "Uterine Cancer"],
"Interventions" : ["Drug: Propofol", "Drug: Sevoflurane"],
"Location_Countries" : ["Korea, Republic of"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "SUPPORTIVE_CARE",
"Allocation" : "RANDOMIZED",
"Interventional Model" : "PARALLEL",
"Masking" : "SINGLE"
}
}
|
#Study Description
Brief Summary
The present study is to evaluate the effect of anesthetic agents ( propofol , sevoflurane) on intracranial pressure of female patients undergoing laparoscopic-robotic surgery.
Detailed Description
Anesthetic agents (propofol and sevoflurane)have different effect on intracranial pressure. Sevoflurane when used over 0.5 minimum alveolar concentration, dilates intracranial vasculature and increases intracranial pressure. On the other hand, propofol decreases intracranial blood pressure and intracranial pressure is maintained or decreases.
Optic nerve sheath diameter is a feasible diagnostic tool in evaluating intracranial pressure. Female patients undergoing robot-assisted laparoscopic hysterectomy or myomectomy are evaluated.
#Intervention
- DRUG : Sevoflurane
- 1.5-2.5 vol % sevoflurane is used for maintenance of anesthesia.
- Other Names :
- sevoflurane anesthesia
- DRUG : Propofol
- 2-5 mcg/ml of propofol is used for maintenance of anesthesia.
- Other Names :
- propofol anesthesia
|
#Eligibility Criteria:
Inclusion Criteria:
* female patients undergoing robot-assisted laparoscopic hysterectomy or myomectomy
Exclusion Criteria:
* history of brain hemorrhage or brain infarction
* liver disease or end stage renal disease
* glaucoma or any signs of increased intraocular pressure
* combined wtih other types of operation
* patient refusal
* weight less than 40 kg or over 100 kg
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
Yes
|
NCT03701529
| 4,589
|
{
"NCT_ID" : "NCT03952312",
"Brief_Title" : "Oncotool for Cancer Medications",
"Official_title" : "Feasibility of OncoTool to Improve Self-Management and Adherence to Oral Anticancer Medications",
"Conditions" : ["Cancer", "Cancer, Treatment-Related", "Medication Adherence", "Communication", "Tyrosine Kinase Inhibitor"],
"Interventions" : ["Behavioral: Oncotool Intervention (symptom reporting + TKI education)", "Behavioral: Oncotool Control (health information)"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "SUPPORTIVE_CARE",
"Allocation" : "RANDOMIZED",
"Interventional Model" : "PARALLEL",
"Masking" : "SINGLE"
}
}
|
#Study Description
Brief Summary
The purpose of this study is to examine the efficacy of a psychosocial eHealth intervention on the proposed primary outcomes, TKI adherence and health related quality of life (HRQoL), in patients taking TKIs for cancer management.
The intervention components include psychosocial management strategies, cancer medication knowledge and embedded physician reports. The intervention will be delivered via an online application over an 8-week period. Participants in the intervention will complete bi-weekly side effect questionnaires as part of their study involvement, which may trigger an alert to their prescribing physician if they reach a certain threshold. Participants in the control will not complete these questionnaires.
Participants are randomized into either an intervention application (described above) or a control application (health information and general health promotion strategies). Aside from having access to the online application for the recommended 8 weeks, participation in this study includes three assessments: baseline (at the beginning of the research study), post-intervention (8 weeks after baseline) and a 6-month follow-up.
Detailed Description
Molecularly targeted tyrosine kinase inhibitors (TKIs) have improved the overall prognosis of patients with cancer. When properly adhered to, TKIs can extend progression-free survival by decades. Despite the promise of TKIs, nonadherence is problematic and studies report that as little as 23% of patients are fully adherent over time. Poor adherence is of significance as it is associated with disease progression and mortality. Despite the importance of optimal adherence (\<90% adherence for TKIs), only a handful of interventions with very limited documented efficacy have targeted adherence to TKIs. This is problematic as the number of patients receiving oral anticancer medications is steadily increasing and patients taking TKIs are required to be adherent for years to impact survival. Furthermore, the limited half-life of TKIs highlights the need to optimize full adherence to these medications.
The few interventions that have sought to improve oral anticancer medication adherence have been limited by: (a) lack of a conceptual model that incorporates modifiable psychosocial factors (e.g., illness perceptions, self-efficacy) known to influence adherence behaviors, (b) lack of patient-centered education and training to manage the chronic and debilitating burden of the medication side effects, and (c) lack of more than one objective method of tracking participants' medication adherence. Strategies that (a) facilitate patient-provider communication about side effects and side effect monitoring, and (b) incorporate evidence-based tools to improve side effect monitoring and management, as well as coping with illness-related stress, may be especially beneficial for aiding patients to optimally adhere to TKI medications. Therefore, the investigators propose that an evidence-based psychosocial intervention that can improve management of oral anticancer medication side effects, and therefore improve quality of life, may also improve adherence.
Previous work elucidating the determinants of adherence to oral anticancer medications and developing web-based symptom monitoring tools and psychosocial interventions for patients with cancer makes the research team uniquely positioned to develop and evaluate the feasibility of an intervention to improve adherence to life-saving TKI medications. Consistent with PA-17-061 (Oral Anticancer Agents), the investigators propose to establish the feasibility of an evidence-based, web-delivered and adaptive program called Oncotool to improve adherence to TKIs. Oncotool is patient centered and grounded in models of health behavior change, self-management and established barriers (e.g., patient, system and treatment factors) to medication adherence. Oncotool will incorporate patient education (e.g., compliance education, medication adherence benefits), track side effects bi-weekly, notify providers of patient-reported side effects, and provide medical and psychosocial management strategies for TKI medication side effects. The purpose of this study is to compare the efficacy of Oncotool to a control program, which will contain general health information such as cancer screening, diet and physical activity. The primary study outcome will be feasibility of Oncotool (i.e., acceptability, demand, practicality). Adherence and health-related quality of life (HRQoL) will be assessed as secondary outcomes over 6 months in Oncotool compared to the control condition.
#Intervention
- BEHAVIORAL : Oncotool Intervention (symptom reporting + TKI education)
- OncoTool is a website intended to improve self-management practices for helping cancer patients cope with side effects and improve health-related quality of life. OncoTool provides symptom education and management for dealing with the numerous physical and mental side effects associated with TKIs (e.g., fatigue, nausea, skin toxicity). OncoTool is a website designed to improve TKI adherence by improving quality of life and TKI associated symptom burden, as well as providing a portal for provider-patient communication via a bi-weekly health questionnaire. Both intervention and active comparator conditions are administered to participants for 8 weeks.
- BEHAVIORAL : Oncotool Control (health information)
- OncoTool is a health promotion website with health education on subjects like nutrition and exercise specific to cancer patients, as well as general advice on lifestyle choices and prevention. The Oncotool control has similar TKI education content as the experimental content but without the side effect education or physician notification. Both intervention and active comparator conditions are administered to participants for 8 weeks.
|
#Eligibility Criteria:
Inclusion Criteria:
* >= 18 years
* medical chart confirmed diagnosis of cancer
* willingness to be randomized into study
* have initiated TKIs within the past 18 months, as data in literature indicates that the majority of patients who initiate oral anticancer medications are still adherent within the first few months
* willing to use a web-based platform on a bi-weekly basis, as well as an email address and access to the internet
* English speaking, as all material will be in English
Exclusion Criteria:
(a) significant cognitive impairment, inpatient psychiatric treatment, or overt signs of severe psychopathology (e.g., psychosis).
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT03952312
| 14,589
|
{
"NCT_ID" : "NCT03317795",
"Brief_Title" : "Treatment of Heavy Menstrual Bleeding in Women With Uterine Fibroids",
"Official_title" : "Prospective Randomized Trial of Tranexamic Acid Versus Levonorgestrel Intrauterine System for the Treatment of Heavy Menstrual Bleeding in Women With Uterine Fibroids",
"Conditions" : ["Heavy Menstrual Bleeding", "Menorrhagia", "Uterine Fibroids"],
"Interventions" : ["Drug: Tranexamic Acid", "Drug: Levonorgestrel IUS"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE4"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional Model" : "PARALLEL",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
This is a randomized controlled trial (RCT) to assess the comparative effectiveness of Levonorgestrel Intrauterine System (LNG-IUS) to Tranexamic Acid (TA) for the treatment of heavy menstrual bleeding (HMB) in women with clinically-significant fibroids.
Detailed Description
Uterine fibroids are common and debilitating problem for some women. Nearly 60% of women with fibroids report that symptoms affect their quality of life and impede physical activity, and 24% report that fibroid symptoms prevent them from reaching their true potential at work. Heavy menstrual bleeding, the most common symptom of uterine fibroids, affects approximately 1.4 million women per year.
Medical therapy is the first line treatment for heavy menstrual bleeding, but further studies need to be done to prove the effectiveness of these treatments.
The goal of this study is to determine the effectiveness of non-estrogenic medical therapy in women with a range of fibroid sizes, locations, and number.
Two effective medical treatments for heavy menstrual bleeding have limited data in women with fibroids. The Levonorgestrel intrauterine system was FDA approved for the treatment of heavy menstrual bleeding in 2009 and is highly effective for decreasing menstrual bleeding, treating anemia and improving quality of life. Moreover, it can be used continuously for 5 years. Tranexamic Acid is widely used outside the U.S. and was also FDA approved for heavy menstrual bleeding in 2009. Tranexamic Acid reduces menstrual blood loss in 40% of women and improves quality of life. In women with fibroids, Tranexamic Acid has been shown to decrease heavy menstrual bleeding and cause necrosis of the fibroids, especially larger fibroids, which should improve its efficacy for women with fibroids.
This randomized controlled trial will assess the comparative effectiveness of Levonorgestrel intrauterine system to Tranexamic Acid for the treatment of heavy menstrual bleeding in women with uterine fibroids
#Intervention
- DRUG : Levonorgestrel IUS
- LNG-IUS was FDA-approved for the treatment of heavy menstrual bleeding in 2009 and previously for contraception in 2000. The LNG-IUS is a T-shaped device with a polyethylene body containing a hormone reservoir, holding a total of 52 mg of levonorgestrel. LNG-IUS initially releases 20 micrograms of the progestin per day, which decreases to less than half that amount after 5 years of use. The levonorgestrel causes stromal pseudodecidualization, decreases endometrial thickness, and lowers uterine vascular density.
- Other Names :
- Mirena IUS
- DRUG : Tranexamic Acid
- Tranexamic Acid was FDA-approved for the treatment of heavy menstrual bleeding in 2009. Tranexamic Acid is a plasminogen-activator inhibitor that blocks fibrinolysis and reduces plasmin activity. A special formulation was designed for the treatment of heavy menstrual bleeding that reduces gastrointestinal side effects, brand name Lysteda which will be prescribed as 1300 mg to be taken three times per day for up to 5 days of the menstrual period.
- Other Names :
- Lysteda
|
#Eligibility Criteria:
Inclusion Criteria:
* Premenopausal women ages 25 -50
* Monthly menses
* Image-confirmed uterine fibroids of at least 1 cm in size, either submucosal or intramural
* Seeking treatment for heavy menstrual bleeding following completed clinical evaluation
* Self-reported heavy menstrual bleeding for three months or longer
* Completed evaluation for heavy menstrual bleeding within one year of study enrollment
* Understands the English language for consent and questionnaires
* Able and willing to provide informed consent
Exclusion Criteria:
* Class 0 fibroids confirmed by hysteroscopy, saline-infused sonogram, or 3D ultrasound
* Uterine sounding length >= 14 cm
* Uterine size >= 20 weeks gestational size
* Abnormal endometrial biopsy or incomplete clinical testing to rule out malignancy
* Needs or is using hormonal contraception, including estrogen-containing medications
* Venous thromboembolic history, clotting disorder, or strong family history of venous thromboembolic events
* Breast, uterine, or cervical malignancy
* Liver disease or liver tumor
* Pelvic inflammatory disease, gonorrhea or chlamydia infection during the past three months
* Hemoglobin < 8 mg/dL. For women with hemoglobin 8.0 - 12.0 mg/dL, iron supplement is recommended
* Serum creatinine >= 1.4
* Current pregnancy or currently lactating
Sex :
FEMALE
Ages :
- Minimum Age : 25 Years
- Maximum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT03317795
| 22,913
|
{
"NCT_ID" : "NCT00148876",
"Brief_Title" : "TBP Study With Capecitabine Plus Minus Trastuzumab",
"Official_title" : "A Multicenter Randomized Phase III Study to Compare Capecitabine Alone or in Combination With Trastuzumab in Patients With HER2 Positive Metastatic Breast Cancer and Progression After Previous Treatment With Trastuzumab",
"Conditions" : ["Breast Cancer"],
"Interventions" : ["Drug: Capecitabine", "Drug: Trastuzumab"],
"Location_Countries" : ["Germany"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE3"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional Model" : "PARALLEL",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
This study is done in patients having Breast Cancer with metastasis (patients with positive receptor HER2) whose disease progressed after receiving Trastuzumab.
The primary objective of this study is to compare the time until disease progression between the Treatment Arm CAPECITABINE and the Treatment Arm CAPECITABINE + TRASTUZUMAB
The study has also other secondary and tertiary objectives.
Detailed Description
Trial design:
Prospective, multi-center, controlled, non blinded, randomized phase III Study
Treatment:
Patients with HER2 positive metastatic breast cancer and progression after previous treatment with trastuzumab are being randomized to either:
A. Capecitabine 2500 mg/m² orally day 1-14 q day 22 until progression \* and discontinuation of Trastuzumab
B. Capecitabine and Trastuzumab:
Capecitabine 2500 mg/m² orally day 1-14 q day 22 until progression \* Trastuzumab 6 mg/kg body weight every 3 weeks i.v. as a 90 min infusion until progression \*
Objectives:
Primary objective:
To compare the time to disease progression in patients with HER2 positive metastatic breast cancer and progression after previous treatment with trastuzumab randomized to capecitabine alone or in combination with trastuzumab.
Secondary objectives:
To compare the objective response rate between the two arms To compare the duration of response To compare the clinical benefit defined as CR, PR, or stable disease \> 24 weeks between the two arms To evaluate the safety of the capecitabine + trastuzumab combination To compare overall survival between the two arms
Tertiary objective:
To determine the HER2 status in tissue collected directly before study entry
#Intervention
- DRUG : Capecitabine
- Capecitabine 2500 mg/m² orally day 1-14 q day 22
- DRUG : Trastuzumab
- Trastuzumab 6 mg/kg body weight every 3 weeks i.v.
|
#Eligibility Criteria:
Inclusion Criteria:
* Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and follow-up, must be obtained and documented according to the local regulatory requirements.
* Pathologically confirmed carcinoma of the breast.
* Locally advanced or metastatic stage of disease not suitable for surgery or radiotherapy alone.
* HER2-overexpression of the primary or metastatic tumor tissue detected by immunohistochemistry (DAKO) 3+ or gene namplification detected by FISH. HER2-positive primary tumours with HER2-negative metastasis can be included.
* Disease progression during or after previous chemotherapy and trastuzumab treatment as follows (Trastuzumab has to be given previously for at least 12 weeks, treatment free interval of trastuzumab for a maximum of 6 weeks):
* Taxanes + trastuzumab given as adjuvant therapy
* Taxanes + trastuzumab given as first line therapy for palliation
* Trastuzumab given as first line therapy for palliation alone or in combination with chemotherapeutic agents other than capecitabine or taxanes
* No more than 1 chemotherapy for palliation (max. Adriamycin dose < or = 400 mg/m²; Epirubicin < or = 600 mg/m²)
* Patients must have either measurable or nonmeasurable target lesions according to the RECIST criteria (see Appendix 6)
* At least 4 weeks since radiotherapy, with full recovery. The measurable disease must be completely outside the radiation portal or there must be pathologic proof of progressive disease
* At least 4 weeks since major surgery with full recovery.
* Complete radiology and tumor measurement work up within 4 weeks prior to registration:
* Karnofsky performance status evaluation > or = 60%
* Age >18 years.
* Absolute neutrophil count > or =1,500 cells/microL, platelet count > or =100,000 cells/microL.
* Bilirubin < or = 2x the upper limit of normal for the institution (ULN); elevation of transaminases and alkaline phosphatase < 2.5x ULN or <5x ULN for patients with liver metastases.
* Creatinine < or = 2.0 mg/dl.
* Left ventricular ejection fraction (LVEF) by cardiac ultrasound of > or = 50%.
* If of childbearing potential, pregnancy test is negative. In addition the patient agrees to use an effective method to avoid pregnancy for the duration of the study.
Exclusion criteria:
* Known hypersensitivity reaction to the compounds or incorporated substances or known dihydropyrimidine dehydrogenase deficiency.
* Concurrent immunotherapy or hormonal therapy (antihormonal, contraceptive and/or replacement therapy). Bisphosphonates may be continued.
* Parenchymal brain metastases, unless adequately controlled by surgery and/or radiotherapy with complete resolution of symptoms and of all steroids.
* Life expectancy of less than 3 months.
* Serious intercurrent medical or psychiatric illness that may interfere with the planned treatment (including severe pulmonary conditions, AIDS and serious active infection).
* History of congestive heart failure or other significant uncontrolled cardiac disease.
* History of other malignancy within the last 5 years which could affect the diagnosis or assessment of breast cancer.
* Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry.
* Treatment with sorivudine or derivates e.g. brivudin
* Pregnant or nursing women.
* Male patients.
* The patient must be accessible for treatment and follow-up. Patients registered on this trial must be treated and followed at the participating centre which could be the Principal or Co- investigator's site.
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT00148876
| 1,620
|
{
"NCT_ID" : "NCT03391232",
"Brief_Title" : "PolyPEPI1018 Vaccine and CDx for the Treatment of Metastatic Colorectal Cancer (OBERTO)",
"Official_title" : "Safety, Tolerability, Immunogenicity and Efficacy of Multiple PolyPEPI1018 Vaccinations as an Add-on Immunotherapy to the Standard-of-Care Maintenance Therapy in Subjects With Metastatic Colorectal Cancer",
"Conditions" : ["Colorectal Cancer"],
"Interventions" : ["Biological: PolyPEPI1018 CRC Vaccine"],
"Location_Countries" : ["Italy", "United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1", "PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional Model" : "SINGLE_GROUP",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
Phase I/II clinical trial investigates the safety, tolerability, immunogenicity and preliminary efficacy of multiple doses of PolyPEPI1018 CRC vaccine as an add-on treatment to the standard-of-care maintenance therapy in patients with metastatic colorectal cancer. Clinical responses will be evaluated by indiction of T cell responses, T lymphocyte infiltration in accessible biopsy sites, and by objective tumor responses. This study will also explore the accuracy of the predicted T cell responses in each patient using the candidate companion diagnostic test and the correlations between clinical responses and predicted T cell responses.
Detailed Description
This is a Phase I/II, open-label, single-arm, multicenter study to evaluate the safety, tolerability, immunogenicity and efficacy of a multiple subcutaneous injection of PolyPEPI1018 as an add-on immunotherapy to the standard-of-care maintenance therapy in approximately 15 subjects with metastatic colorectal cancer.
The first part of the study investigates the administration of a single vaccine dose during 12-week follow-up period on an outpatient basis. Screening is performed in parallel with the subject's completion of the standard-of-care first-line treatment and initiation of the standard-of-care maintenance treatment. A single dose of PolyPEPI1018 is administered after the subject initiates the maintenance regimen, and within 3 weeks after the eligibility CT scan was performed. Subjects are monitored every 3 weeks for 12 weeks.
The second part of the study investigates the administration of 3 vaccine doses (Weeks 0, 13, 26) then 12 weeks follow-up on an outpatient basis.
#Intervention
- BIOLOGICAL : PolyPEPI1018 CRC Vaccine
- Colorectal Cancer Vaccine
|
#Eligibility Criteria:
Inclusion Criteria:
* Male or female subjects, 18 <= age <= 75 years at time of Screening who provide written informed consent prior to initiation of any study procedure
* Histologically confirmed metastatic adenocarcinoma originating from the colon or the rectum
* Presence of at least 1 measurable reference lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria
* Experienced PR or stable disease during first-line treatment with a systemic chemotherapy regimen and 1 biological therapy regimen
* Maintenance therapy with a fluoropyrimidine (5-fluorouracil or capecitabine) plus the same biologic agent (bevacizumab, cetuximab or panitumumab) used during induction, scheduled to initiate prior to the first day of treatment with the study drug
* No more than 1 line of chemotherapy regimen for mCRC (adjuvant therapy for non-metastasized disease is allowed if terminated more than 6 months before Screening and without recurrence within 6 months after the end of adjuvant treatment)
* Last CT scan at 3 weeks or less before the first day of treatment
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Women of childbearing potential must agree to appropriately use an effective form of contraception (failure rate of <1% per year) for 3 months from the day of the treatment. An effective form of contraception is defined as using hormonal contraceptives or an intrauterine device combined with at least 1 of the following forms of contraception: a diaphragm, cervical cap or condom
* Men must agree to use an effective form of contraception (as defined above), and not donate sperm for 3 months from the day of the treatment
* White blood cell count >=3.0 × 109/L with neutrophils >=1.5 × 109/L
* Platelets >=100 × 109/L, hemoglobin >=5.6 mmol/L (corresponding to 9 g/dL)
* Serum bilirubin <=1.5 × upper limit of normal (ULN) set by the site
* Alanine amino transferase (ALAT) and aspartate amino transferase (ASAT) <=2.5 × ULN in the absence of liver metastases. ALAT and ASAT <=5 × ULN set by the site in the presence of liver metastases
* Serum creatinine <=1.5 × ULN set by the site and creatinine clearance >30 mL/min using Cockroft formula
* Relevant toxicities of prior therapies must have resolved, except for oxaliplatin-related neuropathy or alopecia
* Anticipated life expectancy >=6 months Subject is willing and able to comply with the requirements of the protocol
Exclusion Criteria:
* Received chronic systemic immune therapy or immunosuppressant medication other than steroids within the last 6 weeks prior to start of study treatment
* Received continuous systemic steroid treatment within the last 2 weeks prior to start of study treatment
* Colorectal cancer with documented high microsatellite instability (MSI-H)
* Colorectal cancer with documented BRAF mutations
* Pre-existing systemic autoimmune or antibody-mediated diseases or immune deficiency diseases
* Central nervous system (CNS) metastases
* Active or uncontrolled severe infections or undiagnosed febrile condition >38ºC
* Acute or subacute intestinal obstruction or history of chronic intestinal inflammatory diseases
* Symptomatic peritoneal carcinomatosis
* Peritonitis
* Serious, non-healing wounds, ulcers or bone fractures
* Nephrotic syndrome
* Arterial thromboembolisms or severe hemorrhages within 6 months before study enrolment (except bleeding tumor before tumor resection surgery)
* Hemorrhagic diathesis or thrombotic tendency
* Major surgery or radiotherapy within 12 weeks prior to the study treatment or anticipation of needing such procedure during the study period
* Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage more than once every 28 days
* Participants with active malignancy (other than colorectal cancer) or a prior malignancy within the past 12 months
* Participant with myocardial infarction within 6 months prior to enrollment or New York Heart Association Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to the first dose of study treatment, any electrocardiogram (ECG) abnormality at Screening must be documented by the investigator as not medically relevant
* Administration of a live, attenuated vaccine within 4 weeks before randomization or anticipation of a live attenuated vaccine will be required during the study
* Participant has participated in another clinical study involving an investigational product (IP) or investigational device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study
* Known hypersensitivity to any component of the investigational drug
* If female, participant is pregnant (exclusion confirmed with beta-human chorionic gonadotropin [hCG] test) or lactating at the time of enrollment, or has plans to become pregnant or start breastfeeding during the study
* Pre-existing alcohol or drug abuse
* Medical or mental impairments which make it impossible to obtain the patient's consent or to conduct the study
* A significant concomitant medical condition which the clinical investigator believes precludes the patient from enrolling in the study Absent or limited legal competence
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT03391232
| 30,834
|
{
"NCT_ID" : "NCT00569231",
"Brief_Title" : "Study With Candida Antigen for Treatment of Warts",
"Official_title" : "A Phase 1 Study to Evaluate the Immunologic Mechanisms Underlying Wart Resolution After Intralesional Immunotherapy With Candida Antigen",
"Conditions" : ["Warts", "HPV"],
"Interventions" : ["Drug: Candida Antigen"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Allocation" : "NON_RANDOMIZED",
"Interventional Model" : "SINGLE_GROUP",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
The purpose of this study is to look at how people respond to the treatment of warts through use of the Candida antigen to get an immune response to rid the body of human papillomavirus (HPV). The immune system is the part of the body that fights infections like HPV which causes warts. This research study will examine the response of your wart when injected with a portion of a common yeast (candida) which is the study drug. Your immune system response will also be looked at by doing a test called an ELISPOT assay. This test is done on blood samples. The results of this test may help us to determine how the Candida antigen affects your wart.
Detailed Description
The use of recall antigens for treating warts is not yet Food and Drug Administration (FDA) approved. The primary goal of this work was to assess the safety of Candin as an investigational new drug (IND) for the treatment of warts. In addition, clinical resolution of treated and untreated warts was evaluated and immunologic responses were examined using an ex vivo interferon-γ enzyme-linked immunospot (IFN-γ ELISPOT) assay in order to elucidate the immunologic mechanisms behind the successful regression of warts in patients undergoing Candin injection immunotherapy.
#Intervention
- DRUG : Candida Antigen
- Intralesional injection of 0.3ml candida antigen into largest wart at baseline visit and then every 3 weeks +/- 3 days for a maximum of 10 treatments.
- Other Names :
- Candin
|
#Eligibility Criteria:
Inclusion Criteria:
* Subjects must be ages 18 <= age <= 50.
* Female subjects of child-bearing potential must have a negative urine pregnancy test before each treatment.
* Female subjects of child-bearing potential agree to use a reliable form of birth- control as the risks associated with candida antigens during pregnancy are not known.
* Subjects must have two or more cutaneous, non-genital, non-facial warts.
* Subjects must be able to provide written, informed consent.
* Subjects must be willing to comply with the requirements of the protocol.
* Subjects vital signs must be within the following parameters at time of enrollment:
* Blood Pressure - <150/95 mmHg
* Temperature - <100.4° F
* Pulse Rate - 50 to 100 beats/minute
* Respiratory Rate - <24 breaths/minute
Exclusion Criteria:
* Subjects who have a history of disease or treatment that has caused the subject to be immunosuppressed to include, but not limited to, cancer, HIV, or organ transplantation. Immunosuppression will be determined only by medical history.
* Subjects who are pregnant, lactating, or attempting to become pregnant, as the risks associated with candida antigens during pregnancy are not known.
* Subjects who have only genital or facial warts.
* Subjects who are unable to return for follow-up visits or comply with the protocol.
* Subjects who have a known allergy to Thimerosol or the candida antigen.
* Subjects who have a history of asthma as determined by a medical history or treatment for an asthmatic episode.
* Subjects who have any type of diabetes.
* Subjects who are currently using non-selective Beta Blockers.
* Subjects who are currently using H2 antagonists (e.g., cimetidine). There will be a 24 hour washout period for any use of H2 antagonists prior to beginning treatment in the study.
* Subjects who have a history of keloid formation.
* Subjects who have a history of alcohol or illicit drug abuse, as determined only by medical history.
* Subjects who have had previous treatment with candida antigens for their warts.
* Subjects who are currently using any other treatments for their warts. This includes prescription or over-the-counter medications. Subjects must have a wash¬out period of 30 days for any previous treatments prior to beginning the study.
* Subjects with a blood pressure >150/95, temperature >100.4° F, pulse rate <50 or >100 beats per minute, and respiratory rate >24 at time of enrollment.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT00569231
| 2,422
|
{
"NCT_ID" : "NCT02171741",
"Brief_Title" : "Dose Escalation Trial of BIBW 2992 Administration in Combination With Docetaxel in Patients With Advanced Solid Tumors",
"Official_title" : "A Phase I Dose Escalation Trial of BIBW 2992 Administration for 20, 13 or 6 Days in Combination With Docetaxel Every 21 Days",
"Conditions" : ["Neoplasms"],
"Interventions" : ["Drug: BIBW 2992", "Drug: Docetaxel"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional Model" : "SINGLE_GROUP",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
Study to determine the maximum tolerated dose (MTD) for various treatment durations of BIBW 2992 when administered in combination with docetaxel as determined by drug-related adverse events (AEs) as well as Pharmacokinetics, overall safety and antitumor efficacy.
#Intervention
- DRUG : BIBW 2992
- continuous daily dosing for 20 or 13 days
- DRUG : Docetaxel
- single infusion on day 1
|
#Eligibility Criteria:
Inclusion Criteria:
* Male or female patients with confirmed diagnosis of advanced, non-resectable and / or metastatic solid tumors, of types historically known to express EGFR and/or HER2, who are amenable to docetaxel, preferably patients with breast, prostate, or non-small cell lung cancer. Patients must have failed prior standard therapies associated with clinical benefits, including survival benefits, if such therapies are available. If docetaxel administration is standard therapy associated with clinical benefits, patients are eligible
* Age >= 18 years
* Life expectancy of at least three (3) months
* Written informed consent that is consistent with International Conference on Harmonization - Good Clinical Practice guidelines
* Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1
* Patients must have resolution from prior chemo-, hormone-, immuno-, or radiotherapy related toxicities to CTC Grade <= 1or baseline for individual patient
* Patients must be recovered from previous surgery
Exclusion Criteria:
* Active infectious disease
* Gastrointestinal disorders that may interfere with the absorption of the study drug or chronic diarrhea
* Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the protocol
* Patients with untreated or symptomatic brain metastases. Patients with treated, asymptomatic brain metastases are eligible if there has been no change in brain disease status for at least eight weeks, no history of cerebral edema or bleeding in the past eight weeks and no requirement for steroids or anti-epileptic therapy
* Cardiac left ventricular function with resting ejection fraction >= CTC Grade 1
* Absolute neutrophil count (ANC) less than 1500 / mm3
* Platelet count less than 100 000 / mm3
* Bilirubin > upper limit of normal (ULN)
* Aspartate amino transferase (AST) and / or alanine amino transferase (ALT) > 1.5 x ULN
* Alkaline Phosphatase > 2.5 x ULN
* Serum creatinine > 1.5 mg / dl (> 132 μmol / L, SI (Système Internationale) unit equivalent)
* Women and men who are sexually active and unwilling to use a medically acceptable method of contraception
* Pregnancy or breast-feeding
* Concurrent treatment with other investigational drugs, or chemotherapy, immunotherapy, radiotherapy or hormone therapy (excluding Luteinizing hormone-releasing hormone agonists, or other hormones taken for breast cancer, or bisphosphonates) or participation in another clinical study within the past four weeks before start of therapy or concomitantly with this study
* Treatment with an EGFR- or HER2 inhibiting drug within the past four weeks before start of therapy or concomitantly with this study (8 weeks for trastuzumab)
* Patients unable to comply with the protocol
* Active alcohol or drug abuse
* Hypersensitivity to docetaxel or any component or other drug formulated with polysorbate 80
The patient may be eligible for re-treatment after the previous course is finished. The patient will not be eligible if any of the following conditions are met:
* If patients' latest X-ray, CT or MRI reveals progressive disease, or if clinical assessment reveals signs of disease progression
* Cardiac left ventricular function CTC Grade >= 2 at any time during the previous course
* Patients fulfilling any of the Exclusion Criteria listed before as determined before treatment Day 1 of any new course
* Patient not recovered from any dose-limiting toxicity (DLT) 14 days after onset. Recovery is defined as a return to baseline level or CTC Grade 1, whichever is higher
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT02171741
| 26,891
|
{
"NCT_ID" : "NCT02523430",
"Brief_Title" : "HepaSphere Interventional Therapy Using Digital Subtraction Angiography（DSA） for Nasopharyngeal Carcinoma",
"Official_title" : "HepaSphere Interventional Therapy Using Digital Subtraction Angiography（DSA） for Nasopharyngeal Carcinoma: Clinical Trial",
"Conditions" : ["Nasopharyngeal Carcinoma"],
"Interventions" : ["Procedure: interventional therapy"],
"Location_Countries" : ["China"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1", "PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional Model" : "PARALLEL",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of HepaSphere interventional therapy using digital subtraction angiography（DSA） for nasopharyngeal carcinoma.
Detailed Description
By enrolling patients with nasopharyngeal carcinoma adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of HepaSphere interventional therapy using digital subtraction angiography （DSA） for nasopharyngeal carcinoma.
#Intervention
- PROCEDURE : interventional therapy
- nasopharyngeal carcinoma patients received HepaSphere interventional therapy using the digital subtraction angiography（DSA）
|
#Eligibility Criteria:
Inclusion Criteria:
* Age:18 <= age <= 80
* Karnofsky performance status >60
* Diagnosis of nasopharyngeal carcinoma based on histology or the current accepted radiological measures.
* Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ
* Will receive interventional therapy
* Life expectancy: Greater than 3 months
* Patients' routine blood test, liver function and kidney function have no obvious abnormalities
* Ability to understand the study protocol and a willingness to sign a written informed consent document
Exclusion Criteria:
* Patients with other primary tumor except nasopharyngeal carcinoma
* History of coagulation disorders or anemia
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT02523430
| 3,848
|
{
"NCT_ID" : "NCT01462864",
"Brief_Title" : "Development of a Structured Education Programme for Women With Polycystic Ovary Syndrome",
"Official_title" : "StructUred eduCation Programme to Improve Cardiovascular Risk in womEn With polycyStic Ovary Syndrome; SUCCESS Study",
"Conditions" : ["Polycystic Ovary Syndrome"],
"Interventions" : ["Behavioral: Structured Lifestyle Education"],
"Location_Countries" : ["United Kingdom"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "PREVENTION",
"Allocation" : "RANDOMIZED",
"Interventional Model" : "PARALLEL",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
Polycystic Ovary syndrome (PCOS) is a common hormonal imbalance affecting about 12% of women in the UK. The number of women with PCOS is rising. They suffer from a combination of symptoms including excess hair, irregular/absent periods, and infertility. About 70% of women with PCOS are obese or overweight, 10% develop type 2 diabetes (T2DM), and 30-40% have some degrees of abnormality in controlling (metabolising) blood sugar. Studies have shown that if women with PCOS make change to their lifestyle (diet and activity), they may reduce their risk of getting diabetes and heart disease in the future. This study aims to develop and test a programme that can be run in groups (structured education), to support women with PCOS make the lifestyle changes needed to improve their PCOS and prevent future associated health problems. Structured education programmes are suitable for use within the NHS and are already recommended for individuals with T2DM, but have not been tested as a method of treatment for PCOS which is a high risk condition for T2DM.
The investigators aim to initially develop a specific education programme for women with PCOS using their expertise in their disease and defining their needs. The next step is to test this programme on 160 women with PCOS who will be selected from the investigators database or clinics. They will be divided randomly to two groups to receive either this programme or routine care.
The investigators will give them an accelerometer (a very small portable device). This will measure their physical activity and counts their daily steps. The investigators aim is to increase their step count by at least 2000 steps per day after one year.
The investigators believe that the group given the structured education will show some evidence of improvement in their glucose metabolism, and consequently decreased chance of developing diabetes.
Detailed Description
Overview of project plan:
Development of the structured education course: Year 1 (Phases 1\&2)
Phase 1:
The SUCCESS intervention (structured education programme to improve cardiovascular risk in women with PCOS) will be developed and piloted in line with the Medical Research Council's framework for complex interventions. This will involve recruiting participants for focus groups and interviews to allow the research group to develop a detailed understanding of what the requirements of the structured education course are.
Inclusion criteria for patients in this phase is women with a clear diagnosis of PCOS based on Rotterdam 2003 Criteria or National Institute of Health 1992 And 18\< age \<70 years Participants will be recruited from a database of patients in our speciality clinic and also primary care if needed and the interviews/ focus groups will be held in locations close to the participant, or over the telephone.
Analysis of these sessions will provide invaluable data for the development of the structured education course.
As part of this phase of the study we will perform a systematic review of the literature on the previous lifestyle interventions in the PCOS.
We will also perform a demographic analysis of almost 2400 patients with diagnosis of PCOS in University Hospitals of Leicester database. We already have the ethical approval for the conducting routine database linkage studies including a linkage with the hospital admission database in local Health Informatics Service. Demographic distribution of diagnosis, complications of PCOS, cardiovascular outcomes, and reported comorbidities besides other information such as deprivation score will inform us of the important issues need to be considered in development of an education intervention for women with PCOS in phase 2 and 3.
Phase 2
Once the course has been designed, it will be piloted in one or two groups of women with PCOS to get feedback on the content and delivery. These feedbacks will be incorporated in the course and contents will be refreshed and refined.
For the above mentioned pilot sessions, patients will only attend a 3.5 hours education session and no test or measurement will be done.
After each session their views on the content and delivery of the education will be sought. We will continue to run these pilot sessions until we get no further new comments. Previous experience with other similar interventions has shown that two pilot sessions are enough.
When the education programme is ready we can test its efficacy in a randomised controlled trial.
Phase 3; Randomised controlled trial: Years 2 \& 3
The primary hypothesis of the randomised controlled trial is:
'Structured education can increase physical activity measured as walking steps in women with polycystic ovary syndrome.'
Study design:
This is a randomised controlled community based trial. Participants will be randomised to either the intervention or control group at the beginning. A controlled design for the current study is essential given that it is unknown whether structured education is effective at initiating a lifestyle change and whether it translates into improvements in important markers of metabolic and vascular health. Therefore in order to inform health policy evidence is needed from high quality randomized controlled trials carried out in a community setting.
Our study intervention will not interfere with the routine care of a woman diagnosed with PCOS, whether the patient is recruited from speciality clinics or in primary care.
#Intervention
- BEHAVIORAL : Structured Lifestyle Education
- A 3-4 hours group education delivered in a patient group composed of 4-8 patients and delivered by two healthcare professionals.
|
#Eligibility Criteria:
Inclusion Criteria:
* Females aged between 18 <= age <= 50 years with the diagnosis of PCOS according to Rotterdam Criteria 2003 who are Overweight: (WHO 2010)
* Body Mass Index >= 23 kg/m2 for Black and Minor Ethnicities
* Body Mass Index >= 25 kg/m2 for White Europeans
* If already on medical treatment for their PCOS, they should be on a stable regime for at least 6 months prior to the recruitment.
Exclusion Criteria:
* Physical condition which limits full participation in the study
* Active psychotic illness or a significant illness which, in the view of the investigators, would prevent full participation
* Inability to communicate in verbal and written English
* Steroid use
* Diabetes
* Pregnancy
* Involvement in other research studies with similar nature
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT01462864
| 24,466
|
{
"NCT_ID" : "NCT01194791",
"Brief_Title" : "Lendexal in Patients With Primary Systemic Amyloidosis (AL) Newly Diagnosed",
"Official_title" : "A Multicentric, Phase II Trial of Lenalidomide, Cyclophosphamide and Dexamethasone in Patients With Primary Systemic Amyloidosis (AL) Newly Diagnosed, Not Candidates for Hematopoietic Stem Cell Transplantation",
"Conditions" : ["Primary Systemic Amyloidosis"],
"Interventions" : ["Drug: Lenalidomide", "Drug: Cyclophosphamide", "Drug: Dexamethasone"],
"Location_Countries" : ["Spain"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NON_RANDOMIZED",
"Interventional Model" : "SINGLE_GROUP",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
Primary outcome measure:
- Hematologic response rate to the association of Lenalidomide, Cyclophosphamide and Dexamethasone.
Secondary outcome measures:
* Organ response rate.
* Predictors of response (cardiac biomarkers, serum free light chains).
* Toxicity
* Safety (type, frequency, severity and relationship of adverse events to the study drug).
* Duration of response.
* Time to progression.
* Overall survival
Detailed Description
It is a multicenter, single arm treatment, phase II study of the combination in one treatment arm with Lenalidomide, Cyclophosphamide and Dexamethasone.
Subjects who qualify for participation will receive lenalidomide plus dexamethasone and cyclophosphamide in 4-week cycles. Subjects will be seen (study visits) every 2 weeks for the first 3 cycles of therapy and monthly thereafter.
Cycles of lenalidomide/dexamethasone/cyclophosphamide will consists of lenalidomide 15 mg by mouth for 21 days followed by 7 days rest and 300 mg/m2 of cyclophosphamide on days 1 and 8 plus oral dexamethasone 20 mg/day on days 1-4 and 9-12 given at 4-week intervals. Patients will be treated with 6 cycles of therapy with the option to continue beyond as long there is evidence of response. In this case the dose of lenalidomide will be the same and the dose of the dexamethasone will be administered only on days 1 to 4 of each cycle and the dose of cyclophosphamide only day 1 during 6 cycles. After 12 cycles if the patients remaining in response, will be treated with 10 mg/day, cyclophosphamide day 1, and dexamethasone will be administered on days 1 to 4 of each cycle.
For the first 3 cycles, patients will be followed for adverse events with hematologic control every 2 weeks and monthly thereafter. Patients will be required to have a blood work-up including total serum protein and serum protein electrophoresis, urine protein studies and a clinical visit before each cycle. Organ involvement will be assessed every 4 cycles during the first year of therapy. Hematologic response will be assessed every 3 months and organ response every 6 months after the first year of treatment.
Treatment modifications will be based on adverse events graded according to the Common Terminology Criteria for Adverse Events (CTCAE Version 3.0).
There will be 30 patients enrolled.
The trial consists of three periods: pre-treatment, treatment and follow up period.
Pre-treatment phase: include the enrolment visit in order to determine if the patient is eligible to participate in the study. The patient will sign the Informed Consent Form to take part in the study, and will receive detailed information about the treatment, its benefits and risks.
Treatment phase: include the 12 cycles of 28 days treatment with Lenalidomide, Cyclophosphamide and Dexamethasone as induction therapy followed with low doses of Lenalidomide and Dexamethasone during three years until progression or unacceptable toxicity levels.
Follow up phase: Once the clinical trial has finished, patients will be followed during usual clinical practice visits where progression, free survival and overall survival will be evaluated.
#Intervention
- DRUG : Lenalidomide
- Lenalidomide 15 mg by mouth for 21 days followed by 7 days rest during 6 cycles
- Other Names :
- Lendexal
- DRUG : Cyclophosphamide
- Cyclophosphamide 300 mg/m2, on days 1 and 8 every 4 weeks during 6 cycles
- DRUG : Dexamethasone
- Oral dexamethasone 20 mg/day on days 1-4 and 9-12 given at 4-week intervals during 6 cycles
|
#Eligibility Criteria:
Inclusion Criteria:
* Understand and voluntarily sign an informed consent form.
* Age > 18 years at the time of signing the informed consent form.
* Able to adhere to the study visit schedule and other protocol requirements according with investigator criteria.
* Diagnosis of symptomatic primary systemic amyloidosis based on tissue Congo red positive staining as well as positive immunohistochemical staining for light chains or presence of a monoclonal protein in serum and/or urine or clonal bone marrow plasma cells
* Previously untreated disease
* Patients should not candidates for up-front high-dose therapy/stem cell transplantation
* Serologically measurable disease defined as follows:
Evidence of a monoclonal light chain in serum and urine by immunofixation Raise of the level of circulating free light chains above the ordinary limits and an abnormal relationship kappa/lambda.
* Performance status ECOG <= 2 (see Annex 3).
* Laboratory tests results within these ranges:
Absolute neutrophil count >= 1 x 10 9/ L. Platelet count >= 100 x 10 9/ L Serum creatinine less than 3.0 mg/dL Serum bilirubin less than 3.0 mg/dL
* Females of childbearing potential (FCBP) must agree to: Know the teratogenic risks of the study drug
Commit to use contraceptives during the 4 weeks before the start of this study drug treatment, during the treatment and also 4 weeks after it, even amenorrheic cases. All of it applies always except women committed to maintain sexual abstinence confirming it monthly. Some of effective contraceptives are:
Birth control implant Levonorgestrel-releasing intrauterine device. Depot medroxyprogesterone acetate Tubal ligation Sexual intercourse only with a vasectomized partner. The effectiveness of vasectomy must be confirmed by two semen analysis; the result must be negative Inhibiting ovulation pill progesterone only (for example: desogestrel) if it is determined that the patient doesn't use an effective contraceptive method will be referred to a skilled health professional to receive advice on contraception, so that they can begin to birth control measures.
It's discouraged combine oral contraceptives in myeloma multiple women cases treated with Lenalidomide combined with Dexamethasone due to high venous thromboembolism risk. In case these kind of patient were having combined oral contraceptives, she must change to another one of list above. Risks of venous thromboembolism will remain during the 3 or 4 weeks after discontinue combine oral contraceptives treatment. Concomitant treatment with dexamethasone reduces the effectiveness of contraceptive steroids.
Implants and levonorgestrel-releasing intrauterine systems are related to higher risks of infections at the moment of the implant or when there is metrorrhagia. It should be considered prophylactic treatment with antibiotics for neutropenic patients.
Normally it's discouraged copper intrauterine devices because of the infection risk and menstrual blood loss at the moment of the implant for patients with neutropenia or thrombocytopenia.
Women patients must follow all warnings for an effective contraception, even if she is amenorrheic.
Women patients must be aware about effects of pregnancy and go to a health care centre urgently in case of pregnancy risk.
She must take a pregnancy test with a minimum sensitivity of 25 mUl/ml, under medical supervision, when the study visits or three days before the visit, when she were 4 weeks at least using effective contraceptive methods. This requirement applies for women who practice a complete and continuous sexual abstinence. Test should confirm that the patient is not pregnant at the time of starting treatment.
She must take a pregnancy test, under medical supervision, each 4 weeks, even a pregnancy test 4 weeks after the end of the study treatment, except in case of a confirmed tubal ligation. Pregnancy test should be performed the day of the study's visit or during the three days before it. This requirement also applies for childbearing women who practice a complete and continuous sexual abstinence.
* Male patients must: Undertake to use latex condoms during treatment with study medication including all periods of interruption of doses, even one week after finishing treatment if his partner is a woman of childbearing who doesn't use contraceptive methods.
Commit not to donate semen during treatment with study medication and even one week after finishing treatment.
* All patients should: Refrain from donating blood during treatment with study medication and even one week after finishing treatment.
Refrain from sharing the study medication with other people and return unused study medication to the investigator or the pharmacist.
Exclusion Criteria:
* Localized cutaneous AL, only carpal tunnel syndrome, merely vascular amyloid in the bone marrow biopsy, AL in a plasmacytoma or AL associated to multiple myeloma (>30% plasma cells in bone marrow, lytic bone lesions, hypercalcemia, plasmacytomas).
* Other causes of amyloidosis (secondary, familial, senile).
* Candidates for high dose chemotherapy/ stem cell transplant.
* Previously treated AL.
* Any condition including laboratory abnormalities, which placed the subjects at unacceptable risk if he/she were to participating the study or confounds the ability to interpret data from the study.
* Use of any other experimental drug or therapy within 28 days prior to baseline.
* Any prior use of lenalidomide
* Any cancer in the previous 5 years, except no melanoma skin cancer, cervix or prostate cancer treated in the initial state with prostate-specific antigen within normal limits.
* Known positive for HIV.
* Cardiac ejection fraction below 50%
* Pregnant or breast-feeding (can not breast-feed while taking lenalidomide)
* Patients who are not able to use antithrombotic prophylaxis or reject.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT01194791
| 226
|
{
"NCT_ID" : "NCT00880971",
"Brief_Title" : "Postoperative Radiotherapy for Patients With IIIA (N2) Non-small Cell Lung Cancer",
"Official_title" : "Post-Operative Radiation Therapy for Patients With pⅢA-N2 Non-Small Cell Lung Cancer After Complete Resection and Adjuvant Chemotherapy: A Prospective Randomized Phase Ⅲ Study",
"Conditions" : ["Thoracic Neoplasms", "Non-small Cell Lung Cancer"],
"Interventions" : ["Radiation: Postoperative 3D-CRT or IMRT"],
"Location_Countries" : ["China"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE3"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional Model" : "SINGLE_GROUP",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
Several important international randomized trials have shown that postoperative chemotherapy contributed to the improvement on 5 year survival rate by about 4% for patients with non-small cell lung cancer (NSCLC) after complete resection. But the overall survival rate was relatively low and the local recurrence was still the dominant failure pattern for stage IIIA (N2) disease even these patients received the postoperative chemotherapy. Several meta-analyses have shown that postoperative radiotherapy (PORT) has no effect on the survival improvement for patients with NSCLC after complete resection. However, sub-group analysis based on the same dataset of these meta-analyses showed that the PORT with conventional radiotherapy might be beneficial for stage IIIA (N2) disease. The 3D conform radiotherapy (3D-CRT) and intensity modified radiotherapy (IMRT) can increase the radiation dose to the target volume while decreasing the dose to risk organs comparing with the conventional radiotherapy. So it is expected that PORT using 3D-CRT or IMRT after postoperative chemotherapy will improve the local control and survival for stage IIIA (N2) NSCLC. Here, the investigators designed a phase III randomized trial to compare the 3-year disease free survival (DFS) and overall survival (OS) rates in patients with completely resected stage IIIA (N2) NSCLC who receive adjuvant chemotherapy alone or adjuvant chemotherapy plus PORT.
Detailed Description
OBJECTIVES:
Primary: To determine whether administering adjuvant chemotherapy (four cycles of platinum-based doublet regimen) plus PORT (50 Gy, 2 Gy once daily over 5 weeks) will improve 3-year DFS compared with adjuvant chemotherapy alone in patients with completely resected stage IIIA (N2) NSCLC.
Secondary: To compare treatment-related toxic effects, 3-year OS, failure-free survival, and the patterns of failure.
OUTLINE: Eligible patients were randomized equally, using simple randomization, to either PORT or observation group.
Arm I: Patients undergo PORT using 3D-CRT or IMRT (50 Gy, 2 Gy once daily over 5 weeks) after adjuvant chemotherapy.
Arm II: Patients undergo adjuvant chemotherapy.
After completion of study treatment, patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
#Intervention
- RADIATION : Postoperative 3D-CRT or IMRT
- Postoperative radiotherapy using 3D-CRT or IMRT techniques, 2 Gy per fraction, total 25 fractions (50Gy) over 5 weeks.
- Other Names :
- Postoperative radiotherapy
|
#Eligibility Criteria:
Inclusion Criteria:
* Completely resected disease by lobectomy, bilobectomy. Complete dissection of lymph nodes at levels 4, 7, and 10 in case of right-sided thoracotomy and at levels 4 (if accessible), 5, 6, 7, and 10 in case of left-sided thoracotomy.
* Histologically N2 disease after surgery. Negative margins
* Has undergone chemotherapy of four cycles of platinum-based doublet regimen and no recurrence and metastasis
Exclusion Criteria:
* Pregnant or nursing
* ECOG performance status > 1
* Post-operative FEV_1 < 1 L (or < 35% theoretical value, PO_2 < 70 mm Hg, and PCO_2 > 45 mm Hg)
* Severe cardiac disease within the past 6 months, including the following: Arrhythmia, Congestive heart failure, Infarction, Pacemaker
* Severe pulmonary disease within the past 6 months
* Other prior or concurrent neoplasm, except for basal cell carcinoma of the skin or carcinoma in situ of the cervix
* Severe or uncontrolled systemic disease
* Familial, social, geographic, or psychological conditions that would preclude study participation
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT00880971
| 33,736
|
{
"NCT_ID" : "NCT02453087",
"Brief_Title" : "A Study of Escalating Doses of DCDS0780A in Participants With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma",
"Official_title" : "An Open-label, Multicenter, Phase 1/1b Dose Escalation Study Evaluating the Pharmacokinetics, Safety, Tolerability, and Preliminary Efficacy of DCDS0780A, Alone or in Combination With Rituximab, or Obinutuzumab, in Patients With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma",
"Conditions" : ["Non-Hodgkin's Lymphoma"],
"Interventions" : ["Drug: Rituximab", "Drug: Obinutuzumab", "Drug: DCDS0780A"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NON_RANDOMIZED",
"Interventional Model" : "PARALLEL",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
This open-label, multicenter, Phase 1/1b study will evaluate the safety, tolerability, and pharmacokinetics of increasing doses of DCDS0780A in participants with relapsed or refractory B-cell non-Hodgkin's lymphoma. In the combination portion of the study, the safety and tolerability of DCDS0780A in combination with rituximab or obinutuzumab will be assessed.
#Intervention
- DRUG : DCDS0780A
- Participants will receive escalating doses of DCDS0780A as intravenous infusion.
- DRUG : Rituximab
- Participants will receive rituximab at a dose of 375 mg/m\^2 of body surface area as intravenous infusion.
- Other Names :
- Rituxan®, MabThera®
- DRUG : Obinutuzumab
- Participants will receive obinutuzumab at a dose of 1000 milligrams (mg) as intravenous infusion.
- Other Names :
- GA101, Gazyva™, Gazyvaro™
|
#Eligibility Criteria:
Inclusion Criteria:
* Life expectancy of at least 12 weeks
* Histologically confirmed B-cell non-Hodgkin's lymphoma that has relapsed after or failed to respond to at least one prior treatment regimen and for which no suitable therapy of curative intent or higher priority exists
* A clinical indication for treatment as determined by the investigator
* Availability of archival or freshly collected tumor tissue before study enrollment
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Fasting (greater than or equal to [>=] 8 hours) glucose less than or equal to (<=) 160 mg/dL
* Participants requiring anti-diabetic medications must be on a stable dose and regimen for >=4 weeks
* Adequate hematologic function without growth factor or transfusion support
* For women who are not postmenopausal (>= 12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use single or combined contraceptive methods as specified in protocol
* For men: agreement to remain abstinent or use a condom plus an additional contraceptive method as specified in protocol
Exclusion Criteria:
* Prior use of any monoclonal antibody or antibody-drug conjugate within 4 weeks before Cycle 1, Day 1
* Treatment with radiotherapy, any chemotherapeutic agent, systemic steroids used as an anti-neoplastic agent, or any other investigational anti-cancer agent within 2 weeks prior to Cycle 1, Day 1
* Completion of autologous stem cell transplant within 100 days prior to Cycle 1, Day 1
* Prior allogeneic stem cell transplant
* Current or history of CNS lymphoma
* Current Grade greater than (>) 1 toxicity (except alopecia and anorexia) from prior therapy
* Current Grade >1 peripheral neuropathy from any cause
* Glycosylated hemoglobin (HbA1c) >=7.5 percent (%)
* History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins)
* Prior irradiation to lung fields
* Clinically significant pulmonary disease
* Recent major surgery within 4 weeks prior to Cycle 1, Day 1, other than superficial lymph node biopsies for diagnosis
* Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
* Presence of positive test results for hepatitis B (hepatitis B surface antigen [HbsAg] and/or total hepatitis B core antibody [anti-HBc]) or hepatitis C (hepatitis C virus [HCV] antibody)
* Known history of human immunodeficiency virus (HIV) seropositive status
* Women who are pregnant or lactating or intending to become pregnant during the study
* Any abnormal laboratory values as specified in protocol
* Requirement for any excluded medication as specified in protocol
* History of other malignancy that could affect compliance with the protocol or interpretation of results
* Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the participant at high risk from treatment complications, including inadequately controlled diabetes or significant cardiovascular disease
* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment or any major episode of infection requiring treatment with intravenous antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 4 weeks prior to Cycle 1, Day 1
* Participants in Phase 1b Stage Only: Vaccination with live vaccines within 6 months before Cycle 1, Day 1
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT02453087
| 32,692
|
{
"NCT_ID" : "NCT03936465",
"Brief_Title" : "Study of the Bromodomain (BRD) and Extra-Terminal Domain (BET) Inhibitors BMS-986158 and BMS-986378 in Pediatric Cancer",
"Official_title" : "Phase 1 Study of the Bromodomain (BRD) and Extra-Terminal Domain (BET) Inhibitors BMS-986158 and BMS-986378 (CC-90010) in Pediatric Cancer",
"Conditions" : ["Solid Tumor, Childhood", "Lymphoma", "Brain Tumor, Pediatric"],
"Interventions" : ["Drug: BMS-986158", "Drug: BMS-986378"],
"Location_Countries" : ["Canada", "United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NON_RANDOMIZED",
"Interventional Model" : "PARALLEL",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
Arm 1 of this research study is studying an investigational drug called BMS-986158 as a possible treatment for pediatric solid tumors or lymphoma. Arm 2 of this research study is studying an investigational drug called BMS-986378 (also known as CC-90010) as a possible treatment for pediatric brain tumors or pediatric tumors that have spread to the brain.
Detailed Description
This is a Phase I clinical trial, which tests the safety of an investigational drug and also tries to define the appropriate dose of the investigational drug to use for further studies. 'Investigational' means that the drug is being studied.
The FDA (the U.S. Food and Drug Administration) has not approved BMS-986158 or BMS-986378 as a treatment for any disease.
BMS-986158 and BMS-986378 are currently still being studied in adults. This is the first time that BMS-986158 or BMS-986378 will be evaluated in younger children, though children 12-17 years of age may also be included in parts of adult studies of BMS-986158.
Research in the laboratory has shown that BMS-986158 and BMS-986378 may have activity against cancer cells. These drugs belong to a group of drugs called Bromodomain (BRD) and Extra-Terminal Domain (BET) inhibitors. These drugs block proteins that are important in reading DNA, which is a process important for cancer cells.
#Intervention
- DRUG : BMS-986158
- BMS-986158 belongs to a group of drugs called Bromodomain (BRD) and Extra-Terminal Domain (BET) inhibitors. These drugs block proteins that are important in reading DNA, which is a process important for cancer cells.
- DRUG : BMS-986378
- BMS-986378 (also known as CC-90010) belongs to a group of drugs called Bromodomain (BRD) and Extra-Terminal Domain (BET) inhibitors. These drugs block proteins that are important in reading DNA, which is a process important for cancer cells.
- Other Names :
- CC-90010
|
#Eligibility Criteria:
Inclusion Criteria:
* Age <= 21 years at time of enrollment. Note the requirement in section 3.1.6 that all patients must be able to swallow intact capsules.
* Karnofsky performance status >= 50% for patients >=16 years or Lansky >= 50% for patients <16 years (see Appendix A)
* Diagnosis requirement
* Participants must have evaluable or measurable disease (see Section 11).
* Must have disease that is relapsed or refractory and for which standard curative measures do not exist or are no longer effective.
* For Arm 1, Cohort 1A, participants must have histologically confirmed non-CNS primary solid tumors or lymphoma based upon biopsy or surgery at relapse/progression. Patients without biopsy or surgery at relapse/progression and with tissue only available from initial diagnosis may still be considered after discussion with the overall Primary Investigator.
* For Arm 1, Cohort 1B, participants must have histologically confirmed solid tumors or lymphoma based upon biopsy or surgery at relapse/progression as well as documentation of one of the following confirmed tumor molecular features obtained in a laboratory certified to return results for clinical purposes. Patients without biopsy or surgery at relapse/progression and with tissue only available from initial diagnosis may still be considered after discussion with the overall Primary Investigator.
* MYCN amplification or high copy number gain
* MYC amplification or high copy number gain
* Translocation involving MYC or MYCN
* Translocation involving BRD4 or BRD3
* BRD4 amplification or high copy number gain
* Histologic diagnosis of NUT midline carcinoma
* For Arm 2, Cohort 2A, participants must have histologically confirmed primary CNS p tumors or untreated CNS metastases based upon biopsy or surgery at relapse/progression. Patients without biopsy or surgery at relapse/progression and with tissue only available from initial diagnosis may still be considered after discussion with the overall Primary Investigator.
* For Arm 2, Cohort 2B, participants must have histologically confirmed primary CNS p tumors or untreated CNS metastases based upon biopsy or surgery at relapse/progression as well as documentation of one of the following confirmed tumor molecular features obtained in a laboratory certified to return results for clinical purposes. Patients without biopsy or surgery at relapse/progression and with tissue only available from initial diagnosis may still be considered after discussion with the overall Primary Investigator.
* MYCN amplification or high copy number gain
* MYC amplification or high copy number gain
* Translocation involving MYC or MYCN
* Translocation involving BRD4 or BRD3
* BRD4 amplification or high copy number gain
* Histologic diagnosis of NUT midline carcinoma
* Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy except organ function as noted in Section 3.1.5. Patients must meet the following minimum washout periods prior to enrollment:
* Myelosuppressive chemotherapy: At least 21 days after the last dose of myelosuppressive chemotherapy (42 days for nitrosourea or mitomycin C).
* Radiotherapy:
* At least 14 days after local XRT (small port, including cranial radiation);
* At least 90 days must have elapsed after prior TBI, or if >50% radiation of pelvis;
* At least 180 days must have elapsed after prior craniospinal XRT;
* At least 42 days must have elapsed if other substantial BM radiation;
* At least 42 days must have passed since last MIBG or other radionuclide therapy.
* Small molecule biologic therapy: At least 7 days following the last dose of a small molecule biologic agent. For agents with known adverse events occurring beyond 7 days, this duration must be extended beyond the time in which adverse events are known to occur. If extended duration is required, this must be discussed with and approved by the overall PI.
* Monoclonal antibody: At least 28 days must have elapsed after the last dose of therapeutic monoclonal antibody.
* Myeloid growth factors: At least 14 days following the last dose of long-acting growth factor (e.g. Neulasta) or 7 days following short-acting growth factor.
* Autologous hematopoietic stem cell transplant and stem cell boost: Patients must be at least 60 days from day 0 of an autologous stem cell transplant or autologous stem cell boost.
* Cellular therapies (including CAR-T cells) and other non-cellular, non-antibody immunotherapies (e.g., vaccines): At least 42 days must have elapsed after last dose.
* Major Surgery: At least 2 weeks from prior major surgical procedure. Note: Major surgical procedure will be considered all surgical procedures aside from the following: Biopsy; central line placement/removal; bone marrow aspirate/biopsy; lumbar puncture; dental procedures; gastrostomy tube placement; and VP shunt placement/revision.
* BET inhibitors: Patients must not have received prior treatment with a BET inhibitor, except patients with CNS tumors or CNS metastasis previously treated on Arm 1 of the trial who discontinued protocol therapy due to disease progression and not due to toxicity. Such patients may participate in Arm 2 of the trial.
* Participants must have normal organ function as defined below.
* Bone Marrow Function
* For Patients without Documented Bone Marrow Involvement by Disease:
* Hemoglobin > 8 g/dL (may be transfused)
* Absolute neutrophil count >= 1,000 /uL
* Platelets >= 100,000 /uL and transfusion independent, defined as not receiving a platelet transfusion for at least 5 days prior to CBC documenting eligibility.
* For Patients with Documented Bone Marrow Involvement by Disease:
* Hemoglobin > 8 g/dL (may be transfused)
* Absolute neutrophil count >= 750 /uL
* Platelets >= 75,000 /uL and transfusion independent, defined as not receiving a platelet transfusion for at least 5 days prior to CBC documenting eligibility.
* Hepatic Function:
* Total bilirubin <= 1.5 x upper limit of normal for age (patients with known Gilbert's may be considered after discussion with overall PI and if direct bilirubin is at or below the upper limit of normal for age)
* ALT (SGPT) <= 3 x upper limit of normal (135 U/L) For the purpose of this study, the ULN for ALT is 45 U/L
* Serum albumin > 2 g/dL
* Adequate Pancreatic Function:
--Lipase < upper limit of normal
* Adequate GI Function:
--Diarrhea < grade 1 by CTCAE version 5
* Coagulation Factors:
* International Normalized Ratio (INR) < 1.5
* Partial thromboplastin time (PTT) < 1.5 times upper limit of normal
* For patients having labs drawn via heparinized catheters, it is important to request heparin-absorbed values.
* Adequate Cardiac Function:
--QTc < 480 msec
* Renal Function:
* A serum creatinine within protocol limits based on age/sex.
OR
* Creatinine clearance >= 60 mL/min/1.73 m2 for participants with creatinine levels greater than the above age/sex maximum allowed values.
* Able to swallow intact capsules (BMS-986158) or tablets (BMS-986378, also known as CC-90010).
* Patient (or parent or legally authorized representative, if minor) is able to understand and willing to provide informed consent, using an institutionally approved informed consent procedure.
* Participants of childbearing or child-fathering potential must agree to use adequate contraception throughout their participation following the guidance in Appendix H.
Exclusion Criteria:
* Prior solid organ or allogeneic stem cell transplantation.
* Patients with primary or metastatic CNS tumors are not eligible for Arm 1, except:
--Patients with a history of CNS metastatic disease that has been resected and/or radiated without evidence of active CNS disease for 3 months preceding enrollment; NOTE: patients with primary CNS tumors or solid tumors with active CNS metastases will be eligible for Arm 2.
* Patients receiving any of the following prohibited foods and medications:
* Agents listed in Appendix B within 7 days prior to enrollment
* Grapefruit or Seville oranges and/or their juices within 7 days prior to enrollment
* Non-steroidal anti-inflammatory drugs, oral anticoagulants, and therapeutic heparins (unfractionated or low molecular weight heparin) at the time of enrollment. Note: Use of heparin to maintain patency of a central or peripheral catheter is allowed
* Other investigational agents being administered under an IND.
* Pregnant participants will not be entered on this study given that the effects of BMS-986158 and BMS-986378 (CC-90010) on the developing human fetus are unknown. Female participants of childbearing potential must have a documented negative pregnancy exam within 24 hours prior to dosing.
* Breastfeeding mothers are not eligible, because there is an unknown risk for adverse events in nursing infants secondary to treatment of the mother with BMS-986158 or BMS-986378 (CC-90010).
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to BMS-986158 or BMS-986378 (CC-90010).
* Uncontrolled intercurrent illness including, but not limited to, ongoing or uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Patients with a known history of HIV, hepatitis B, and/or hepatitis C (testing not required as part of screening).
* Patients with gastrointestinal disease or disorder that could interfere with absorption of BMS-986158 or BMS-986378 (CC-90010), such as bowel obstruction or inflammatory bowel disease.
* For Arm 1: Patients with BSA < 0.3 m2 for all dose levels except Dose Level -2 or -2i for which patients with BSA < 0.71 m2 will be excluded due to dose rounding constraints.
* For Arm 2: Patients with BSA < 0.65 m2.
Sex :
ALL
Ages :
- Minimum Age : 1 Year
- Maximum Age : 21 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT03936465
| 3,530
|
{
"NCT_ID" : "NCT05869721",
"Brief_Title" : "Effects of Yoga on Women with Breast Cancer",
"Official_title" : "Effects of Yoga on Physical Functioning and Sleep Quality of Women with Breast Cancer: a Pilot Randomized Controlled Trial",
"Conditions" : ["Upper Limb Functions", "Sleep Quality", "Upper Limb Muscle Strength", "Shoulder Mobility", "Heart Rate Variability", "Mood", "Health-related Quality of Life"],
"Interventions" : ["Other: Yoga"],
"Location_Countries" : ["Hong Kong"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional Model" : "PARALLEL",
"Masking" : "SINGLE"
}
}
|
#Study Description
Brief Summary
Upper limb complications and sleep disturbances are prevalent, persistent, and serious health problems in women with breast cancer. However, these problems are underrecognized in clinical practice and thus have substantial adverse impacts on the health and quality of life of women with breast cancer. As yoga practices have been shown to improve physical and psychological health in people with cancer, such practices may also alleviate upper limb complications and sleep disturbances in women with breast cancer. However, there are few evidence-based guidelines or protocols to support the integration of yoga therapy into clinical practice for managing the health conditions of women with breast cancer. Therefore, this study aims to investigate the effects of yoga therapy on improving the upper limb functions, sleep quality, and quality of life in women with breast cancer.
Detailed Description
Breast cancer is the most commonly diagnosed cancer worldwide, accounting for 12% of all new cancer cases annually, and there were an estimated 2.3 million new cases worldwide in 2020. Contemporary breast cancer treatments have improved therapeutic outcomes. However, these treatments cause adverse effects; for example, more than half of women with breast cancer experience treatment-related comorbidities.
Over 60% of women with breast cancer have reported experiencing ipsilateral upper limb complications immediately post-treatment and these complications may become chronic or permanent disorders. Upper limb dysfunction is a long-term complication that comprises a complex range of symptoms and disorders, including lymphedema, pain, decreased joint mobility and muscle strength, sensory alterations, and neuropathies. Another prevalent and persistent problem that has been reported is sleep disturbance. According to a recent review, the prevalence of sleep disturbance ranged from 14 to 90% \[pooled estimated 0.4; 95% Confidence Interval (CI) 0.29 to 0.52\], and the persistence rate has been found to be more than 50%. Such side effects may lead to individual suffering and economic burdens, and can compromise the quality of life of women with breast cancer. Thus, the management of treatment-related side effects is an important part of the supportive care of women with breast cancer.
Yoga is based on ancient India philosophy, and emphasizes the integration of postures, breathing, and meditation. This mind-body practice has gained popularity over the last decades and serves as a complementary approach that is commonly used for various health conditions. This safe and trendy exercise holds attractive to female target participants. Yoga combines joint movements and breathing exercises that can help the lungs to expand, resulting in the stretching of muscles and thus increasing lymphatic circulation, which improves upper limb function. Besides, Yoga combines physical activity with mindful elements consisting of breathing and meditative practices. The practice of such mindfulness with the engagement of skeletal muscles represents a holistic approach that may decrease sleep disturbance.
Upper limb complications and sleep disturbances are prevalent, persistent, and serious health problems in women with breast cancer. However, these problems are underrecognized in clinical practice and thus have substantial adverse impacts on the health and quality of life of women with breast cancer. As yoga practices have been shown to improve physical and psychological health in people with cancer, such practices may also alleviate upper limb complications and sleep disturbances in women with breast cancer. However, there are few evidence-based guidelines or protocols to support the integration of yoga therapy into clinical practice for managing the health conditions of women with breast cancer. Therefore, this study aims to investigate the effects of yoga therapy on improving the upper limb functions, sleep quality, and quality of life in women with breast cancer. The research hypothesis of this study were (1) improvements in upper limb functions and sleep quality, could be observed in the experimental group across the assessment time points and (2) the experimental group should have better upper limb performance and sleep parameters than the control group immediately after Yoga intervention and also at the follow up.
#Intervention
- OTHER : Yoga
- The yoga forms are designed from the modified traditional Hatha yoga style consisting of pranayama, asana, meditation with additional relaxation elements. The selected postures will engage core and upper limb muscle and which proposed to strengthen the whole body, increase flexibility of shoulder and limbs, particularly, improve upper limb mobility and functions; also, the progression of the yoga therapy is targeted to reach the variations of postures. The combined relaxation elements reinforced to achieve restoration of the body so as to improve sleep.
|
#Eligibility Criteria:
Inclusion Criteria:
* Aged >=18
* Female
* Normal cognitive function
* Diagnosed with primary breast cancer of stage I-III
* Completed cancer-related treatments (including surgery, radiotherapy, and/or chemotherapy) at least 4 weeks before enrollment except conventional medical care (e.g., hormonal therapy)
Exclusion Criteria:
* Diagnosed with distant metastasis in non-breast body part
* Diagnosed with significant diseases, such as cardiovascular, respiratory, neurological, musculoskeletal (except upper-extremity problems secondary to breast cancer), endocrine, metabolic, and psychological disorders
* Being pregnant
* Prior experiences of practicing yoga
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT05869721
| 23,587
|
{
"NCT_ID" : "NCT00128856",
"Brief_Title" : "Gemcitabine, Doxorubicin and Paclitaxel (GAT) as Neoadjuvant Treatment of Breast Cancer Patients",
"Official_title" : "Phase II Pharmacogenomic and Clinical Trial for the Administration of Gemcitabine-doxorubicin-paclitaxel (GAT) as Neoadjuvant Treatment of Patients With Stage III Breast Cancer",
"Conditions" : ["Breast Cancer"],
"Interventions" : ["Drug: Gemcitabine", "Drug: Adriamycine", "Drug: Paclitaxel"],
"Location_Countries" : ["Spain"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional Model" : "SINGLE_GROUP",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
This is a multicenter, open-label, phase II trial to assess the efficacy of the GAT neoadjuvant regimen in patients with stage III breast cancer.
Detailed Description
2 treatment cycles of chemotherapy (one cycle = 2 weeks) must be administered to each patient before breast surgery.
The required number of patients has been calculated following Simon's method. 43 patients will be enrolled in two phases: first, 29 patients must be enrolled, and at least 2 pathological complete responses obtained. Patients recruitment will continue until 43 patients have been enrolled. Assumptions are that there is a 95% probability to obtain a rate of pathological complete responses of at least 10%.
#Intervention
- DRUG : Gemcitabine
- Other Names :
- Gemzar
- DRUG : Adriamycine
- Other Names :
- doxorubicin
- DRUG : Paclitaxel
- Other Names :
- Taxol
|
#Eligibility Criteria:
Inclusion Criteria:
* Stage III breast cancer disease, with histological confirmation by true-cut or open-biopsy.
* Ages between 18 and 75 years. Patients older than 70 must have an adequate quality of life to be eligible.
* Patients cannot have received previous treatment with chemotherapy, hormone therapy, radiotherapy or immune therapy.
* Performance status of 0,1, 2 Eastern Cooperative Oncology Group (ECOG).
* At least a 6 month life expectancy.
* Neutrophils > 1500; platelets > 100000; haemoglobin > 10 mg/dL.
* Adequate renal and hepatic functions, with serum creatinine < 1.2 mg/dl and total bilirubin < 2 mg/dl.
* Adequate contraceptive methods during the study and up to 3 months after.
* Adequate cardiac function assessed by physical exam, electrocardiogram and left ventricular ejection fraction > 55%.
Exclusion Criteria:
* Inflammatory carcinoma or stage I, II or IV breast cancer disease.
* Males.
* Active infection.
* Other neoplasms except for basal skin carcinoma or cervical in situ carcinoma adequately treated. Other previous neoplasms are allowed if diagnosed and treated more than 5 years before study registration.
* Concomitant serious disease provoking organ failure (heart, renal, hepatic, respiratory).
* Pre-existing motor or sensorial neuropathy > grade 1.
* Inability for treatment compliance.
* History of hypersensitivity to compounds such as cremophor, cyclosporine or vitamin K.
* History of arrhythmias or congestive heart failure, even when controlled; or active cardiac blocking of second or third grade.
* History of myocardial infarction in the previous 6 months.
* Hypertension not controlled.
* Pregnant or lactating women.
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT00128856
| 30,989
|
{
"NCT_ID" : "NCT02206503",
"Brief_Title" : "Cyclophosphamide With Biochemical Progression During Lenalidomide-Dexamethasone Treatment for Relapsed/Refractory Multiple Myeloma (MM)",
"Official_title" : "A PHASE II, MULTI-CENTER, OPEN LABEL STUDY OF CYCLOPHOSPHAMIDE IN MULTIPLE MYELOMA PATIENTS WITH BIOCHEMICAL PROGRESSION DURING LENALIDOMIDE-DEXAMETHASONE TREATMENT FOR RELAPSED/REFRACTORY MULTIPLE MYELOMA",
"Conditions" : ["Multiple Myeloma"],
"Interventions" : ["Drug: Lenalidomide", "Drug: Cyclophosphamide", "Drug: Dexamethasone"],
"Location_Countries" : ["Italy"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional Model" : "SINGLE_GROUP",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
This study evaluates the efficacy of the addiction of Cyclophosphamide to Revlimid-low dose dexamethasone (Rd) in relapsed/refractory Multiple Myeloma patients, who experienced a biochemical progression, without CRAB, during Rd treatment.
Detailed Description
This protocol is a phase II multicenter, open label study designed to determine whether the addiction of Cyclophosphamide to Rd (CRd) treatment significantly increases response rates and prolonged the outcome (PFS, OS) in patients who experienced a biochemical relapse, without CRAB under Rd treatment. Patients will be evaluated at scheduled visits in up to 3 study periods: pre-treatment, treatment and long-term follow-up (LTFU).
The pre-treatment period includes: screening visits, performed at study entry. After providing written informed consent to participate in the study, patients will be evaluated for study eligibility. The screening period includes the availability of inclusion criteria described above. Subjects who meet all the inclusion criteria will be enrolled.
The treatment period includes: administration of the combination CRd for 9 cycles. In order to assess the efficacy and safety of treatment, patients will attend the study center visits at least every 2 weeks. The response will be assessed after each cycle.
During the LTFU period, after development of confirmed progression disease (PD), all patients are to be followed for survival every 1-3 months via telephone or office visit.
#Intervention
- DRUG : Cyclophosphamide
- This protocol is a phase II multicenter, open label study designed to determine whether the addition of Cyclophosphamide to Rd (CRd) treatment significantly increases response rates and prolonged the outcome (PFS, OS) in patients who experienced a biochemical relapse, without CRAB under Rd treatment. The treatment period includes: administration of the combination CRd for 9 cycles. In order to assess the efficacy and safety of treatment, patients will attend the study center visits at least every 2 weeks. The response will be assessed after each cycle. During the LTFU period, after development of confirmed PD, all patients are to be followed for survival every 1-3 months via telephone or office visit.
- DRUG : Lenalidomide
- DRUG : Dexamethasone
|
#Eligibility Criteria:
Inclusion Criteria:
* Patient with relapse/refractory multiple myeloma who experienced biochemical progression, without CRAB, during treatment with Rd. CRAB means the presence of organ damage, multiple myeloma related (renal impairment and/or anemia and/or new bone lesions and/or hypercalcemia). It is sufficient one of the previous signs for defining the presence of CRAB. Biochemical progression means: positivization of serum/urine immunofixation for patients who reached a complete remission with Rd treatment or at least 25% increment of monoclonal component in serum/urine for patients who reached at least a stable disease (SD).
* Patient exposed to previous therapy included Lenalidomide, Thalidomide, Bortezomib and/or autologous stem cell transplantation (ASCT) and in treatment with Rd.
* Patient is, in the investigator(s) opinion, willing and able to comply with the protocol requirements.
* Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
* Female patient is either post-menopausal or surgically sterilized or, if at childbearing potential, must: understand that the study medication could have an expected teratogenic risk.
* Agree to use, and be able to comply with, effective contraception without interruption, 4 weeks before starting study drug, throughout study drug therapy (including dose interruptions) and for 4 weeks after the end of study drug therapy, even if she has amenorrhea. This applies unless the subject commits to absolute and continued abstinence confirmed on a monthly basis. The following are effective methods of contraception*:
* Implant**
* Levonorgestrel-releasing intrauterine system (IUS)**
* Medroxyprogesterone acetate depot
* Tubal sterilisation
* Sexual intercourse with a vasectomised male partner only; vasectomy must be confirmed by two negative semen analyses
* Ovulation inhibitory progesterone-only pills (i.e., desogestrel)
* Combined oral contraceptive pills are not recommended. If a subject was using combined oral contraception, she must switch to one of the methods above. The increased risk of venous thromboembolism (VTE) continues for 4 to 6 weeks after stopping combined oral contraception.
* **prophylactic antibiotics should be considered at the time of insertion particularly in patients with neutropenia due to risk of infection.
* Agree to have a medically supervised pregnancy test with a minimum sensitivity of 25 mills International Units on milliliter (mIU/ml) not more than 3 days before the start of study medication once the subject has been on effective contraception for at least 4 weeks. This requirement also applies to women of childbearing potential who practice complete and continued abstinence.
* Agree to have a medically supervised pregnancy test every 4 weeks including 4 weeks after the end of study treatment, except in the case of confirmed tubal sterilization. These tests should be performed not more than 3 days before the start of next treatment. This requirement also applies to women of childbearing potential who practice complete and continued abstinence.
* † A female subject or a female partner of a male subject is considered to have childbearing potential unless she meets at least one of the following criteria: Age
>=50 years and naturally amenorrhoeic for >= 1 year (amenorrhoea following cancer therapy does not rule out childbearing potential), premature ovarian failure confirmed by a specialist gynaecologist, previous bilateral salpingooophorectomy or hysterectomy, xy genotype, Turner's syndrome or uterine agenesis.
* Male subjects must:
* Agree to use condoms throughout study drug therapy, during any dose interruption and for one week after cessation of study therapy if their partner is of childbearing potential and has no contraception.
* Agree not to donate semen during study drug therapy and for one week after end of study drug therapy.
* All subjects must:
* Agree to abstain from donating blood while taking study drug therapy and for one week following discontinuation of study drug therapy.
* Agree not to share study medication with another person and to return all unused study drug to the investigator.
* Patient who obtain at least a SD with Rd treatment and experienced a biochemical progression without CRAB, during the treatment itself.
* Patient has a Karnofsky performance status >= 60%.
* Patient has a life-expectancy > 6 months.
* Patients must have a adequate cardiac function.
* Patients must have adequate pulmonary function.
* Patient has the following laboratory values within 14 days before Baseline (day 1 of the Cyclophosphamide):
* Platelet count >= 50 x 109/L or >= 25 109/L if bone marrow involvement is >= 50% of plasma cells in bone marrow biopsy.
* Absolute neutrophil count (ANC) >= 1.0 x 109/L or >= 0,5 109/L x if bone marrow involvement is >= 50% of plasma cells in bone marrow biopsy.
* Corrected serum calcium <= 14 mg/dL (3.5 mmol/L).
* Aspartate transaminase (AST): <= 2.5 x the upper limit of normal (ULN).
* Alanine transaminase (ALT): <= 2.5 x the ULN.
* Total bilirubin: <= 1.5 x the ULN.
* Calculated or measured creatinine clearance: >= 30 mL/minute.
Exclusion Criteria:
* Patients with newly diagnosed multiple myeloma.
* Patients who relapsed from multiple myeloma with signs of organ damage related to disease (CRAB).
* Any serious medical condition, including the presence of laboratory abnormalities, which places the subject at an unacceptable risk if he or she participates in this study or confounds the experimental ability to interpret data from the study.
* Pregnant or lactating females.
* Prior history of malignancies, other than multiple myeloma, unless the subject has been free of the disease for >= 3 years. Exceptions include the following: Basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, incidental histological finding of prostate cancer (TNM stage of T1a or T1b).
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT02206503
| 24,242
|
{
"NCT_ID" : "NCT04059588",
"Brief_Title" : "A Study Investigating the Safety and Tolerability of an Immune Treatment in Cancer Patients With Lesions to the Skin",
"Official_title" : "A Phase I, Dose-escalation Study Investigating the Safety and Tolerability of Intratumoral Injection of an Fc-engineered Anti-CD40 Monoclonal Antibody (2141-V11) in Patients With Cancer",
"Conditions" : ["Cancer", "Solid Tumor", "Cancer of Skin"],
"Interventions" : ["Drug: 2141 V-11"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "OTHER",
"Allocation" : "NA",
"Interventional Model" : "SEQUENTIAL",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
The purpose of this study is to test the safety and tolerability of 2141-V11 in people who have cancer that does not respond to standard treatment and who have skin lesions (skin tumors) associated with their cancer. The study will also test how the body processes and responds to 2141-V11, and if the study drug has cancer fighting activity in people. The study drug activates a naturally occurring protein called CD40. By activating CD40, cells of the immune system are better able to identify and kill cancer cells.
We are testing if injection of 2141-V11 into metastasis to the skin will be safe and well tolerated, and may result in immune activation in patients with solid tumors that have metastasis to the skin.
Detailed Description
This is a Phase 1 open label, dose-escalation study evaluating the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and efficacy of the Fc-engineered variant 2141-V11 in patients with previously treated relapsed or refractory solid tumors and locally advanced or metastatic solid tumors to the skin amenable to intratumoral injection.
There are two parts to the study: a dose-finding stage (Part I), and a dose expansion stage (Part II). Both Part I and Part II of the study will include patients with locally advanced or metastatic cancers of the skin which are not amenable to standard treatment.
A traditional 3 + 3 dose escalation design will be used (Part I). Successive cohorts of participants (3 participants/cohort) will be started on a fixed dose intratumoral injection of 2141V11 at the dose assigned to their cohort. The study drug, 2141-V11, will be dosed once every 3 weeks. The study drug is administered in cycles.
The first group of study participants in Part I will receive the lowest dose of study drug. The next group of study participants will receive the next higher dose. This dosing scheme continues until the maximum tolerated dose is determined. The maximum tolerated dose (MTD) will be defined as 1 dose level below the dose in which DLTs are observed in \>33% of the participants.
Participants in Part II of the study will receive the MTD determined from Part 1 (dose escalation) of the study. Part II participants in the study will also receive two vaccinations (KLH and tetanus) to allow monitoring of their immune function.
Participants in both Part I and II can continue to receive cycles of study drug at their assigned dose if they do not experience progression of disease, a serious adverse event, and the study is ongoing.
#Intervention
- DRUG : 2141 V-11
- intratumoral injection of 2141-V11
|
#Eligibility Criteria:
Inclusion Criteria:
* Age > 18 years
* Must have measurable or evaluable metastatic disease (at least more than 1 lesion) as evidenced by physical exam or imaging
* Must have an identifiable metastatic lesion of the skin, subcutaneous tissue, or lymph node amenable to intratumoral injection. This includes all solid tumors as well as metastatic melanoma and/or melanoma with in-transit metastases.
* ECOG performance status < 1
* Histologically confirmed diagnosis of refractory or relapsed metastatic disease
* Required values for screening laboratory tests:
* Absolute neutrophil count (ANC) > 1000/mm3 independent of growth factor support
* Platelets > 75,000/mm3
* Hemoglobin > 8 g/dl
* Creatinine clearance > 40 ml/min for the dose-escalation phase, >25 ml/min in dose expansion phase (if safety data from dose escalation indicate this is possible)
* AST/ALT < 3 x ULN
* Bilirubin < 1.5 x ULN (except for participants with Gilbert's Syndrome or of non-hepatic origin)
* Patients must have refractory or relapsed disease and have must have exhausted all standard-of-care therapy for their disease
* Must be at least 4 weeks since treatment with checkpoint inhibitors or other antibody-based therapy or investigational agents
* Must be at least 2 weeks since chemotherapy, targeted small molecule therapy, cytokine therapy, or radiation therapy, and be recovered from any clinically significant toxicity experienced during treatment.
* If sexually active male or female, and participating in sexual activity that could lead to pregnancy, agrees to use two effective methods of contraception (i.e. condom with spermicide, diaphragm with spermicide, hormone-eluting IUD, hormone-based contraceptive with condom). For females, these restrictions apply for 1 month after the last dose of study drug. For males, these restrictions apply for 3 months after the last dose of study drug. Men must agree not to donate sperm during and after the study.
Female study participants of reproductive potential are defined as pre-menopausal women who have not had a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, tubal ligation or salpingectomy). Women are considered menopausal if they have not had a menses for at least 12 months and have a FSH of greater than 40 IU/L or if FSH testing is not available, they have had amenorrhea for 24 consecutive months.
* Women of childbearing potential must have a negative (beta-human chorionic gonadotropin [b-hCG] pregnancy test at screening, as well as a negative pregnancy test prior to each treatment
* Life expectancy greater than 16 weeks (should be evaluated by a prognostic score, e.g., Royal Marsden score).
* Able to comply with the treatment schedule as determined by the participant and the LIP
Exclusion Criteria:
* Concurrent anticancer therapy including investigational agents. This includes topical therapeutic agents.
* History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia (i.e. bronchiolitis obliterans, cryptogenic organizing pneumonia), risk of pulmonary toxicity, or evidence of active pneumonitis on screening chest CT scan.
* History of radiation pneumonitis in the radiation field (fibrosis) is permitted
* Patients with active hepatitis B (defined as having a positive hepatitis B surface antigen (HBsAg) test at screening.
* Patients with past/resolved hepatitis B virus (HBV) infection (defined as having a negative HBsAg and a positive antibody to hepatitis B core antigen antibody test) are eligible only if polymerase chain reaction is negative for HBV RNA. HBV DNA must be obtained in these patients prior to Cycle 1, Day 1.
* History of stroke or intracranial hemorrhage within 6 months prior to enrollment.
* Has spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for > 2 weeks prior to screening.
* Vaccinated with live, attenuated viral vaccines within 4 weeks of enrollment.
* Known history of human immunodeficiency virus (HIV) or any uncontrolled active systemic infection.
* Major surgery or a wound that has not fully healed within 4 weeks of enrollment.
* Treatment with an immunosuppressive regimen of corticosteroids or other immunosuppressive medication (e.g., methotrexate, rapamycin) within 30 days of study treatment. Note: patients with adrenal insufficiency may take up to 5 mg of prednisone or equivalent daily. Topical and inhaled corticosteroids in standard doses are allowed.
* Severe infections within 4 weeks prior to Cycle 1, Day 1, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia.
* Signs and symptoms of infection within 2 weeks prior to Cycle 1, Day 1.
* Any investigational therapy within 28 days prior to initiation of study treatment. This includes topical or injected agents.
* Significant cardiovascular disease (i.e., NYHA class 3 congestive heart failure; myocardial infarction within the past 6 months; unstable angina; coronary angioplasty within the past 6 months; uncontrolled atrial or ventricular cardiac arrhythmias.
* Autoimmune disease including systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, autoimmune thrombocytopenia, history of uveitis or other autoimmune disease if clinically significant.
* Patients with clinically active brain metastases are excluded. Patients with stable brain metastasis (with or without intervention) are eligible. Patients with previously irradiated lesions are eligible provided patient is >4 weeks beyond completion of cranial irradiation and >3 weeks of corticosteroid therapy.
* Known history of leptomenigeal disease, patients with metastases to the brain stem, midbrain, pons, or medulla, and patients with metastases with 10 mm of the optic apparatus (optic nerve and chiasm) will be excluded from the study.
* Requires anticoagulation with warfarin or equivalent vitamin K antagonists.
* Has had a pulmonary embolism or any other thromboembolic event within 6 months prior to study entry.
* Prior toxicities from previous cancer therapy, including checkpoint inhibition, that have not regressed to Grade < 1 severity (NCI CTCAE v4.03, or later versions) within 28 days before Cycle 1, Day 1, with the exception of alopecia.
* Active hepatitis C are excluded. Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
* Any surgical procedure within less than 14 days of the first receipt of study drug. Major surgical procedure within 28 days prior to Cycle 1, Day 1 or anticipation of the need for a major surgical procedure during the study other than for diagnosis.
* Pregnant or breast feeding
* Active infection or with a fever >38.5o C within 3 days prior to the first scheduled treatment.
* Any medical history, including laboratory results, deemed by the investigator to be likely to interfere with their participation in the study, or to interfere with the interpretation of the results, or any social condition that, in the opinion of the Investigator, might pose additional risk to the participant or confound the results of the study.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT04059588
| 32,820
|
{
"NCT_ID" : "NCT00773448",
"Brief_Title" : "Screening for Occult Malignancy in Patients With Idiopathic Venous Thromboembolism",
"Official_title" : "Screening for Occult Malignancy in Patients With Idiopathic Venous Thromboembolism: an Open Randomized Controlled Trial Using a Comprehensive Abdomen/Pelvis Computed Tomography",
"Conditions" : ["Venous Thromboembolism", "Deep Vein Thrombosis", "Pulmonary Embolism"],
"Interventions" : ["Device: Comprehensive computed tomography of the abdomen/pelvis", "Other: Limited Malignancy Screening"],
"Location_Countries" : ["Canada"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "SCREENING",
"Allocation" : "RANDOMIZED",
"Interventional Model" : "PARALLEL",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
Blood clots in leg veins (deep vein thrombosis) or lung arteries (pulmonary embolism) that happen for no reason (i.e. unexplained) are both called 'unprovoked venous thromboembolism' (VTE). These unexplained blood clots can be the first symptom of cancer. Up to 10% of patients with unexplained blood clots will be diagnosed with cancer within one year of their blood clot diagnosis.
These cancers can be found anywhere in the body although the relationship appears stronger with the pancreas, ovary and liver. Cancer testing in patients with blood clots is controversial. There is presently a wide variety of expert opinions and practices. Previous studies showed that a limited cancer screen including a medical history, physical examination, basic blood work and chest X-ray, will find about 90% of cancers. More recent and better designed studies showed that the limited cancer screen misses many cancers and needs to be improved. More extensive cancer testing may find more cancers but is potentially uncomfortable for patients, costs a lot of money and involves a lot of people.
The 'comprehensive computed tomography' is less uncomfortable, inexpensive, radiological test made to find many cancers at once. Thus, the scientific question to be asked is: Does a 'comprehensive computed tomography' miss less cancers than a limited cancer screen in patients with blood clots?
The main goal of this study is to find out if a 'comprehensive computed tomography' misses less cancers than a limited cancer screen in patients with unexplained blood clots.
The second goal of the study is 1) to find out if a 'comprehensive computed tomography' finds more 'curable' cancers than the limited cancer screen; 2) to find out if the patients diagnosed with cancer are still alive and cancer-free after one year (i.e. the patients with curable cancer were treated and are doing well); 3) to prove that a negative 'comprehensive computed tomography' means that the patient will not have cancer and; 4) to find out if a 'comprehensive computed tomography' is well tolerated and safe for patients.
#Intervention
- DEVICE : Comprehensive computed tomography of the abdomen/pelvis
- Virtual colonoscopy and gastroscopy, a biphasic enhanced CT for hepatoma and renal cell carcinoma, parenchymal pancreatogram with minimum intensity projection (MinIP) reformation for pancreatic carcinoma, and finally uniphasic enhanced CT of distended bladder for bladder and ovarian carcinomas.
- OTHER : Limited Malignancy Screening
- 1) A complete medical history and physical examination; 2) complete blood count; 3) liver function tests (AST, ALT, ALP, bilirubin, LDH); 4) renal function test (creatinine); 5) chest X-ray (if not performed in the past year)
In women, a pap smear/pelvic examination (if \> 18 and \< 70 years old and not performed during the past year),a mammogram (\> 50 years old) will be performed if not conducted in last year. Similarly for men, prostate examination +/- PSA testing (\>40 years old) will be performed if not conducted in the past year.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients with a new diagnosis of unprovoked proximal deep vein thrombosis (DVT) or pulmonary embolism (PE) will be eligible to participate into the study:
* Unprovoked VTE is defined as the absence of any of the following predisposing factors:
1. known active cancer;
2. recent (less than 3 months) paralysis, paresis or plaster immobilization of the lower extremities;
3. recently bedridden for period of 3 or more days, or major surgery, within the previous 12 weeks requiring general or regional anaesthesia;
4. previous unprovoked VTE;
5. known thrombophilia (hereditary or acquired)
* Proximal DVT is defined as a non-compressibility of any vein segment from the common femoral vein to the trifurcation of the popliteal vein or a persistent intra-luminal filling defect of the iliac, common femoral, superficial femoral or popliteal veins on contrast venography.
* Pulmonary embolism is defined as:
1. patients with a high/intermediate pre-test probability (Wells' model > 4) + high probability V/Q scan;
2. positive pulmonary angiogram; or
3. spiral CT demonstrating intraluminal filling defect in a vessel larger than a segmental artery
Exclusion Criteria:
Patients will be excluded from the study if they have any of the following criteria:
* Age < 18 years-old;
* Refusal or inability to provide informed consent;
* Greater than 21 days post diagnosis of idiopathic VTE
* Index VTE event of UEDVT or unusual site DVT
* Diagnosis of SSPE in the absence of above or below knee DVT
* Allergy to contrast media;
* Creatinine clearance < 60 ml/min;
* Claustrophobia or agoraphobia;
* Weight > 130 kg;
* Diagnosis of ulcerative colitis; and
* Diagnosis of glaucoma
* Current pregnancy
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT00773448
| 11,112
|
{
"NCT_ID" : "NCT01558583",
"Brief_Title" : "Online Study of Colorectal Cancer and Prostate Cancer Screening Decision Making",
"Official_title" : "A Comparison of the Effect of a Conjoint Analysis Based Values Clarification Exercise, Rating and Ranking Exercise, and Balance Sheet for Colorectal Cancer Screening and Prostate Cancer Screening Decision Making",
"Conditions" : ["Colorectal Cancer", "Colon Cancer", "Prostate Cancer"],
"Interventions" : ["Other: Rating and Ranking Task", "Other: Balance Sheet Task", "Other: Discrete Choice Task"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "HEALTH_SERVICES_RESEARCH",
"Allocation" : "RANDOMIZED",
"Interventional Model" : "PARALLEL",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
Participants will be recruited from the United States and Australia to take an online survey about colon cancer screening or prostate cancer screening. Individuals selected for both the prostate cancer survey and the colon cancer study will be randomized to take one of three survey types - balance sheet, rating and ranking or conjoint analysis. These surveys will help participants clarify their values and opinions about screening options for colon cancer or prostate cancer. Participants' responses to the online survey are measured at one point in time - the time at which the participant takes the survey.
Detailed Description
This study will compare effect of a conjoint analysis based values clarification exercise, ranking and rating, and a balance sheet on screening test preferences for colorectal cancer screening and prostate cancer screening using online surveys. Recruitment will be conducted through Survey Sampling International (SSI), an online survey research firm. Participants will be randomized to one of three arms to take online surveys. Patients will complete either a conjoint analysis task, in which they will be asked to make a series of choices between hypothetical screening testing strategies with different attributes; a rating and ranking task for these same attributes; or they will make a choice after viewing a balance sheet of attributes.
#Intervention
- OTHER : Rating and Ranking Task
- Individuals who are randomized to the rating and raking arm will be asked to complete an informational task in a rating and ranking format. The task will help individuals clarify their opinions and preferences regarding colon cancer and prostate cancer screening.
- OTHER : Discrete Choice Task
- Individuals who are randomized to the rating and raking arm will be asked to complete an informational task in a discrete choice format. The task will help individuals clarify their opinions and preferences regarding colon cancer and prostate cancer screening.
- OTHER : Balance Sheet Task
- Individuals who are randomized to the rating and raking arm will be asked to complete an informational task in a balance sheet format. The task will help individuals clarify their opinions and preferences regarding colon cancer and prostate cancer screening.
|
#Eligibility Criteria:
Inclusion Criteria:
* Colorectal cancer
* men and women, ages 50 <= age <= 75, who can speak and read English.
* Prostate cancer screening
* men, ages 50 <= age <= 75, who can speak and read English.
Exclusion Criteria:
* Colorectal Cancer
* individuals with a previous personal or family history of colon cancer, personal history of polyps, or inflammatory bowel disease will be excluded.
* Prostate cancer
* individuals with a previous personal or family history of prostate cancer will be excluded
Sex :
ALL
Ages :
- Minimum Age : 50 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
Yes
|
NCT01558583
| 35,137
|
{
"NCT_ID" : "NCT02059954",
"Brief_Title" : "Vaginal vs. Laparoscopic Hysterectomy",
"Official_title" : "Vaginal Hysterectomy Versus Total Laparoscopic Hysterectomy for Benign Indications: A Randomized Controlled Trial",
"Conditions" : ["Uterine Fibroids", "Uterine Leiomyoma", "Abnormal Uterine Bleeding, Unspecified"],
"Interventions" : ["Procedure: Hysterectomy"],
"Location_Countries" : ["Austria"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional Model" : "PARALLEL",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
Hysterectomy for benign indication is one of the most common surgical procedures in women. Numerous reviews and guidelines recommend the vaginal approach for benign hysterectomy, but the proportion of laparoscopic (and robotic) hysterectomies is increasing.
This study will compare a range of clinical and subjective outcomes of vaginal vs. total laparoscopic hysterectomy. Outcomes include operating time, postoperative recovery, return to work as well as cosmesis, quality of life and sexual health.
#Intervention
- PROCEDURE : Hysterectomy
|
#Eligibility Criteria:
Inclusion Criteria:
* benign indication for vaginal hysterectomy (e.g., abnormal uterine bleeding, fibroids, atypical endometrial hyperplasia)
* clinical exam indicates vaginal hysterectomy is feasible
* no major concomitant surgery
* able to complete questionnaires in German
Exclusion Criteria:
* uterine malignancy
* major concomitant surgery (e.g., for incontinence or prolapse)
* clinical exam indicating vaginal hysterectomy not feasible
* contraindication for surgery or laparoscopy
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT02059954
| 37,678
|
{
"NCT_ID" : "NCT02094872",
"Brief_Title" : "Molecularly Targeted Therapy in Treating Patients With BRAF Wild-type Melanoma That is Metastatic",
"Official_title" : "Stand Up to Cancer Consortium Genomics-Enabled Medicine for Melanoma (G.E.M.M.): Using Molecularly-Guided Therapy for Patients With BRAF Wild-Type (BRAFwt) Metastatic Melanoma",
"Conditions" : ["Recurrent Melanoma", "Stage IIIA Melanoma", "Stage IIIB Melanoma", "Stage IIIC Melanoma", "Stage IV Melanoma"],
"Interventions" : ["Procedure: therapeutic procedure", "Other: quality-of-life assessment", "Other: cytology specimen collection procedure", "Drug: MEK 162 therapy or molecularly targeted therapy", "Other: laboratory biomarker analysis"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional Model" : "SINGLE_GROUP",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
This phase II trial studies how well molecularly targeted therapy works in treating patients with melanoma that has spread to other parts of the body. Patients must have received or do not qualify for prior immunotherapy. Targeted therapy is a type of treatment that uses drugs or other substances to identify and attack specific types of cancer cells with less harm to normal cells. Molecularly targeted therapy works by treating patients with substances that kill cancer cells by targeting key molecules involved in cancer cell growth.
Detailed Description
PRIMARY OBJECTIVES:
I. To determine the difference in best overall response rate (BORR) between patients treated with MEK162 following personalized molecularly guided assignment vs. a historical BORR of 7% in this patient population.
SECONDARY OBJECTIVES:
I. To evaluate the safety of performing individualized drug therapy (including novel agents and commercially-available agents) in the context of a personalized medicine clinical trial.
II. To define the difference in progression free survival (PFS) between patients treated with MEK162 following personalized molecularly guided assignment vs. a historical PFS rate of 2 months in this patient population.
III. To continually assess data in real time so as to iteratively refine and standardize a set of statistical and informatics methodologies for matching treatments to the patient's tumor, based on the molecular profile.
OUTLINE:
Patients undergo collection of tissue and blood samples for deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) analysis via sequencing. Based on the results of the DNA and RNA analysis, patients receive molecularly targeted therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 30 days.
#Intervention
- OTHER : cytology specimen collection procedure
- Undergo collection of tissue and blood samples
- Other Names :
- cytologic sampling
- DRUG : MEK 162 therapy or molecularly targeted therapy
- molecularly targeted therapy, MEK 162 therapy
- PROCEDURE : therapeutic procedure
- Other Names :
- Therapeutic Interventions, Therapeutic Method, Therapeutic Technique, Therapy, TX
- OTHER : laboratory biomarker analysis
- Correlative studies
- OTHER : quality-of-life assessment
- Ancillary studies
- Other Names :
- quality of life assessment
|
#Eligibility Criteria:
Inclusion Criteria:
* Patient with metastatic or locally advanced and unresectable BRAF wild-type melanoma who have either progressed following previous treatment of immunotherapy, or are not eligible for immunotherapy; pts. are defined as 'BRAF wild-type' if they test negative for V600 mutations based on a Clinical Laboratory Improvement Amendments (CLIA) certified assay
* Patients must have tumor accessible by interventional radiology or surgical intervention and suitable for biopsy (BX) with 5 <= age <= 6 passes of a 16 or 18 gauge needle for core BX (defined as at least 1 cm^3 tumor/50 mg accessible for BX), and must agree to undergo up to two surgical resections/biopsies to collect tumor for research purposes; the first of these biopsies will occur at the beginning of the study, prior to genetic analysis and Rx; the second BX will be performed at the time of DZ progression/end of study should funding be available
* Patients must have measurable DZ (per Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1 [v1.1] criteria), defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or a subcutaneous or superficial lesion that can be measured with calipers by clinical exam; for lymph nodes, the short axis must be >= 15 mm
* Previous therapies: prior radiation therapies, immunotherapies, and investigational therapies are allowed as follows.
* Radiation: prior radiation therapy (RT) is allowed with the following conditions:
* Patients who have received minimal RT (=< 5% of their total marrow volume) must have completed it >= 2 weeks prior to the initiation of study Rx
* Patients who have received RT that constituted > 5% but < 50% of their total marrow volume must have completed it >= 4 weeks prior to the initiation of study treatment
* Patients who have received prior radiation to 50% or more of their total marrow volume will be excluded
* Patients may be biopsied while undergoing RT as long as BX site is not in the radiation portal; however, they still have to wait the required amount of time from radiation to treatment even though the tumor board may have already occurred and a treatment plan assigned
* Other therapies: prior investigational or targeted therapies and immunotherapies may be allowed following discussion with the PI (PI); if the PI deems the prior treatment acceptable, patients must not have received these therapies for 28 days or five half-lives of the drug (whichever is lesser) prior to the initiation of study treatment and must have full recovery from any acute effects of these therapies; prior therapy with mitogen-activated protein kinase (MEK) inhibitors will not be allowed
* Patients with chronic grade 2 toxicity may be eligible at the discretion of the PI if the condition has been stable, and not worsening, for at least 30 days; pts. with ongoing alopecia of any grade will be eligible
* Patient must have a life expectancy of >= 3 months, as estimated by the treating oncologist
* Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status =< 2
* Hemoglobin >= 9 g/dL
* Leukocytes >= 3,000/microliter (mcL)
* Absolute neutrophil count (ANC) >= 1,500/mcL
* Platelets (PLT) >= 100,000/mcL
* Aspartate aminotransferase (AST) =< 2.5 x upper limit of normal (ULN); if liver metastases are present, =< 5 x ULN
* Alanine aminotransferase (ALT) =< 2.5 x ULN; if liver metastases are present, =< 5 x ULN
* Bilirubin =< 1.5 x ULN
* Creatinine =< 1.5 x ULN OR calculated or measured creatinine clearance >= 50 mL/min/1.73 m^2 for pts. with creatinine above institutional normal
* If available, pt. must agree to provide archival tissue for research purposes (either archival paraffin tissue block or 10 unstained slides of a primary or metastatic melanoma lesion) prior to enrollment; samples should be shipped within 1 month after enrollment
* Patient agrees to having a blood sample (a minimum of 10 mL, with 20 mL preferred) drawn and analyzed to compare their normal genetic profile to that of their tumor sample
* Patient must be able to tolerate oral medication
* Women of child-bearing potential and men must agree to use 2 forms of adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation, and for four months following completion of study therapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; women who become pregnant must immediately discontinue Rx with any study therapy; male pts. should avoid impregnating a female partner; male pts., even if surgically sterilized, (i.e. post-vasectomy) must agree to one of the following: practice effective barrier contraception during the entire study Rx period and through 4 months after the last dose of study drug, or completely abstain from sexual intercourse
* Patient must have the ability to understand and the willingness to sign a written informed consent document
* Patient must be willing and able to comply with the protocol for the duration of the study, including attending scheduled visits, examinations, the BX procedure, and having their tumor and blood molecularly characterized
* Patient understands they must meet all inclusion and exclusion criteria in the drug specific appendix for which they were assigned.
Exclusion Criteria:
* Patients with peripheral neuropathy >= grade 2 are not permitted unless discussed with the PI and only in unique circumstances (i.e. unilateral neuropathy due to trauma)
* Patient has DZ that tests positive for BRAF V600 mutations based on the results of a CLIA certified assay
* Patients with active infection at time of BX
* Patients with any evidence of severe or uncontrolled systemic DZ(s) including known cases of hepatitis B or C or human immunodeficiency virus (HIV); screening for chronic conditions is not required, although pts. known to have such conditions at screening should not be included
* Any patient requiring chronic maintenance of red blood cell, white blood cell or granulocyte counts through the use of blood transfusions or growth factor support (e.g. Neulasta®, Neupogen®)
* Patients with a prior history of seizures within the past year unrelated to brain metastases
* Patients with known active progressive brain metastases; pts. with prior treated brain metastases are allowed, providing that they were not accompanied by seizures within the past year and that a baseline brain MRI scan prior to study entry demonstrates no current evidence of active brain metastases; all pts. with prior treated brain metastases must be stable for > 1 months after treatment and off steroid treatment prior to study enrollment
* Patients receiving any other anti-cancer therapy (cytotoxic, biologic, radiation, or hormonal other than for replacement) except for medications that are prescribed for supportive care but may potentially have an anti-cancer effect (i.e. megestrol acetate, bisphosphonates); these medications must have been started >= month prior to enrollment on this study; pts. may be on low molecular weight heparin or direct factor Xa inhibitors
* Patients with any clinically significant medical condition which, in the opinion of the investigator, makes it undesirable for the pt. to participate in the study or which could jeopardize compliance with protocol requirements including, but not limited to: ongoing or active infection, significant uncontrolled hypertension, or severe psychiatric illness/social situations
* Patients with preexisting cardiac conditions, including uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure will not be eligible
* Patients with left ventricular ejection fraction (LVEF) < 45% will not be eligible
* Patients with either of the following within 6 months before the first dose of study treatment:
* Stroke (including transient ischemic attack [TIA], or other ischemic event)
* Myocardial infarction
* Patients with acute gastrointestinal bleeding within 1 month of study entry
* Patients who have, at screening, corrected QT interval using Fridericia's formula (QTcF) >= 450 msec for males and QTcF >= 470 for females
* Patients with a co-morbid condition(s) that, in the opinion of the investigator, prevents safe surgery/BX procedure
* Patients with malabsorption syndrome or other condition that would interfere with intestinal absorption or ability to swallow oral medication
* Pregnant or nursing women; breastfeeding must be discontinued prior to Rx
* Patients who have received organ transplant
* Patients who have had major surgery within 14 days of study enrollment
* Patients diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, or an in situ malignancy. Patients with a low grade prostate cancer, not on hormonal therapy, for which the disease is confined to the prostate may be considered eligible by the overall Principal Investigator on a case by case basis.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT02094872
| 8,229
|
{
"NCT_ID" : "NCT02182687",
"Brief_Title" : "Stereotactic Body Radiation Therapy (SBRT) Versus Trans-Arterial Chemoembolization (TACE) as Bridge to Liver Transplant",
"Official_title" : "A Randomized Phase II Study of Individualized Stereotactic Body Radiation Therapy (SBRT) Versus Trans-Arterial Chemoembolization (TACE) With DEBDOX Beads as a Bridge to Transplant in Hepatocellular Carcinoma.",
"Conditions" : ["Hepatocellular Carcinoma", "HCC"],
"Interventions" : ["Radiation: Stereotactic Body Radiation Therapy (SBRT)", "Procedure: Trans-Arterial Chemoembolization (TACE)", "Drug: Doxorubin"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional Model" : "PARALLEL",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
This study will compare stereotactic body radiation therapy (SBRT) to trans-arterial chemoembolization (TACE) as a bridging strategy for patients with HCC undergoing orthotopic liver transplantation. We propose that SBRT will be associated with longer time intervals between initial treatment and the need for retreatment, compared to TACE, as a 'bridge' to orthotopic liver transplantation.
Detailed Description
For patients with hepatocellular carcinoma (HCC) who are waiting for a liver transplant, local treatment of their disease has become the standard of care in an effort to decrease dropout rates and as a means of reducing tumor recurrence after transplantation. However, the best modality for patients undergoing treatment as a bridge to transplantation is unclear. This study will compare stereotactic body radiation therapy (SBRT) to trans-arterial chemoembolization (TACE) as a bridging strategy for patients with HCC undergoing orthotopic liver transplantation. We propose that SBRT will be associated with longer time intervals between initial treatment and the need for retreatment, compared to TACE, as a 'bridge' to orthotopic liver transplantation.
#Intervention
- RADIATION : Stereotactic Body Radiation Therapy (SBRT)
- SBRT will be delivered in five total fractions, with at a minimum of one day between any two treatments. The entire treatment must be delivered within 15 total days.
- Other Names :
- Radiation Therapy
- PROCEDURE : Trans-Arterial Chemoembolization (TACE)
- First day will be administered and a second TACE will be administered after 4 weeks and subsequently if imaging is showing disease progression. Following each TACE procedure all patients will remain in hospital for observation.
- Other Names :
- Chemoembolization
- DRUG : Doxorubin
- This procedure will be completed with 2 vials of drug eluting beads each loaded with 50 mg of Doxorubin.
- Other Names :
- Doxorubin bead therapy
|
#Eligibility Criteria:
Inclusion Criteria
* Patients with hepatocellular carcinoma are eligible for this trial.
Hepatocellular carcinoma is defined as having at least one of the following:
Biopsy proven hepatocellular carcinoma (HCC); or A discrete hepatic tumor(s) as defined by the Barcelona (29) criteria for cirrhotic patients, >2cm with arterial hypervascularity and venous or delayed phase washout on CT or MRI.
* Patient is within Milan Criteria and 'listed' for orthotopic liver transplantation.
* Patients must have a Zubrod performance status of <=2.
* Patients must have a life expectancy of at least 12 weeks.
* Patients must be 18 years or older. Adult patients of all ages, both sexes and all races will be included in this study.
* Patients must be Child-Turcotte-Pugh (CTP) Class A or Class B (<= 7).
* Female patients within reproductive years may not be, nor become, pregnant during participation in this study. Both male and female patients within reproductive years must agree to use an effective contraceptive method during treatment. Women of childbearing age will be required to undergo a urine or serum pregnancy test to ensure they are not pregnant.
* Patients must have adequate organ function within 2 weeks of enrollment. Bone marrow: Platelets >=30,000/mm3 Renal: BUN <=40 mg/dl; creatinine <=2.0 mg/dl Hepatic: INR <= 1.5 or correctable by Vitamin K, unless anti- coagulated for another medical reason Bilirubin < 3 mg/dl (in the absence of obstruction or pre-existing disease of the biliary tract, e.g. primary sclerosing cholangitis) Patients uninvolved liver volume will be estimated and must be > 700ml.
* Patients must sign an informed consent form approved for this purpose by the Institutional Review Board (IRB) of the Lahey Hospital and Medical Center indicating that they are aware of the investigational aspects of the treatment and the potential risks.
Exclusion Criteria
* Patients in a 'special category' designated the Public Health Service, including patients younger than 18, pregnant women, and prisoners.
* Refractory ascites or ascites that requires paracentesis for management.
* Patients with a solitary lesion greater than 5.0cm in size or more than 2 discrete lesions the largest greater than 3.0 cm in size.
* Known allergy to intravenous iodinated contrast agents unresponsive to prednisone pre-treatment.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT02182687
| 36,718
|
{
"NCT_ID" : "NCT03105765",
"Brief_Title" : "Acute and Chronic Pain, Especially Neuropathic Pain, After Thoracotomy and Continuous Application of Ketamine.",
"Official_title" : "Effects of Prophylactic Administration of Ketamine on Acute and Chronic Pain After Thoracotomy for Lung Cancer, a Double Blind Randomised Trial.",
"Conditions" : ["Acute Pain", "Chronic Pain", "Neuropathic Pain"],
"Interventions" : ["Drug: Placebo", "Drug: Ketamine"],
"Location_Countries" : ["Germany"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "PREVENTION",
"Allocation" : "RANDOMIZED",
"Interventional Model" : "PARALLEL",
"Masking" : "QUADRUPLE"
}
}
|
#Study Description
Brief Summary
Chronic Pain, especially neuropathic pain, are adverse events after posterolateral thoracotomy for lung resection. The continuous application of ketamine may have a prophylactic effect and helps to prevent chronic pain. The investigators record the incidence and severity of acute pain and neuropathic pain during a seven day period after thoracotomy as well as the incidence of chronic pain and neuropathic pain after one and three month period. Parallel Group design, comparing one Group with a continuous application (24 hours) of ketamine against a Placebo Group.
#Intervention
- DRUG : Placebo
- Normal saline applied by bolus before operation started, followed by a continuous application of normal saline for 24 hours.
- DRUG : Ketamine
- Application of Ketamine 0,2mg/kg ideal Body weight by Bolus before the Operation started, followed by application of 0,2 mg/kg ideal Body weight for 24 hours.
|
#Eligibility Criteria:
Inclusion Criteria:
* posterolateral thoracotomy for lung parenchyma resection
* informed consent
* ASA (American Society of Anesthesiologists) Status I-III
Exclusion Criteria:
* history of chronic pain
* history of neuropathic pain
* pregnancy or breastfeeding
* participation in another trial
* hypersensitivity for ketamine
* medication with can influence neuropathic pain (gabapentin, clonazepam)
* history of neurological or behavioral illness
* history of alcohol abuse
* history of chemotherapy or radiation
* opioid medication
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT03105765
| 25,298
|
{
"NCT_ID" : "NCT02252913",
"Brief_Title" : "A Study of Safety and Pharmacokinetics of Volitinib With Docetaxel in Patients With Advanced Gastric Cancer",
"Official_title" : "A Phase Ib, Open-label Study of Safety and Pharmacokinetics of Volitinib in Combination With Docetaxel in Patients With Advanced Gastric Cancer",
"Conditions" : ["Gastric Cancer"],
"Interventions" : ["Drug: Volitinib", "Drug: Docetaxel"],
"Location_Countries" : ["China"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Allocation" : "NA",
"Interventional Model" : "SINGLE_GROUP",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of volitinib in combination with docetaxel in patients with locally advanced or metastatic gastric cancer and to determine the Maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) of volitinib in combination with docetaxel.
Detailed Description
This is a phase Ib, open-label study.
There are two stages to this study: a dose-escalation stage and a dose-expansion stage. Approximately 40-50 patients will be enrolled in this two-stage study, about 12-18 patients in the dose-escalation stage and approximately 30 patients in the dose-expansion stage.
Dose escalation stage
Gastric cancer patients who failed the first line therapy (no matter the cMet status) who meet the eligibility criteria will be enrolled into this stage.
Cohort 1: Volitinib 600mg QD + docetaxel 75mg/m2 Cohort 2: Volitinib 800mg QD+ docetaxel 75mg/m2 The conventional 3+3 design (3 patients per dose cohort, with the potential to add additional 3 patients to the same cohort to further evaluate toxicity) will be applied for dose escalation and MTD or RP2D determination. Each treatment cycle will be composed of 3 weeks or 21 days. Dose escalation and entry of the next cohort will occur only after acceptable tolerance has been demonstrated throughout the entire Cycle1.
Dose expansion Stage
Additional patients will be enrolled at the MTD or RP2D to further refine the safety, tolerability, PK, and efficacy at this dose. Patients will be limited to the metastatic / locally advanced gastric cancer patients who failed the first therapy and with positive cMet test results. Patients will be divided into two treatment groups according their c-Met test results:
Group A: FISH + , IHC -/+(about 15 patients) Group B: IHC+ and FISH- (about 15 patients)
#Intervention
- DRUG : Volitinib
- oral administration
- Other Names :
- HMPL-504
- DRUG : Docetaxel
- intravenous injection
- Other Names :
- Taxotere
|
#Eligibility Criteria:
Inclusion Criteria:
* Signed Informed Consent Form
* Age >=18 years
* Histologically or cytologically documented, locally advanced, or metastatic gastric cancer patients who have failed the first line platinum and fluoropyrimidine based treatment. Adjuvant or neoadjuvant chemotherapy will be considered as first line treatment for advanced disease if disease progression occurred during or within 6 months of treatment.
* In the dose expansion stage, patients must have positive cMet test results by a central laboratory
* Absolute neutrophil count (ANC) >= 1.5x109/L, hemoglobin >= 9 g/dL and platelet count >= 100x109/L
* Total bilirubin <=ULN; SGOT (AST), SGPT (ALT), <= 1.5xULN; alkaline phosphatase (ALP) <= 2.5xULN
* Serum creatinine <1.5xULN or creatinine clearance >=50mls/minute; confirmation of creatinine clearance is only required when creatinine is >1.5 ULN
* International normalized ratio (INR) <=1.5xthe ULN or activated partial thromboplastin time (aPTT) <=1.5xthe ULN. The INR applies only to patients who do not receive therapeutic anti-coagulation.
* Evaluable disease at dose escalation stage and measurable disease at dose expansion stage per RECIST v1.1
* ECOG performance status of 0, or 1
* Expected survival > 3 months
* Male or female patients of child-producing potential must agree to double barrier contraception, condoms, intrauterine device (IUD), or contraceptives or other effective avoidance of pregnancy measures during the study and for 90 days after the last dose of treatment
* Female patients of child-producing potential must have a negative pregnancy test prior to start of dosing or must have evidence of non-childbearing potential by fulfilling one of the following criteria at screening:
* Post-menopausal defined as aged more than 50 years and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments
* Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation
* Women under the age of 50 years would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatments and with LH and FSH levels in the post-menopausal range for the institution.
* Patients with known tumor thrombus or deep vein thrombosis (DVT) are eligible if stable on low molecular weight heparin (LMWH) for >=4 weeks.
Exclusion Criteria:
* Prior taxane or cMet inhibitor therapy for advanced disease. Prior taxane containing regimen as adjuvant or neoadjuvant therapy can be allowed provided relapse occurred at least 6 months after therapy
* Co-existing malignancy or malignancies diagnosed within the last 3 years other than Gastric with the exception of skin basal cell carcinoma or cervical cancer in situ at dose expansion stage.
* Any anti-cancer therapy, including, but not limited to chemotherapy, hormonal therapy, target therapy, immunotherapy, biologic therapy, radiotherapy, or herbal therapy within 3 weeks prior to initiation of study treatment with the following exceptions:
* Hormone-replacement therapy or oral contraceptives
* Palliative radiation to bone metastases 2 weeks prior to Day 1
* Strong inducers or inhibitors of CYP3A4 or strong inhibitors of CYP1A2 within 2 weeks before the first dose of study treatment (3 weeks for St John's Wort). See appendix 5
* Adverse events from prior anti-cancer therapy that have not resolved to CTC AE Grade 1, except for alopecia
* Clinically significant active infection
* Known clinically significant history of liver disease, including viral or other hepatitis , current alcohol abuse, or cirrhosis
* Known human immunodeficiency virus（HIV）infection
* Pregnant or lactating women
* NYHA Class II or greater congestive heart failure
* History of myocardial infarction, unstable angina, stroke or transient ischemic attack within 6 months prior to study entry , or cardiac ventricular arrhythmias requiring medication
* Currently receiving treatment with therapeutic doses of warfarin sodium. Low molecular weight heparin (LMWH) is allowed
* Brain metastasis or spinal cord compression not definitively treated with surgery and/or radiation, or previously treated CNS metastases or spinal cord compression without evidence of stable disease (clinically stable imaging) for >= 14 days. Current leptomeningeal metastases.
* Inability to take oral medication, prior surgical procedures (except prior total or partial gastrectomy) or serious gastrointestinal disorders such as dysphagia and active peptic ulcer disease that may affect drug absorption in the opinion of the investigator
* Inability to comply with study and follow-up procedures
* Known hypersensitivity to taxanes, and/or any components of Volitinib tablet or docetaxel formulation components (eg, polysorbate 80).
* More than grade 2 peripheral neuropathy or grade 2 peripheral neuropathy with pain.
* Any other diseases, metabolic dysfunction, physical examination findings, or clinical laboratory finding that, in the investigator's opinion, may give reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or may render the patient at high risk from treatment complications.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT02252913
| 26,763
|
{
"NCT_ID" : "NCT04434508",
"Brief_Title" : "Open Versus Laparoscopic Right Hemicolectomy for Right Colon Cancer",
"Official_title" : "Open Versus Laparoscopic Right Hemicolectomy With Complete Mesocolic Excision and Central Vascular Ligation for Right Colon Cancer. A Randomized Prospective Study.",
"Conditions" : ["Colonic Cancer"],
"Interventions" : ["Procedure: laparoscopic right hemicolectomy with CME and central v", "Procedure: Open right hemicolectomy with CME and central v"],
"Location_Countries" : ["Egypt"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional Model" : "PARALLEL",
"Masking" : "SINGLE"
}
}
|
#Study Description
Brief Summary
The aim of this study is to demonstrate the feasibility, surgical, and oncologic outcomes of laparoscopic right hemicolectomy with CME and CVL compared to open surgery.
Detailed Description
The aim of this study is to demonstrate the feasibility, surgical, and oncologic outcomes of laparoscopic right hemicolectomy with CME and CVL compared to open surgery.
Enrolled patients in the study were randomized to either laparoscopic or open right hemicolectomy with CME and central vascular ligation. The randomization process was performed using a closed envelope method which was withdrawn in the outpatient clinic by a nurse.
The primary outcome was the number of lymph nodes (LNs) harvested among both groups. Secondary outcomes included operative time, blood loss, postoperative complications, and hospital stay.
#Intervention
- PROCEDURE : laparoscopic right hemicolectomy with CME and central v
- laparoscopic right hemicolectomy with CME and central v
- Other Names :
- LHC with CME
- PROCEDURE : Open right hemicolectomy with CME and central v
- Open right hemicolectomy with CME and central v
- Other Names :
- ORH with CME
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients with right colonic cancer
Exclusion Criteria:
* Patients with distant metastasis, large tumors with extra-colonic invasion emergency presentation (bowel obstruction or perforation)
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT04434508
| 22,470
|
{
"NCT_ID" : "NCT01344304",
"Brief_Title" : "Study of Aprepitant / Fosaprepitant for the Prevention of Chemotherapy-induced Nausea and Vomiting (CINV) in Colorectal Cancer Patients - SENRI Trial",
"Official_title" : "Multicenter Randomized Controlled Trial of Combination Antiemetic Therapy With Aprepitant / Fosaprepitant in Patients With Colorectal Cancer Receiving Oxaliplatin-based Chemotherapy",
"Conditions" : ["Colorectal Cancer"],
"Interventions" : ["Drug: Aprepitant / Fosaprepitant"],
"Location_Countries" : ["Japan"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "PREVENTION",
"Allocation" : "RANDOMIZED",
"Interventional Model" : "PARALLEL",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
The object of this study is to evaluate the superiority of aprepitant therapy with a 5HT3-receptor antagonist, dexamethasone and aprepitant compared to standard therapy with a 5HT3-receptor antagonist and dexamethasone for prevention of nausea and vomiting in first course chemotherapy.
#Intervention
- DRUG : Aprepitant / Fosaprepitant
- Aprepitant:
125 mg PO on day 1 80 mg PO on days 2 to 3
Fosaprepitant:
150 mg IV on day 1
|
#Eligibility Criteria:
Inclusion Criteria:
* Age: >=20 years
* Sex: Not specified
* Patients with colon/rectal cancer who first underwent FOLFOX, XELOX or SOX regimen including oxaliplatin at >=85 mg/m2 (naive patient), or those who had already started chemotherapy and had nausea of Grade 2 or higher in the last course or an earlier course (non-naive patient).
* Stage: not specified (neoadjuvant/adjuvant chemotherapy, advanced or recurrent type are allowed)
* Combination of molecular targeted therapy: allowable
* Written informed consent for participation in the study.
Exclusion Criteria:
* Severe liver or kidney disease
* Nausea/vomiting within 24 hr prior to chemotherapy.
* Treatment with antiemetics within 24 hr prior to chemotherapy.
* Presence of factors causing nausea/vomiting other than chemotherapy (e.g. brain tumor, gastrointestinal obstruction, active peptic ulcer disease, brain metastasis)
* Presence of a disease precluding 3-day administration of dexamethasone (e.g. uncontrollable diabetes)
* Pregnant or lactating women, women who plan to become pregnant.
* Current treatment with pimozide.
* Any patient judged to be inappropriate for the study by the investigator.
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT01344304
| 8,261
|
{
"NCT_ID" : "NCT00301457",
"Brief_Title" : "Different Durations of Adjuvant Anastrozole Therapy After 2 to 3 Years Tamoxifen Therapy in Breast Cancer",
"Official_title" : "A Prospective Randomised, Open, Multicentre, Phase III Study to Assess Different Durations of Anastrozole Therapy After 2 to 3 Years Tamoxifen as Adjuvant Therapy in Postmenopausal Women With Breast Cancer.",
"Conditions" : ["Breast Cancer"],
"Interventions" : ["Drug: Anastrozole"],
"Location_Countries" : ["Netherlands"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE3"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional Model" : "PARALLEL",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
The purpose of this study is to determine whether 6 years adjuvant anastrozole will improve the disease free survival compared to 3 years adjuvant anastrozole in postmenopausal hormone sensitive breast cancer patients, subsequent to 2-3 years tamoxifen
#Intervention
- DRUG : Anastrozole
- 1 mg once daily oral dose
- Other Names :
- ARIMIDEX, ZD1033
|
#Eligibility Criteria:
Inclusion Criteria:
* postmenopausal patients with hormone receptor positive breast cancer who have already received 2 <= age <= 3 of adjuvant tamoxifen, and who never had signs of loco-regional recurrences or distant metastasis
Exclusion Criteria:
* Previous hormonal therapy as adjuvant breast cancer treatment besides tamoxifen.
* Previous history of invasive breast cancer within the last 10 years, other then the breast cancer that is currently treated with tamoxifen
Sex :
FEMALE
Ages :
- Minimum Age : 45 Years
- Maximum Age : 99 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT00301457
| 6,508
|
{
"NCT_ID" : "NCT01504126",
"Brief_Title" : "Propranolol Hydrochloride and Chemotherapy in Treating Patients With Ovarian, Primary Peritoneal, or Fallopian Tube Cancer",
"Official_title" : "Feasibility Study: Therapeutic Targeting of Stress Factors in Ovarian Cancer Patients",
"Conditions" : ["Fallopian Tube Clear Cell Adenocarcinoma", "Fallopian Tube Endometrioid Adenocarcinoma", "Fallopian Tube Mucinous Adenocarcinoma", "Fallopian Tube Serous Adenocarcinoma", "Fallopian Tube Undifferentiated Carcinoma", "Ovarian Clear Cell Adenocarcinoma", "Ovarian Endometrioid Adenocarcinoma", "Ovarian Mucinous Adenocarcinoma", "Ovarian Seromucinous Carcinoma", "Ovarian Serous Adenocarcinoma", "Ovarian Undifferentiated Carcinoma", "Primary Peritoneal Serous Adenocarcinoma", "Stage II Fallopian Tube Cancer AJCC v6 and v7", "Stage II Ovarian Cancer AJCC v6 and v7", "Stage IIA Fallopian Tube Cancer AJCC v6 and v7", "Stage IIA Ovarian Cancer AJCC V6 and v7", "Stage IIB Fallopian Tube Cancer AJCC v6 and v7", "Stage IIB Ovarian Cancer AJCC v6 and v7", "Stage IIC Fallopian Tube Cancer AJCC v6 and v7", "Stage IIC Ovarian Cancer AJCC v6 and v7", "Stage III Fallopian Tube Cancer AJCC v7", "Stage III Ovarian Cancer AJCC v6 and v7", "Stage III Primary Peritoneal Cancer AJCC v7", "Stage IIIA Fallopian Tube Cancer AJCC v7", "Stage IIIA Ovarian Cancer AJCC v6 and v7", "Stage IIIA Primary Peritoneal Cancer AJCC v7", "Stage IIIB Fallopian Tube Cancer AJCC v7", "Stage IIIB Ovarian Cancer AJCC v6 and v7", "Stage IIIB Primary Peritoneal Cancer AJCC v7", "Stage IIIC Fallopian Tube Cancer AJCC v7", "Stage IIIC Ovarian Cancer AJCC v6 and v7", "Stage IIIC Primary Peritoneal Cancer AJCC v7", "Stage IV Fallopian Tube Cancer AJCC v6 and v7", "Stage IV Ovarian Cancer AJCC v6 and v7", "Stage IV Primary Peritoneal Cancer AJCC v7"],
"Interventions" : ["Procedure: Therapeutic Conventional Surgery", "Drug: Chemotherapy", "Drug: Propranolol Hydrochloride", "Other: Quality-of-Life Assessment"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["EARLY_PHASE1"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional Model" : "SINGLE_GROUP",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
This early phase I trial studies giving propranolol hydrochloride with standard chemotherapy in treating patients with ovarian, primary peritoneal, or fallopian tube cancer. Biological therapies, such as propranolol hydrochloride, blocks certain chemicals that affect the heart and this may stimulate the immune system and allow the chemotherapy to kill more tumor cells.
Detailed Description
PRIMARY OBJECTIVES:
I. To determine the feasibility of pharmacologic beta-adrenergic blockade in women with stages II-IV epithelial ovarian cancer patients (n=25) either during initial tumor reductive surgery and through the first six cycles of standard intravenous chemotherapy or during neoadjuvant chemotherapy followed by surgery and further chemotherapy (chemo) up to a total of 6 cycles.
SECONDARY OBJECTIVES:
I. To characterize the biobehavioral states of these patients by using the Functional Assessment of Chronic Illness and Therapy- Ovary (FACT-O), Hospital Anxiety and Depression Survey (HADS) and the Center for Epidemiologic Studies Depression Scale (CESD) and serum levels of angiogenic cytokines at points pre- and post-treatment with beta-blockers.
II. To follow patients for progression-free survival (PFS) and overall survival (OS).
TRANSLATIONAL OBJECTIVES:
I. Determining vascular endothelial growth factor (VEGF), interleukin (IL)-6, IL-8, and other cytokines levels in patients with ovarian cancer who are receiving beta-blockers and comparing these levels pre-treatment and during treatment with response.
OUTLINE:
Patients receive propranolol hydrochloride orally (PO) twice daily (BID) beginning 48-72 hours before treatment. Patients undergoing surgery resume propranolol hydrochloride post-operatively once oral drugs are tolerated and continue until completion of 6 cycles of chemotherapy. Patients undergoing neoadjuvant chemotherapy continue propranolol hydrochloride PO BID during 3 chemotherapy cycles pre-surgery and 3 cycles post-surgery. Treatment repeats every 3 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 1 year.
#Intervention
- DRUG : Chemotherapy
- Undergo standard chemotherapy
- Other Names :
- Chemo, Chemotherapy (NOS), Chemotherapy, Cancer, General
- DRUG : Propranolol Hydrochloride
- Given PO
- Other Names :
- Inderal, Innopran XL
- OTHER : Quality-of-Life Assessment
- Ancillary studies
- Other Names :
- Quality of Life Assessment
- PROCEDURE : Therapeutic Conventional Surgery
- Undergo surgical resection
|
#Eligibility Criteria:
Inclusion Criteria:
* Suspected preoperative diagnosis of invasive epithelial ovarian cancer, primary peritoneal carcinoma, fallopian tube cancer based on imaging and cancer antigen (Ca) 125; histologic epithelial cell types are eligible: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell carcinoma, mixed epithelial carcinoma, or adenocarcinoma not otherwise specified; patients with primarily carcinoma histology but mixed features can be included; the surgically confirmed histologic features must be compatible with primary Mullerian epithelial adenocarcinoma
* Stages II-IV of the above cancer
* Patients to be scheduled for a planned tumor debulking
* Intention for chemotherapy administration at MD Anderson Cancer Center
* Zubrod performance status 0 <= age <= 2
* Absolute neutrophil count (ANC) >= 1500/ml
* Platelets > 100,000/mL
* Creatinine clearance (CrCl) > 50 mL/min
* Bilirubin =< 1.5 x institutional upper limit normal
* Serum glutamic oxaloacetic transaminase (SGOT) =< 2.5 x institutional upper limit normal
* Alkaline phosphatase =< 2.5 x institutional upper limit normal
* Neuropathy (sensory and motor) =< grade 1 according to Common Toxicity Criteria for Adverse Events version 3 (CTCAE)
* Prothrombin time (PT) such that international normalized ratio (INR) is =< 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin for the management of venous thrombosis including pulmonary embolus)
* Partial thromboplastin time (PTT) < 1.2 times institutional upper limit of normal
* Pulse >= 60 beat per minute (bpm)
* Systolic blood pressure (SBP) > 110 mmHg; diastolic blood pressure (DBP) >= 60 mmHg
* Normotensive individuals not already on beta blockers (may be on other anti hypertensives): SBP =< 140, DBP =< 90
* Surgery or neoadjuvant chemotherapy must be scheduled at least 72 hours in advance in order for the patient to take at least 48 hours of prescribed propranolol and have stable vital signs confirmed
* An approved informed consent and authorization permitting release of personal health information must be signed by patient or guardian
* Patients of childbearing age must have a negative pregnancy test
* Patients who receive neoadjuvant chemotherapy for their ovarian, primary peritoneal, or fallopian tube cancer
Exclusion Criteria:
* Patients with non-epithelial ovarian tumors that do not require adjuvant chemotherapy, borderline epithelial ovarian tumor, or recurrent invasive epithelial ovarian, low grade ovarian cancer, primary peritoneal, or fallopian tube cancer treated with surgery only (such as patients with stage IA or IB); patients with a prior diagnosis of a borderline tumor that was surgically resected and who subsequently develop an unrelated new invasive epithelial ovarian, primary peritoneal, or fallopian tube cancer are eligible, provided that they have not received chemotherapy for any tumor; no stromal cancers or germ cell cancers or low malignant potential; patients found post operatively to have ineligible histology will be removed from the study
* Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded; prior radiation therapy for localized cancer of the breast, head and neck, or skin is permitted provided that it was completed more than 3 years prior to registration, and the patient remains free of recurrent or metastatic disease
* Patients with a synchronous primary endometrial cancer, or a past history of primary endometrial cancer are excluded unless all of the following conditions are met: stage not greater than stage IA; no more than superficial myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated subtypes, including papillary serous, clear cell, or other International Federation of Gynecology and Obstetrics (FIGO) grade 3 lesions
* Patients who have received targeted therapy (including but not limited to vaccines, antibodies, tyrosine kinase inhibitors) or hormonal therapy for management of their primary peritoneal, ovarian, or fallopian tube cancer
* With the exception of non-melanoma skin cancer and other specific malignancies as noted above, patients with other invasive malignancies who had (or have) any evidence of the other cancer present within the last five years or whose previous cancer treatment contraindicates this protocol therapy are excluded
* Metastases to the ovaries from other organs except fallopian tube or primary peritoneal carcinoma
* Use of systemic glucocorticoids such as prednisone or Decadron in the last month
* Inability to accurately answer questions (e.g. dementia, brain metastases) or speak English or Spanish
* Cirrhosis of the liver
* Patients with a Zubrod performance status 3 or 4
* Comorbid conditions: Addison's disease, autoimmune hepatitis, hepatitis B, hepatitis C, acquired immunodeficiency syndrome (AIDS) or human immunodeficiency virus (HIV), lupus erythematosus, mixed connective tissue disease, rheumatoid arthritis
* Any patients already on beta-blockers or contraindicated to receive beta-blockers
* Hypersensitivity to propranolol, or beta-blockers
* Uncompensated congestive heart failure
* Cardiogenic shock
* Severe sinus bradycardia; heart block, second or third degree or sick sinus syndrome (if no artificial pacemaker present)
* Severe hyperactive airway disease (chronic obstructive pulmonary disease, asthma)
* Any patients planning to receive Avastin or any other anti-angiogenic drugs
* Patients with brittle diabetes mellitus (DM); brittle diabetes mellitus is a type of diabetes when a person's blood glucose (sugar) level often swings quickly from high to low and from low to high; also called 'unstable diabetes' or 'labile diabetes'
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT01504126
| 6,837
|
{
"NCT_ID" : "NCT01780220",
"Brief_Title" : "Radiotherapy Plus Hormone Therapy in Biochemically-relapsing Prostate Cancer Patients Following Surgery",
"Official_title" : "Safety and Efficacy of Radiotherapy Combined With a 6-month LH-RH Agonist and Abiraterone Hormone Therapy Treatment in Biochemically-relapsing Prostate Cancer Following Surgery",
"Conditions" : ["Biochemically-relapsing Prostate Adenocarcinoma Following Radical Prostatectomy"],
"Interventions" : ["Drug: Abiraterone"],
"Location_Countries" : ["France"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1", "PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional Model" : "SINGLE_GROUP",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
As there is no prospective data on the combination of abiraterone and salvage radiotherapy, the aim of this study is to further evaluate the safety profile of abiraterone acetate plus prednisone in patients with prostate cancer who are biochemically relapsing after surgery and undergo salvage radiotherapy with 6-months LH-RH agonist.
The investigators hypothesize that the toxicity profile of both treatments should not potentiate each other. This study will also provide preliminary data on the efficacy of this combination.
#Intervention
- DRUG : Abiraterone
- Abiraterone acetate 1000mg/day + prednisone alone for one month before initiating the sequence of radiotherapy
|
#Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed prostate adenocarcinoma
* The patients should have undergone only surgery for localized prostate adenocarcinoma: pT2, pT3 or pT4 with bladder neck involvement
* pN0: negative lymphadenectomy at the time of prostatectomy
* At inclusion the patients should have no clinical signs of progressive disease and should be M0 (bone and pelvic scans).
* >= 18 years with life expectancy >= 10 years
* Performance Status (ECOG) <= 1
* PSA <= 0.1 ng/ml after prostatectomy (dosage performed within 2 months after surgery)
* PSA >= 0.2 ng/ml et <= 2 ng/ml at the time of inclusion
* Elevation of PSA over three consecutive assays performed in the same laboratory, with a minimal interval of two months between assays, (PSA nadir level followed by two other progressive assays)
* At least 6 months between surgery and biochemical relapse
* Serum potassium >= 3.5 mmol/L in the 72 hours before first dose of abiraterone acetate
* Serum creatinine < 1.5 x ULN or a calculated creatinine clearance >= 60 mL/min
* Liver function:
Serum bilirubin < 1.5 x ULN (except for patients with documented Gilbert's disease) AST and ALT < 2.5 x ULN
* Patients must be affiliated to a Social Security System.
* Patient information and written informed consent form signed for both principal and additional research
* Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
Exclusion Criteria:
* pN1: histologically-proven lymph node involvement at initial lymphadenectomy
* Histology other than adenocarcinoma
* Previous hormone therapy including prior therapy with ketoconazole or other CYP17 inhibitor(s) for prostate cancer.
* Patients being treated within the last 14 days prior to inclusion with drugs recognized as being strong inhibitors or inducers of the isoenzyme CYP3A4 (Clarithromycin, Ketoconazole, Itraconazole, Voriconazole, Ritanovir, see appendix 11) or requiring those treatments during the study
* Active or symptomatic viral hepatitis or chronic liver disease
* Surgical or chemical castration
* History of cancer, with the exception of basal cell carcinoma or any other cancer treated in the 5 years before inclusion and in complete remission.
* Previous pelvic radiotherapy
* Uncontrolled hypertension (defined as systolic BP >= 140 mmHg or diastolic BP >= 90 mmHg). Patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive therapy (see appendix 10 for mandatory BP measurement guidelines)
* Severe and moderate hepatic impairment (Child-Pugh class B and C)
* Patients with severe and/or uncontrolled medical disease which could compromise participation in the study, such as, but not limited to:
Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class III or IV heart disease or cardiac ejection fraction measurement of < 50 % at baseline
* Known hypersensitivity to any of the study drugs or excipients.
* Galactosemia, Glucose-galactose malabsorption or lactase deficiency
* Patients with any psychological, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
* Individual deprived of liberty or placed under the authority of a tutor.
* Patients already included in another therapeutic trial with an experimental drug or having been given an experimental drug within a period of 30 days.
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT01780220
| 3,120
|
{
"NCT_ID" : "NCT01452659",
"Brief_Title" : "Efficacy and Safety of TAK-385 in the Treatment of Uterine Fibroids",
"Official_title" : "A Phase II, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of the Efficacy and Safety of TAK-385 10, 20, and 40 mg (p.o.) in the Treatment of Uterine Fibroids",
"Conditions" : ["Uterine Fibroids"],
"Interventions" : ["Drug: TAK-385", "Drug: Placebo"],
"Location_Countries" : ["Japan"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional Model" : "PARALLEL",
"Masking" : "QUADRUPLE"
}
}
|
#Study Description
Brief Summary
The purpose of this study is to determine the efficacy and safety of TAK-385, once daily (QD), for 12 weeks in women with uterine fibroids.
Detailed Description
This study is a Phase II, multicenter, randomized, double-blind, parallel-group, placebo-controlled for evaluation of the efficacy and safety of TAK-385 10, 20, and 40 mg (p.o.) following once daily administration for 12 weeks in women with uterine fibroids.
#Intervention
- DRUG : TAK-385
- TAK-385 10 mg, tablets, orally, once daily for up to 12 weeks.
- DRUG : TAK-385
- TAK-385 20 mg, tablets, orally, once daily for up to 12 weeks.
- DRUG : TAK-385
- TAK-385 40 mg, tablets, orally, once daily for up to 12 weeks.
- DRUG : Placebo
- TAK-385 placebo-matching tablets, orally, once daily for up to 12 weeks.
|
#Eligibility Criteria:
Inclusion Criteria:
* The participant has been diagnosed with uterine fibroids and has never received surgical treatment for the myoma.
* The participant is a premenopausal woman.
* The participant has one or more measurable noncalcified myomas confirmed by transvaginal sonography.
* The participant has experienced regular menstrual cycles
* The participant is diagnosed as menorrhagia
Exclusion Criteria:
* Participants with a screening Hb <8 g/dL
* Participants with a previous or current history of blood disorders
* Participants with a known history of severe hypersensitivity or severe allergy to sanitary goods
* Participants with lower abdominal pain due to irritable bowel syndrome or severe interstitial cystitis
* Participants with a previous or current history of thyroid dysfunction
* Participants with a previous or current history of pelvic inflammatory disease
* Participants with a positive PAP smear test result
* Participants with a history of panhysterectomy or bilateral oophorectomy
* Participants judged by investigator to have marked abnormal uterine bleeding or anovulatory bleeding
* Participants with a previous or current history of a malignant tumor
* Participants who have been treated with any of the following drugs: anticoagulant drug, antiplatelet drug, tranexamic acid, selective estrogen receptor modulator (SERM), activated vitamin D, other vitamin D, calcitonin, ipriflavone, steroid hormone, vitamin K, teriparatide, or denosumab
* Participants who have been treated with any of the following drugs: oral contraceptive and sex hormone preparation, gonadotropin-releasing hormone (GnRH) analogue, dienogest, danazol, or aromatase inhibitor
* Participants who have been treated with a bisphosphonate preparation
* Participants with a previous or current history of severe hypersensitivity or severe allergy to drugs
* Participants with non-diagnosable abnormal genital bleeding
* Participants with a previous or current history of osteoporosis, bone mass loss, or other metabolic bone diseases
* Participants with clinically significant cardiovascular disease or uncontrollable hypertension
* Participants judged by investigator to be inappropriate to participate in this study based on the 12-lead electrocardiogram (ECG) findings
* Participants with active liver disease or jaundice, or with alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin > 1.5 times the upper limit of normal (ULN)
Sex :
FEMALE
Ages :
- Minimum Age : 20 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT01452659
| 29,822
|
{
"NCT_ID" : "NCT00396045",
"Brief_Title" : "Melphalan, Prednisone, and CC-5013 (Revlimid) as Induction Therapy in Multiple Myeloma",
"Official_title" : "A Multicenter, Open Label Study of Oral Melphalan, Prednisone, and CC-5013 (Revlimid) (MPR) as Induction Therapy in Elderly Newly Diagnosed Multiple Myeloma Patients",
"Conditions" : ["Multiple Myeloma"],
"Location_Countries" : ["Italy"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1", "PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NON_RANDOMIZED",
"Interventional Model" : "SINGLE_GROUP",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of the association of Melphalan/Prednisone/Revlimid (MPR) as induction treatment for newly diagnosed myeloma patients over age 65 or those under 65 years who refuse or are not eligible for high dose therapy. This association might further increase the response rate achieved by the standard oral MP regimen.
Detailed Description
In Multiple Myeloma patients, the standard treatment is the oral combination of Melphalan and Prednisone (MP). This approach induces a partial response (PR) rate of approximately 50% and a complete remission (CR) rate of 1-5%, with a median remission duration of 18-20 months and a median overall survival of 3 years.
Recently, the combination of oral MP plus thalidomide increased response rate to 80% and complete remission rate to 20%, marked cytoreduction is the first step toward a sustained remission period.
CC-5013 (Revlimid) is a thalidomide analogue, 50000 times more potent than thalidomide in inhibiting TNF-alfa secretion, a potent growth factor for myeloma cells. Revlimid represents a novel class of anti-cancer drugs, it is active in patients with multiple myeloma who are refractory to conventional and high-dose chemotherapy with a response rate of approximately 30%. The association Revlimid plus dexamethasone further increases the response rate induced by Revlimid by an additional 30%.
This study will evaluate the safety and efficacy of the association of Melphalan/Prednisone/Revlimid (MPR) as induction treatment for newly diagnosed myeloma patients over age 65 or those under 65 years who refuse or are not eligible for high dose therapy. This association might further increase the response rate achieved by the standard oral MP regimen.
In the first part of the study (phase I component), different doses of oral Melphalan (0.18-0.25 mg/Kg) associated with Prednisone (MP) will be combined with escalating doses of Revlimid (from 5 mg/day) and administered together. This phase will define the MTD of the association. In the second part of the study (phase II component), 30 patients will be treated with MPR at dose/s defined from phase I component to verify data of response and toxicity.
#Intervention
- DRUG : Revlimid (CC-5013)
|
#Eligibility Criteria:
Inclusion Criteria:
* Patient is of a legally consenting age as defined by local regulations.
* Age > 65 years or age < 65 years in patients who refuse or are not eligible for high-dose therapy.
* Patient is, in the investigator(s) opinion willing and able to comply with the protocol requirements.
* Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
* Female patient is either post-menopausal for 24 consecutive months or surgically sterilised or agree to continuous abstinence from heterosexual sexual contact or willing to use two acceptable method of birth control at the same time (one highly effective method and one additional effective method)(Highly Effective Methods: Intrauterine device -IUD-; Hormonal -birth control pills, injections, implants-; tubal ligation; partner's vasectomy; Additional Effective Methods: Latex condom; Diaphragm; Cervical Cap) for 4 weeks prior to beginning study drug therapy, during study drug therapy (including dose interruption) and for 4 weeks after discontinuation of Lenalomide therapy - Male patient agrees to use an acceptable method for contraception (i.e., condom or abstinence) during study drug therapy (including dose interruption) and for 4 weeks after discontinuation of Lenalomide therapy.
* Patient was previously diagnosed with symptomatic multiple myeloma based on standard criteria, and has measurable disease, defined as follows: any quantifiable serum monoclonal protein value (generally, but not necessarily, greater than 1 g/dL of IgG M-Protein and greater than 0.5 g/dL of IgA M-Protein) and, where applicable, urine light-chain excretion of >200 mg/24 hours; measurable plasmacytoma as determined by clinical examination or applicable radiographs (i.e. MRI, CT-Scan); bone marrow plasma cells >10%.
* Patient has a Karnofsky performance status >= 60%
* Patient has a life-expectancy > 6 months.
* Patient has the following laboratory values within 14 days before Baseline (day 1 of the Cycle 1):
* Absolute neutrophil count > 1.5 x 109/L without the use of growth factors
* Platelet count > 75 x 109/L without transfusion support within 7 days before the test.
* Calculated or measured creatinine clearance: >= 20 mL/minute
* Total bilirubin < 1.5 x the ULN
* AST (SGOT) and ALT (SGPT) < 2.5 x ULN
* Corrected serum calcium <= 14 mg/dL (3.5 mmol/L
Exclusion Criteria:
* Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
* Pregnant or beast feeding females.
* Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
* Use of any other concomitant standard/experimental anti-myeloma drug or therapy.
* Any prior use of CC-5013 or other anti-myeloma therapy.
* Any of the following laboratory abnormalities:
* Platelet count < 75 x 109/L.
* Absolute neutrophil count <1.5 x 109/L.
* Calculated or measured creatinine clearance <20 mL/minute.
* Corrected serum calcium >14 mg/dL (3.5 mmol/L).
* Aspartate transaminase (AST): >2.5 x the upper limit of normal (ULN).
* Alanine transaminase (AST): > 2.5 x the ULN.
* Total bilirubin: > 1.5 x the ULN.
* Known positive for HIV or active infectious hepatitis, type B or C.
Sex :
ALL
Ages :
- Minimum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT00396045
| 38,674
|
{
"NCT_ID" : "NCT05103293",
"Brief_Title" : "PTC Guiding Neoadjuvant Treatment in Breast Cancer",
"Official_title" : "Neoadjuvant Therapy for Breast Cancer Based on Patient-derived Tumor-like Cell Clusters Advanced Drug Sensitization Regimens: a Phase II Randomized Controlled Clinical Study",
"Conditions" : ["Pathological Conditions, Signs and Symptoms"],
"Interventions" : ["Diagnostic Test: patient-derived tumor-like cell clusters drug sensitivity test"],
"Location_Countries" : ["China"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "SCREENING",
"Allocation" : "RANDOMIZED",
"Interventional Model" : "PARALLEL",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
Patients with breast cancer meet criteria for enrollment are randomized into PTC group or control group. The neoadjuvant therapy regimens are guided by PTC test in the PTC group. The regimens in control group are included of (dd)EC-T for HER2 negative subtype, TCH(P) or EC-TH(P) for HER2 positive subtype. We compared the pCR rate between two groups as the primary endpoint.
Detailed Description
1. Before neoadjuvant therapy, all samples will be obtained by core needle biopsy for PTC drug sensitivity test.
2. After obtaining drug sensitivity results and confirming ER/PR and HER2 expression state, all recruited patients will be randomized into the PTC group or the routine treatment group, according to the method of random number table.
3. Beijing Cornerstone Life Science and Technology Co., Ltd. is responsible for gene sequencing and PTC drug sensitivity test for biological samples. All samples for the study are clinical residuals and will be used in the study, store or destruction is unapplicable.
4. Neoadjuvant therapy regimen in the PTC group is guided by PTC drug sensitivity results, and regimen in the routine treatment group is based on clinical guideline, such as (dd)EC-T for HER2 negative breast cancer, and TCH(P) or EC-TH(P) for HER2 positive breast cancer. All neoadjuvant therapy will be completed before operation if without PD.
5. According to postoperative pathological remission, pCR patients in two groups continued to complete adjuvant targeted therapy based on original treatment. For non-pCR patients in the PTC group, PTC drug sensitivity test will be done again to guide adjuvant therapy, for non-pCR patients in the routine treatment group, Capecitabine for HER2 negative breast cancer, and T-DM1 or H(P) will be selected.
6. All patients will be received radiotherapy or endocrine therapy if necessary.
#Intervention
- DIAGNOSTIC_TEST : patient-derived tumor-like cell clusters drug sensitivity test
- Intervention Description：Neoadjuvant therapy regimen of patients in the PTC group is guided by PTC drug sensitivity results. After operation, adjuvant targeted therapy for pCR patients is based on original treatment, adjuvant targeted therapy for non-pCR patients is based on a secondary PTC drug sensitivity results.
- Other Names :
- PTC
|
#Eligibility Criteria:
Inclusion Criteria:
* Female between 18 <= age <= 70 old.
* Patients diagnosed with invasive breast cancer by pathology.
* Clinical stage considered as T2 <= age <= 4N0 <= age <= 2M0 .
* HER2 overexpression by IHC or FISH positive.
* Patients plan to accept neoadjuvant therapy or plan to accept adjuvant therapy after neoadjuvant therapy and surgery.
Exclusion Criteria:
* Patients have already accepted any other anti-tumor treatment not included in our project.
* Patients with metastasis are not considered surgery therapy.
* Patients cannot accept chemotherapy or anti-HER2 targeted therapy, because of severe cardiovascular diseases or other reasons
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT05103293
| 34,490
|
{
"NCT_ID" : "NCT01365182",
"Brief_Title" : "Improving Urinary Continence and Quality of Life in Prostate Cancer Patients",
"Official_title" : "Improving Urinary Continence and Quality of Life in Prostate Cancer Patients",
"Conditions" : ["Urinary Incontinence"],
"Interventions" : ["Behavioral: BF+PHONE", "Behavioral: BF+SUPPORT"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional Model" : "PARALLEL",
"Masking" : "SINGLE"
}
}
|
#Study Description
Brief Summary
This intervention program combines biofeedback PFME with a telephone or support group intervention to treat persistent urinary incontinence (UI). The study's primary aims are to improve continence, quality of life, and mood through enhancing adherence to PFME and self-management of incontinence symptoms. The secondary aims are to examine the physiological effects and cost effectiveness of the proposed interventions.
Detailed Description
This is a randomized, controlled longitudinal study. Patients with early-stage prostate cancer and UI for more than six months were randomly assigned to one of three study arms: (1) biofeedback PFME plus a support group (BF+SUPPORT); (2) biofeedback PFME plus telephone (BF+PHONE); and (3) usual care (UC). The BF+SUPPORT and BF+PHONE participants learned PFME through computerized biofeedback. Thereafter, the BF+SUPPORT participants attended six group meetings and the BF+PHONE participants had six phone contacts every other week for three months. The UC participants did not receive biofeedback PFME or telephone/group intervention but continued receiving usual medical care. All subjects were assessed blind at baseline, 3 months (post intervention) and 6 months (follow-up). In addition, 49 moderately to severely incontinent patients were recruited from the three study groups to undergo urodynamic testing at baseline and 3 months for the evaluation of physiological changes. Data of the costs for the interventions and the participants' medical care were collected for a cost-effectiveness analysis.
#Intervention
- BEHAVIORAL : BF+SUPPORT
- A session of biofeedback-assisted pelvic floor muscle exercises (PFME) plus 6 group sessions of the Problem-Solving Therapy (teaching self-management skills).
- BEHAVIORAL : BF+PHONE
- A session of biofeedback-assisted pelvic floor muscle exercises (PFME) plus 6 telephone sessions of the Problem-Solving Therapy (teaching self-management skills).
|
#Eligibility Criteria:
Inclusion Criteria:
* Have been diagnosed with early stage (I-III) prostate cancer.
* Have completed cancer treatments six months prior.
* Presence of incontinence symptoms
Exclusion Criteria:
* Receiving hormonal treatment.
* Urinary tract infection or urinary retention.
* Cognitive impairment.
* Having an implant
Sex :
MALE
Ages :
- Minimum Age : 21 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT01365182
| 968
|
{
"NCT_ID" : "NCT04148066",
"Brief_Title" : "ctDNA Guided Treatment of Early Resistance to Targeted Treatment",
"Official_title" : "Track and Treat in NSCLC (TATIN) - ctDNA Guided Treatment of Early Resistance to Targeted Treatment in Patients With EGFR Positive NSCLC",
"Conditions" : ["Carcinoma, Non-Small-Cell Lung"],
"Interventions" : ["Diagnostic Test: ctDNA blood sample"],
"Location_Countries" : ["Netherlands"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional Model" : "SINGLE_GROUP",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
The current strategy is to test for treatment resistance at the time of radiological progression and design subsequent treatment based on the mechanism of resistance. However, upon disease progression patients tend to deteriorate quickly and 30% - 40% of patients will not be in the clinical condition to receive next line treatment. Therefore, there is a potential for early resistance identification and directing treatment against it in order to improve patient outcome.
Detailed Description
Next Generation Sequence (NGS) technology rapidly evolves and it is now feasible to use circulating tumor DNA (ctDNA) as a BioSource for comprehensive analysis of the molecular make up of tumors. ctDNA based techniques are able to detect the emergence of drug resistance mechanisms with high sensitivity and prior to radiological progression (12-14). This technique might identify drug resistant clones before subclonal resistance (resistance of the new clone to targeted treatment) develops and allow to eliminate the new clone with short-term additional treatment, while continuing treatment of the main oncogenic driver (EGFR exon 19 del / exon 21 L858R) with the EGFR TKI. Continuous ctDNA based monitoring will reveal the success of the additional treatment and in case the follow-up ctDNA sample shows elimination of the EGFR TKI resistant clone, the add-on treatment will be discontinued. Continuous ctDNA based monitoring might identify a new resistant clone at a later point in time and temporary treatment of this clone can be initiated. The EGFR TKI will remain the backbone of therapy and will not be discontinued (see treatment strategy 1 in Figure 3).
This continuous track and treat strategy could potentially lead to a better outcome. In this study the investigators will track all known EGFR TKI resistance mechanisms over time and select one (MET amplification) for the track and treat strategy.
Treatment strategy 1: Track and treat strategy. ctDNA based resistance monitoring. As soon as a resistant clone is detected with ctDNA, treatment will be added to the EGFR TKI. ctDNA will be continuously screened for resistant clones. Upon disappearance of the resistant clone, add-on treatment will be discontinued, while the EGFR TKI will be continued at any time. Multiple resistance mechanisms can be treated serially.
Treatment strategy 2: routine care. Treatment with an EGFR TKI will be continued until radiological progression.
#Intervention
- DIAGNOSTIC_TEST : ctDNA blood sample
- every six weeks during treatment and upon radiological progression blood will be drawn to analyse ctDNA with Avenio ctDNA (Expanded panel) to detect all known EGFR TKI resistance mechanisms.
|
#Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed metastatic NSCLC, characterized by a sensitizing exon 19 deletion or exon 21 L858R EGFR mutation.
* WHO performance status 0 <= age <= 2.
* Eligible for osimertinib treatment according to the label and according to the treating physician.
* Patients must be >=18 years.
Exclusion Criteria:
* Patients with symptomatic central nervous system metastases who are neurologically unstable. Unstable brain metastases except for those who have completed definitive therapy and have had a stable neurological status for 2 weeks after completion of definitive therapy. Patients may be on corticosteroids to control brain metastases if they have been on a stable dose for 2 weeks prior to the start of study treatment and are clinically asymptomatic.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT04148066
| 2,156
|
{
"NCT_ID" : "NCT04009122",
"Brief_Title" : "Evaluation of the Quality of Life of Patients With Metastatic Non-small Cell Lung Cancer With Supplementary Therapy With IGEN-0206",
"Official_title" : "Evaluation of the Quality of Life of Patients With Metastatic Non-small Cell Lung Cancer With Supplementary Therapy With IGEN-0206",
"Conditions" : ["Quality of Life of Patients", "Non-small Cell Lung Cancer Metastatic"],
"Interventions" : ["Dietary Supplement: IGEN0206", "Other: Placebo"],
"Location_Countries" : ["Spain"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional Model" : "PARALLEL",
"Masking" : "QUADRUPLE"
}
}
|
#Study Description
Brief Summary
A national, multicenter, blind, randomized study of three groups, designed to evaluate the impact on the quality of life of IGEN-0206 (IGEN-0206 is a nutritional product, a food) with nutritional support + standard treatment versus nutritional support + standard treatment versus standard treatment in patients with non-lung cancer metastatic microcytic.
The standard treatment can include any line of active treatment (chemotherapy, immunotherapy, biological therapies or targeted therapies), radiotherapy or nonspecific symptomatic treatment.
It will include 280 patients older than 18 years, who have a life expectancy of less than 9 months, who will receive or not active treatment.
After signing the informed consent and confirmation that the subject meets the eligibility criteria, those will be randomized (2: 2: 1 ratio) to receive treatment:
* Group A (112 patients): patients will receive their standard treatment + nutritional support + IGEN-0206
* Group B (112 patients): patients will receive their standard treatment + nutritional support + placebo.
* Group C (56 patients): patients will receive standard treatment. The allocation will be random 2: 2: 1 and will be stratified according to ECOG 1 versus 2-3, type of oncological treatment (chemotherapy, immunotherapy and / or radiotherapy versus targeted therapies versus symptomatic treatment) and type of cancer (squamous versus not flaky).
The present study seeks to demonstrate that IGEN-0206 improves the quality of life and the nutritional status of patients with non-small cell lung cancer. If an improvement in the quality of life is achieved, this could impact on a reduction in the number of treatment delays / omissions, which could secondarily impact on a response and survival benefit (by improving the relative intensity of the active oncological treatment).
#Intervention
- DIETARY_SUPPLEMENT : IGEN0206
- Group A
- OTHER : Placebo
- Group B
|
#Eligibility Criteria:
Inclusion Criteria:
* Patient who has given informed consent in writing, stating that he / she understands the purpose of the study and the procedures it entails, and that he / she agrees to participate.
* Patient with metastatic non-small cell lung carcinoma confirmed by Pathology.
* Expected life expectancy exceeding 12 weeks.
* Age >=18 years.
* Functional status of the ECOG 1 <= age <= 3.
* Patients who can consume at least 500 ml per day of the nutritional supplement, added to their diet.
* Patients who do not meet criteria for renal failure: the glomerular filtrate, calculated by local formula, must be >=60 ml / min / 1.73m2.
* Patients who are willing to communicate the use of nutritional supplements, including oral supplements, vitamins and mineral supplements and / or any food supplement
* Patients who are willing to comply with the protocol procedures after having been thoroughly informed about the treatment, the procedures, reviewing the study methodology and signing the informed consent.
* They speak fluent Spanish in order to be able to complete the questionnaires of the study.
* Potentially fertile women must be negative in a serum pregnancy test performed within 7 days prior to entry into the study. Potentially fertile patients participating in this study should use effective contraceptive methods (eg, abstinence, intrauterine device, oral or injectable contraceptives, double-barrier method, or surgical sterilization) to prevent pregnancy, which they will begin to use as of signature of the informed consent document and whose use will continue until at least 13 weeks after the last dose of the study medication has been administered.
Exclusion Criteria:
* Women who are pregnant and / or breast-feeding.
* Persistence of the toxicity of a previous treatment (grade> 1 of the NCI-CTCAE v. 4.03); However, alopecia and sensory neuropathy of grade <= 2 are acceptable, as well as other side effects that do not endanger patient safety in the opinion of the researcher.
* Evidence of severe or uncontrolled systemic disease or concomitant process that, in the opinion of the investigator, makes the participation of the subject in the study inadvisable or compromises compliance with the protocol.
* Dementia or mental state significantly altered that could interfere in the understanding and granting of informed consent.
* Parkinson's disease
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT04009122
| 10,683
|
{
"NCT_ID" : "NCT01938313",
"Brief_Title" : "Early Recovery After Surgery (ERAS) Versus Conventional Protocol After Laparoscopic Gastrectomy",
"Official_title" : "Comparison of ERAS (Early Recovery After Surgery) Protocol With Conventional Protocol After Laparoscopic Gastrectomy: A Prospective Randomized Controlled Trial (Phase II Study))",
"Conditions" : ["Gastric Cancer"],
"Interventions" : ["Procedure: Conventional perioperative cares", "Procedure: ERAS perioperative cares"],
"Location_Countries" : ["Korea, Republic of"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional Model" : "PARALLEL",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
Enhanced Recovery After Surgery (ERAS) programs have been introduced with purposes of reducing the surgical stress response and obtaining optimal recovery after surgery.
Detailed Description
There is strong evidence of the usefulness of the ERAS programs in patients undergoing colorectal surgery in terms of significantly reduced postoperative complications and shorter length of hospital stay, compared to the patients of conventional treatment.
However, few studies exist about the implication of ERAS programs in the laparoscopic gastrectomy.
The aim of this study was to compare the recovery rate, morbidity, and quality of life in the patients undergoing laparoscopic gastrectomy for gastric cancer, receiving either ERAS protocol or conventional postoperative cares.
#Intervention
- PROCEDURE : ERAS perioperative cares
- 1. Patient's preoperative counseling \& education before surgery
2. No Bowel preparation
3. Oral Carbohydrate Solution (OCS) loading until 2hours before surgery
4. Fluid restriction \& Management by pulse contour analysis or transesophageal doppler
5. Early mobilization
6. Early oral feeding (postoperative 1 day - sips of water, 2 days - semifluid diet (SFD), 3 days - soft blended diet (SBD))
7. Epidural patient controlled analgesics (no opioids analgesics)
8. Postoperative Nausea Active Control
9. Thromboembolism prophylaxis by low molecular weighted heparin (LMWH)
10. Perioperative High content Oxygen therapy
11. No drain insertion
12. No Levin tube
13. Patients will be discharged at POD#4 if there's no problem.
- PROCEDURE : Conventional perioperative cares
- 1. No Patient's preoperative counseling \& education before surgery
2. Bowel preparation
3. No Oral Carbohydrate Solution (OCS) loading until 2hours before surgery
4. Conventional Fluid Management by clinical signs (Urine output, heart rate etc.)
5. Conventional Mobilization
6. Conventional oral feeding (POD#2 SOW, #3 SFD, #4 SBD)
7. IV PCA
8. Postoperative Nausea Control if needed
9. No Thromboembolism prophylaxis
10. No or Low Content Oxygen therapy
11. Routine drain insertion
12. Levin tube insertion if needed
|
#Eligibility Criteria:
Inclusion Criteria:
* Elective surgery
* American Society of Anesthesiologists (ASA) scores < 3
* 20 < Age < 80
* Gastric cancer, adenocarcinoma, possible to perform laparoscopic distal gastrectomy
* Informed consent
* No other treatment (Radiation, Chemotherapy or Immunotherapy) on this gastric cancer or other type of cancer.
* No systemic inflammatory disease
Exclusion Criteria:
* Emergency operation
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT01938313
| 20,506
|
{
"NCT_ID" : "NCT05800483",
"Brief_Title" : "Improving Decision-Making for Low Health Literate Prostate CA Patients",
"Official_title" : "Improving Decision-Making for Low Health Literate Prostate CA Patients",
"Conditions" : ["Prostate Cancer"],
"Interventions" : ["Behavioral: Healium"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "HEALTH_SERVICES_RESEARCH",
"Allocation" : "RANDOMIZED",
"Interventional Model" : "PARALLEL",
"Masking" : "DOUBLE"
}
}
|
#Study Description
Brief Summary
This study used a randomized controlled trial to evaluate whether Healium (designed to target preference elicitation) is as efficacious as Healing Choices (a comprehensive education and decision tool) in improving outcomes for decision-making and emotional quality of life.
Detailed Description
Background: Elicitation of patients' preferences is an integral part of shared decision making, the recommended approach for prostate cancer decision making. However, existing decision aids for this population do not specifically focus on patients' preferences. Healium is a brief interactive web-based decision aid that aims to elicit patient's treatment preferences and is designed for a low health literate population. This study used a randomized controlled trial to evaluate whether Healium (designed to target preference elicitation) is as efficacious as Healing Choices (a comprehensive education and decision tool) in improving outcomes for decision-making and emotional quality of life.
Method: Patients diagnosed with localized prostate cancer who had not yet made a treatment decision were randomly assigned to the brief Healium intervention or Healing Choices, an extensive decision aid previously developed by our group that serves as a virtual information center on prostate cancer diagnosis and treatment. Assessments were completed at baseline, 6-weeks and 3-months post-baseline, and included decisional outcomes (decisional conflict, satisfaction with decision, preparation for decision-making), and emotional quality of life (anxiety/tension and depression), along with demographics, comorbidities, and health literacy.
#Intervention
- BEHAVIORAL : Healium
- web-based platform to elicit patients' preferences about prostate cancer treatment and designed for low health literature populations
|
#Eligibility Criteria:
Inclusion Criteria:
* a diagnosis of localized prostate cancer and eligible for all treatment options (ie., surgery, radiation, active surveillance);
* had not yet made a treatment decision or begun treatment; and
* have basic proficiency (grade school level) in reading English.
Exclusion Criteria:
* none
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT05800483
| 35,155
|
{
"NCT_ID" : "NCT01197612",
"Brief_Title" : "Nasal Packing as a Drug Delivery System Postoperatively in Chronic Sinusitis With Polyposis",
"Official_title" : "Nasal Packing as a Drug Delivery System Postoperatively in Chronic Sinusitis With Polyposis",
"Conditions" : ["Chronic Sinusitis", "Polyposis"],
"Interventions" : ["Drug: pulmicort"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE3"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional Model" : "SINGLE_GROUP",
"Masking" : "TRIPLE"
}
}
|
#Study Description
Brief Summary
That high-dose steroid applied to the nasal cavity immediately post-operatively will improve olfaction and healing following endoscopic sinus surgery.
#Intervention
- DRUG : pulmicort
- applied to nasal packing after surgery
- Other Names :
- budesonide
|
#Eligibility Criteria:
Inclusion Criteria:
* hyposmia and nasal obstruction for >12 weeks
* bilateral nasal polyposis
* candidate for surgery
Exclusion Criteria:
* immunocompromised
* non-English speaking
* prisoner
* pregnant/lactating
* will not attend follow up appointments
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 99 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT01197612
| 14,547
|
{
"NCT_ID" : "NCT01352728",
"Brief_Title" : "Hepatocellular Carcinoma (HCC) Transarterial Chemoembolisation (TACE) +Axitinib",
"Official_title" : "A Phase II Study of Transarterial Chemoembolisation and Axitinib for the Treatment of Unresectable Hepatocellular Carcinoma",
"Conditions" : ["Hepatocellular Carcinoma"],
"Interventions" : ["Drug: Axitinib"],
"Location_Countries" : ["Hong Kong"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional Model" : "SINGLE_GROUP",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
The survival of subjects with unresectable hepatocellular carcinoma (HCC) receiving transarterial chemoembolization is improved with addition of axitinib.
#Intervention
- DRUG : Axitinib
- 5 mg daily for 6 cycle with TACE+Axitinib, Axitinib continued until PD.
|
#Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed HCC (or fulfilling AASLD criteria for HCC diagnosis in HBsAg positive subjects with cirrhosis in case biopsy is not feasible)
* Disease must not be amenable to potentially curative surgery
* Without prior systemic nor transarterial treatment
* Prior surgery or local therapy is allowed but the target lesion must have not been previously treated
* Child-Pugh stage A liver function
* ECOG performance 0 <= age <= 2
* Life expectancy longer than 12 weeks
* At least one measurable treatment lesion according to modified RECIST criteria
* Adequate haematological, hepatic and renal function
Exclusion Criteria:
* Contra-indications to TACE treatment:
* Main portal vein thrombosis or occlusion
* Evidence of biliary obstruction
* Presence of extra-hepatic disease
* Diffuse-type HCC
* Major surgery <4 weeks or radiation therapy <2 weeks of starting the study treatment.
* Any form of prior transarterial therapy or systemic therapy for HCC.
* Current use or anticipated need for treatment with drugs that are known potent CYP3A4 inhibitors or CYP3A4 or CYP1A2 inducers.
* Requirement of anticoagulant therapy with oral vitamin K antagonists. Low dose anticoagulants for maintenance of patency of central venous access devise or prevention of deep venous thrombosis is allowed. Therapeutic use of low molecular weight heparin is allowed.
* Any haemorrhage or bleeding event of CTCAE Grade 3 or more within 4 week
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT01352728
| 35,859
|
{
"NCT_ID" : "NCT03167619",
"Brief_Title" : "Phase II Multicenter Study of Durvalumab and Olaparib in Platinum tReated Advanced Triple Negative Breast Cancer (DORA)",
"Official_title" : "Phase II Multicenter Study of Durvalumab and Olaparib in Platinum tReated Advanced Triple Negative Breast Cancer",
"Conditions" : ["Triple Negative Breast Cancer"],
"Interventions" : ["Drug: Olaparib Oral Product", "Drug: Olaparib Oral Product in combination with Durvalumab"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional Model" : "PARALLEL",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
This is a randomized, international, multicenter, Phase II study designed to explore the efficacy of olaparib or olaparib in combination with durvalumab in platinum-treated mTNBC. The primary objectives are to explore olaparib or olaparib in combination with durvalumab as maintenance therapy following clinical benefit with platinum-based therapy in subjects with mTNBC.
Detailed Description
Subjects suitable for enrollment into this trial are adult subjects with histologically documented triple negative adenocarcinoma of the breast that is inoperable, locally advanced, or metastatic, and is not amenable to resection with curative intent, and who have received at least 4 cycles of platinum-based chemotherapy in the 1st or 2nd line setting AND derived clinical benefit (CR / PR / SD) per RECIST 1.1 with platinum-based therapy as determined by the treating physician.
Eligible subjects will be randomized to either olaparib or olaparib in combination with durvalumab. Study treatment will continue until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination. Upon treatment discontinuation, subjects will be followed every 2 months for survival.
Although randomization will be used to allocate subjects to either the olaparib or olaparib in combination with durvalumab arm, no comparisons between treatment regimens are planned. The purpose of randomization was to reduce bias due to subject selection into either treatment arm.
#Intervention
- DRUG : Olaparib Oral Product
- olaparib 300mg twice daily
- DRUG : Olaparib Oral Product in combination with Durvalumab
- olaparib 300mg twice daily plus intravenous durvalumab every 28 days
|
#Eligibility Criteria:
Inclusion Criteria:
* Age >= 21 years
* ECOG performance status 0 <= age <= 2
* Inoperable locally advanced or metastatic breast cancer not amenable to resection with curative intent and histologically confirmed to be estrogen receptor (ER) negative, progesterone receptor (PR) negative, and HER2 negative:
* ER negative status is defined as < 1% tumor cells positive for ER by immunohistochemistry (IHC), irrespective of staining intensity
* PR negative status is defined as < 1% tumor cells positive for PR by IHC, irrespective of staining intensity
NOTE: Enrollment is permitted for ER/PR low-expression subjects (defined as <= 10%) who are expected to benefit from this trial at the investigator's discretion.
* HER2 negative status is determined by:
* IHC 1+, as defined by incomplete membrane staining that is faint/barely perceptible and within > 10% of invasive tumor cells, or
* IHC 0, as defined by no staining observed or membrane staining that is incomplete and is faint/barely perceptible and within <= 10% of the invasive tumor cells, or
* FISH negative based on:
* Single-probe average HER2 copy number < 4.0 signals / cell, or
* Dual-probe HER2/CEP17 ratio < 2.0 with an average HER2 copy number < 4.0 signals / cell
* Minimum six 1-weekly doses or three 3-weekly doses of platinum chemotherapy (monotherapy or combination therapy at investigator's discretion) with stable disease (SD), partial response (PR) or complete response (CR) to the platinum therapy as assessed by investigator.
* Has received no more than 2 prior chemotherapy regimens for metastatic breast cancer including current platinum based chemotherapy.
* Able to provide a representative formalin-fixed, paraffin embedded tumour specimen archival or fresh tissue for correlative studies and biomarker analysis.
* Hemoglobin >= 9.0 g/dL and no blood transfusions in the 28 days prior to study entry. Absolute neutrophil count >=1,500/mm3. Platelet count >=100 x 10^9/L.
* Total bilirubin <1.5 x the upper limit of normal (ULN) with the following exception: subjects with known Gilbert's disease who have serum bilirubin <3 x ULN may be enrolled.
* Aspartate transaminase (AST) and alanine transaminase (ALT) <2.5 x ULN with the following exceptions: subjects with documented liver or bone metastases may have AST and ALT <5 x ULN.
* Alkaline phosphatase (ALP) <2 x ULN (<5 x ULN in subjects with known liver involvement and <7 ULN in subjects with known bone involvement).
* Serum creatinine <1.5 x ULN or creatinine clearance >51 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance.
* For subjects of childbearing potential, agreement (by both subject and partner) to use two effective forms of contraception, including surgical sterilization, reliable barrier method, birth control pills, contraceptive hormone implants, or true abstinence and to continue its use for the duration of the study and for 3 months after last dose of study treatment.
* Subjects of childbearing potential should have a negative urine or serum pregnancy test during their screening visit. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
* Subjects willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examination.
* For inclusion in genetic research, subjects must provide informed consent for genetic research collection of specimens to be stored at repository for future research.
Exclusion Criteria:
* Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigation device within 4 weeks of first dose of treatment. Subjects who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks since last dose of the previous investigational agent or device.
* Concurrent enrollment in another clinical study, unless it is an observational (non interventional) clinical study or the follow-up period of an interventional study.
* Active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, or similar treatment) is not considered a form of systemic treatment.
* Is taking chronic systemic steroids in doses > 10mg of prednisolone or equivalent within 7 days prior to the first dose of trial treatment.
* Previous treatment with PARP inhibitors including olaparib.
* Patients that have required discontinuation of treatment due to treatment-related toxicities from prior therapy with PD-1, PDL-1 or CTLA-4 inhibitors or previous history of immune-related grade 3 or 4 adverse event.
* Known active central nervous system metastasis and / or carcinomatous meningitis. Subjects with previously treated brain metastases may participate, provided they have:
1. Stable brain metastases [without evidence of progression by imaging (confirmed by computerized tomography {CT} scan if CT used at prior imaging) for at least four weeks prior to the first dose of trial treatment**,
2. No evidence of new or enlarging brain metastases; any neurologic symptoms should have returned to baseline,
3. Not used steroids for brain metastases in the 7 days prior to trial initiation. Taking chronic systemic steroids in doses <= 10mg of prednisolone is allowed.
* This exception does not include carcinomatous meningitis, as subjects with carcinomatous meningitis are excluded regardless of clinical stability.
* History and/or confirmed pneumonitis, or extensive bilateral lung disease on high resolution/spiral CT scan.
* Patients with suspected or confirmed myelodysplastic syndrome/acute myeloid leukemia.
* History of another primary malignancy except for:
1. Malignancy treated with curative intent and with no known active disease >=5 years before the first dose of study drug and of low potential risk for recurrence.
2. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
3. Adequately treated carcinoma in situ without evidence of disease eg, cervical cancer in situ.
* Major surgery within 2 weeks of starting the study, and subjects must have recovered from any effects of any major surgery.
* Receipt of radiation therapy within 4 weeks prior to starting study drug(s). Limited field of radiation for palliation within 2 weeks of the first dose of study treatment is allowed provided:
1. The lung is not in the radiation field
2. Irradiated lesion(s) cannot be used as target lesions
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease, active bleeding diatheses including any subjects known to have evidence of acute or chronic hepatitis B, hepatitis C or human immunodeficiency virus (HIV), or psychiatric illness / social situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent.
* Subjects unable to swallow orally administered medication, and subjects with gastrointestinal disorders likely to interfere with absorption of the study medication.
* Subjects requiring treatment with potent inhibitors or inducers of CYP3A4.
* Pregnant or breast-feeding women. If breastfeeding can be stopped prior to study enrollment until 1 month after the last study dose, then the patient could be allowed to enter the study.
* Immunodeficient subjects, eg, subjects who are known to be serologically positive for human immunodeficiency virus (HIV).
* Received a live vaccine within 30 days of planned start of study therapy.
* Subjects with a known hypersensitivity to olaparib or durvalumab, or any of the excipients of the product.
* Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis)
* History of allogeneic organ transplant
* Active bleeding diatheses
* Patients with known active hepatic disease (ie, Hepatitis B or C)
* Known history of previous clinical diagnosis of tuberculosis.
Sex :
FEMALE
Ages :
- Minimum Age : 21 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT03167619
| 18,433
|
{
"NCT_ID" : "NCT02427399",
"Brief_Title" : "Conducting Outreach to Improve Cervical Cancer Screening Rates Among Underscreened Patients",
"Official_title" : "Conducting Outreach to Improve Cervical Cancer Screening Rates Among Underscreened Patients at an Urban Community Health Center",
"Conditions" : ["Uterine Cervical Neoplasms"],
"Interventions" : ["Other: Phone", "Other: Email", "Other: Letter and informational sheet", "Other: Multimodal"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "SCREENING",
"Allocation" : "RANDOMIZED",
"Interventional Model" : "FACTORIAL",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
The purpose of this project is to determine whether outreach to HIV-negative patients who are overdue for a Pap smear at a New England urban community health center can increase cervical cancer screening rates. It additionally seeks to determine which form of outreach - via letter, email, phone, or a mixture of those modalities- is most effective among these patients.
Detailed Description
To the investigators' knowledge, this study will be the first to assess the efficacy of email in cervical cancer screening outreach in a randomized controlled trial. It will also be one of the few randomized controlled trials to directly compare different outreach media directly, as opposed to different variations within a single medium (e.g. two different types of letters). Lastly, given the unique patient demographic makeup at Fenway, including a significant number of lesbian, bisexual and transgender patients, secondary subanalyses have the potential to significantly add to the investigators' knowledge of what media work best in conducting cervical cancer screening outreach with sexual and gender minorities, who are disproportionately underscreened compared to heterosexual cis-gendered women.
#Intervention
- OTHER : Letter and informational sheet
- The patients in this group will be mailed a letter at time 0. The letter will inform the patient that she is overdue for a Pap and will also contain an informational sheet about cervical cancer and Pap tests.
- OTHER : Email
- The same text shared in the letter will be sent as an email to the patients in this intervention group, again at time 0, 1, and 2 months, as necessary for nonresponders.
- OTHER : Phone
- The patient will be telephoned and informed that they are due for a Pap, and given the opportunity to schedule an appointment over the phone immediately. Patients will be contacted at time 0, 1, and 2 months as necessary for nonresponders.
- OTHER : Multimodal
- The patient will be sent a letter/informational sheet at time 0. If she does not respond within one month, she will be sent an email. If she does not respond by 2 months after the start of the intervention period, she will be called.
|
#Eligibility Criteria:
Inclusion Criteria:
* Female or female-to-male transgender patients with a cervix
* HIV-negative
* Medical appointment at Fenway Community Health during calendar year 2012 who have not had a Pap smear in the past 3 years (since January 2010)
Exclusion Criteria:
* HIV-positive (due to different Pap testing guidelines)
* Male-to-female transgender patients
* Patients with a history of a hysterectomy, unless specified as partial or supracervical
* Patients aged 30 <= age <= 64 who had a negative Pap test in the past 5 years with simultaneous negative Human papillomavirus infection (HPV) co-testing
Sex :
FEMALE
Ages :
- Minimum Age : 21 Years
- Maximum Age : 64 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02427399
| 28,063
|
{
"NCT_ID" : "NCT03395080",
"Brief_Title" : "A Study of DKN-01 as a Monotherapy or in Combination With Paclitaxel in Patients With Recurrent Epithelial Endometrial or Epithelial Ovarian Cancer or Carcinosarcoma",
"Official_title" : "A Phase 2 Study Evaluating the Efficacy and Safety of DKN-01 as a Monotherapy or in Combination With Paclitaxel in Patients With Recurrent Epithelial Endometrial, Epithelial Ovarian Cancer, or Carcinosarcoma",
"Conditions" : ["Endometrial Cancer", "Uterine Cancer", "Ovarian Cancer", "Carcinosarcoma"],
"Interventions" : ["Drug: 300mg DKN-01", "Drug: 600mg DKN-01", "Drug: Paclitaxel"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NON_RANDOMIZED",
"Interventional Model" : "PARALLEL",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
A Phase 2 Study Evaluating the Efficacy and Safety of DKN-01 as a Monotherapy or in Combination with Paclitaxel in Patients With Recurrent Epithelial Endometrial Cancer, Epithelial Ovarian Cancer, or Carcinosarcoma
Detailed Description
This study employs a 'basket' design to concurrently investigate DKN-01 as monotherapy and in combination with paclitaxel in patients with recurrent epithelial endometrial cancer (EEC), epithelial ovarian cancer (EOC), or carcinosarcoma (malignant mixed Mullerian tumor \[MMMT\]. Thus, 6 distinct patient groups are being independently investigated:
1. 300mg DKN-01 monotherapy in recurrent EEC (Group 1)
2. 300mg DKN-01+paclitaxel in recurrent EEC (Group 2)
3. 300mg DKN-01 monotherapy in recurrent EOC (Group 3)
4. 300mg DKN-01+paclitaxel in recurrent EOC (Group 4)
5. 600mg DKN-01 monotherapy in recurrent carcinosarcoma (MMMT) (Group 5)
6. 600mg DKN-01+paclitaxel in recurrent carcinosarcoma (MMMT) (Group 6)
#Intervention
- DRUG : Paclitaxel
- Administered by IV infusion
- Other Names :
- Taxol
- DRUG : 300mg DKN-01
- Administered by IV infusion
- DRUG : 600mg DKN-01
- Administered by IV infusion
|
#Eligibility Criteria:
Inclusion Criteria:
* Diagnosis:
1. Epithelial Endometrial Cancer: histologically confirmed diagnosis (by either primary surgical specimen or biopsy for recurrence) of recurrent previously treated EEC.
2. Epithelial Ovarian Cancer: histologically confirmed diagnosis (by either primary surgical specimen or biopsy for recurrence) of recurrent platinum-resistant/refractory EOC, primary peritoneal, or fallopian tube cancer (i.e., disease recurrence within 6 months of completion of or progression during platinum-based chemotherapy).
3. Carcinosarcoma/Malignant Mixed Mullerian Tumors: histologically confirmed diagnosis (by either primary surgical specimen or biopsy for recurrence) of recurrent uterine or ovarian carcinosarcoma (MMMT). Patients must have had only 1 prior chemotherapeutic regimen for management of carcinosarcoma that may have been included chemotherapy (including in adjuvant setting), chemotherapy and radiotherapy, and/or consolidation/maintenance therapy.
* Refractory or intolerant to at least one prior standard therapy(ies) for metastatic or locally advanced disease (see Inclusion Criterion #1c for Groups 5 <= age <= 6).
1. If prior therapy consisted of palliative chemoradiation therapy, it will be considered one line of therapy.
2. Prior treatment with paclitaxel as part of definitive therapy regimen is acceptable, provided the patient is not intolerant of paclitaxel.
3. Patients who are not eligible to receive paclitaxel will be allowed to receive single agent DKN-01.
* Tumor tissue for mandatory pre-treatment and on-treatment biopsies.
* One or more tumors measurable on radiographic imaging as defined by RECIST 1.1.
* Ambulatory and >=18 years.
* ECOG performance status (PS) of 0 or 1
a. ECOG PS of 2 may be eligible upon the review and approval of the Medical Monitor.
* Estimated life expectancy of at least 3 months, in the judgment of the Investigator.
* Disease-free of active second/secondary or prior malignancies for >=2 years with the exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix or breast.
* Acceptable liver, renal, hematologic and coagulation function
* Females of child bearing potential and male partners of female patients must agree to use adequate contraception during the study and for 6 months after their last dose of study drug.
* Reliable and willing to make themselves available for the duration of the study and are willing to follow study-specific procedures.
* Provided written informed consent prior to any study-specific procedures.
Exclusion Criteria:
* Patients with the following pure histologies of endometrial or ovarian cancer are not eligible for enrollment: germ cell, sex cord stroma, or sarcoma.
* New York Heart Association Class III or IV cardiac disease, myocardial infarction within the past 6 months, or unstable arrhythmia.
* Fridericia-corrected QT interval (QTcF) > 470 msec (female) or history of congenital long QT syndrome.
* Active, uncontrolled bacterial, viral, or fungal infections, within 7 days of study entry requiring systemic therapy.
* Known to be human immunodeficiency virus (HIV) positive, have hepatitis B surface antigen (HBSAg), or hepatitis C antibodies (HCAb), unless hepatitis C virus ribonucleic acid (HCV RNA) undetected/negative.
* History of major organ transplant (i.e., heart, lungs, liver, or kidney).
* History of autologous/allogenic bone marrow transplant.
* Serious nonmalignant disease
* Pregnant or nursing.
* History of osteonecrosis of the hip or have evidence of structural bone abnormalities in the proximal femur on MRI scan that are symptomatic and clinically significant.
* Symptomatic central nervous system (CNS) malignancy or metastasis.
* Known osteoblastic bony metastasis
* Treatment with surgery or chemotherapy within 21 days prior to study entry (42 days for nitrosoureas or mitomycin C)
* Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to study entry.
* Clinically significant peripheral neuropathy at the time of study entry. Patients with pre-existing peripheral neuropathy will be allowed to receive single agent DKN-01
* History of hypersensitivity reactions to paclitaxel or other drugs formulated in Cremophor® EL (polyoxyethylated castor oil). Patients who exhibit these hypersensitivities will be eligible to receive single agent DKN-01
* Prior radiation therapy within 14 days prior to study entry
* Currently receiving any other investigational agent or received an investigational agent within last 30 days of study entry.
* Previously treated with an anti-DKK1 therapy
* Significant allergy to a pharmaceutical therapy that, in the opinion of the Investigator, poses an increased risk to the patient
* Active substance abuse
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT03395080
| 5,703
|
{
"NCT_ID" : "NCT02661945",
"Brief_Title" : "Usefulness of Near-focus With Narrow-band Imaging",
"Official_title" : "Usefulness of Near-focus With Narrow-band Imaging for Determining Gastric Tumor Margin",
"Conditions" : ["Gastric Tumors"],
"Interventions" : ["Device: Near focus with narrow band imaging"],
"Location_Countries" : ["Korea, Republic of"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "DIAGNOSTIC",
"Allocation" : "RANDOMIZED",
"Interventional Model" : "PARALLEL",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
Near-focus with narrow-band imaging is a novel technique to improve the quality of images of the irregular mucosal structures and microvessels of gastric neoplasms. The investigators compare this technique with indio carmin spray, commonly used tool to determine tumor margin. The subject are patients who underwent endoscopic submucosal dissection for gastric neoplasms. Participants are randomized into near-focus with narrow-band imaging and indigo carmin groups. First, marking is performed at the tumor margins determined by each modality. The distance from the marking dots to the tumor margin is measured histopathologically in the resected specimens. Finally, the investigators will compare the accuracy between two groups based on the distance from marking dots to tumor margin measured by histopathologic examination.
#Intervention
- DEVICE : Near focus with narrow band imaging
|
#Eligibility Criteria:
Inclusion Criteria:
* Participants who undergo endoscopic submucosal dissection for gastric tumors (early gastric carcinoma or gastric adenoma)
Exclusion Criteria:
* fail to en bloc resection
Sex :
ALL
Ages :
- Minimum Age : 19 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT02661945
| 38,311
|
{
"NCT_ID" : "NCT03941743",
"Brief_Title" : "Fingolimod in Preventing Paclitaxel-Associated Neuropathy in Patients With Breast Cancer",
"Official_title" : "Prevention of Paclitaxel-Associated Neuropathy With Fingolimod: a Pilot Trial",
"Conditions" : ["Breast Carcinoma"],
"Interventions" : ["Drug: Fingolimod", "Other: Questionnaire Administration", "Drug: Fingolimod Hydrochloride"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "PREVENTION",
"Allocation" : "NA",
"Interventional Model" : "SINGLE_GROUP",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
This trial phase I studies how well fingolimod works in preventing chemotherapy-induced nerve pain (neuropathy) in patients with breast cancer who are taking paclitaxel. Fingolimod acts by suppressing immune reactions in the brain. This study is being done to see if fingolimod can reduce neuropathy caused by paclitaxel.
Detailed Description
PRIMARY OBJECTIVES:
I. To obtain preliminary data to support whether fingolimod hydrochloride (fingolimod) will prevent chemotherapy-induced peripheral neuropathy (CIPN) in patients receiving weekly adjuvant/neoadjuvant paclitaxel therapy.
SECONDARY OBJECTIVES:
I. To obtain pilot data regarding the possible relative toxicities related to fingolimod therapy in this study situation.
OUTLINE:
Patients receive fingolimod hydrochloride orally (PO) once daily (QD) starting the day before chemotherapy, the day of chemotherapy, and 1 day after chemotherapy for 12 weeks.
After the completion of study, patients are followed up at 6, 12, and 18 months.
#Intervention
- DRUG : Fingolimod
- Given PO
- DRUG : Fingolimod Hydrochloride
- Given PO
- Other Names :
- FTY-720, FTY720, Gilenya
- OTHER : Questionnaire Administration
- Ancillary studies
|
#Eligibility Criteria:
Inclusion Criteria:
* Ability to complete questionnaires by themselves or with assistance.
* Paclitaxel at a dose of 80 mg/m^2 given every week for a scheduled course of 12 weeks for treating breast cancer.
* Life expectancy >= 6 months.
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1.
* Negative pregnancy test (serum or urine) done =< 14 days prior to registration, for persons of childbearing potential only.
* Provide written informed consent.
Exclusion Criteria:
* Previous exposure to paclitaxel (please note that it is acceptable for patients to receive non-neurotoxic chemotherapy, like doxorubicin hydrochloride (Adriamycin) and cyclophosphamide (AC), before or after the weekly paclitaxel and/or to receive concurrent anti-her 2 therapy).
* Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects:
* Pregnant persons
* Nursing persons
* Persons of childbearing potential who are unwilling to employ adequate contraception.
* Previous diagnosis of diabetic or other peripheral neuropathy.
* Current or previous use of fingolimod.
* History of the following preexisting conditions: ischemic heart disease, cardiac arrest, cerebrovascular disease, uncontrolled hypertension, symptomatic bradycardia, macular edema, recurrent syncope, severe untreated sleep apnea, herpes simplex virus (HSV), varicella zoster virus (VZV), chronic hepatitis, tuberculosis, fungal infections, skin cancer, or diabetes.
* Myocardial infarction, unstable angina, stroke, transient ischemic attack (TIA), decompensated heart failure requiring hospitalization or class III/IV heart failure < 6 months prior to registration.
* History or presence of Mobitz type II second-degree or third-degree atrioventricular (AV) block or sick sinus syndrome, unless patient has a functioning pacemaker.
* History of a hypersensitivity reaction to fingolimod or any of the excipients including rash, urticarial, and angioedema upon treatment initiation.
* Baseline corrected QT (QTC) interval >= 450 ms (on electrocardiography [EKG]).
* Concurrent use of a class Ia or III antiarrhythmic.
* Drugs with a known risk of torsades de pointes.
* Concurrent use of beta blockers, calcium channel blockers or digoxin.
* Use of immunosuppressive, or immune-modulating therapies that may have immunosuppressive effects.
* Immunocompromised patients including patients known to be human immunodeficiency virus (HIV) positive.
* Uncontrolled intercurrent illness including, but not limited to:
* Ongoing or active infection
* Unstable angina pectoris
* Cardiac arrhythmia
* Or psychiatric illness/social situations that would limit compliance with study requirements.
* Receiving any other investigational agent.
* Family history of a genetic/familial neuropathy.
* Received a vaccine (inactivated) =< 14 days prior to registration.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT03941743
| 21,569
|
{
"NCT_ID" : "NCT04881604",
"Brief_Title" : "Adjustable Compression Wrap Versus Compression Sleeve to Control Breast Cancer-related Lymphedema",
"Official_title" : "Compressive Therapy by Adjustable Compression Garment (Ready Wrap®) in Breast Cancer-related Lymphedema: Randomized Clinical Trial",
"Conditions" : ["Breast Cancer Related Lymphedema", "Lymphedema, Secondary", "Lymphedema of Upper Arm", "Breast Neoplasms"],
"Interventions" : ["Device: Adjustable Compression Wrap", "Device: Compression Sleeve"],
"Location_Countries" : ["Brazil"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional Model" : "PARALLEL",
"Masking" : "SINGLE"
}
}
|
#Study Description
Brief Summary
This is a randomized clinical trial, in which the use of an Adjustable compression wrap as a compressive therapy to control the upper limb volume of with lymphedema women secondary to breast cancer will be investigated, in comparison to the use of a compression sleeve conventionally used. It is expected that Adjustable compression wrap will be more effective than standard treatment for the control of lymphedema, in addition to promoting a better quality of life and functionality for women.
Detailed Description
This is a randomized clinical trial of medical devices in pivotal stage, simple blind, which aims to evaluate the effectiveness of the use of adjustable compression wrap in controlling the volume of the upper limb of women with lymphedema secondary to breast cancer. It will be carried out in a reference hospital in the treatment of breast cancer in Brazil, with inclusion scheduled for June 2021 and follow-up of up to 1 year.
All volunteers must have stabilized lymphedema in the upper limb secondary to breast cancer and, therefore indicated phase 2 of compressive therapy. According to the sample calculation will be needed72 women to be randomly randomized in a 1: 1 ratio between the experimental intervention group (n = 36) and the standard intervention group (n = 36).
The Intervention consists of compressive therapy in the control phase for lymphedema secondary to breast cancer, in which the Experimental Intervention Group will receive a Adjustable compression wrap (Read Wrap®) while the Standard Intervention Group will receive a standard compressive sleeve for use in the upper limb with lymphedema, according to the institutional routine. The institutional protocol for the lymphedema control phase will be respected, in which the orthosis is used at home for the longest possible period, with only removal for bathing and sleeping; furthermore, skin care and therapeutic exercises for the upper limbs must be performed daily. One guidance booklet and home exercises of the institutional routine will be delivered . During the initial 30 days of treatment, all study participants will be able to be accompanied by a telephone channel that will be provided for questions, guidance and communications of adverse events, in addition to a therapeutic diary that will be delivered at the first appointment and collected after this period, designed to notify relevant information that they consider about the use of compressive therapy such as facilities, difficulties and time of use, symptoms related to the arm and adverse effects that may arise, and to monitor adherence to exercises.
The suspension of treatment before the anticipated end of therapy will occur when adverse effects are observed, such as an increase in the volume of the limb greater than 10% of the last measurement, signs of dermatitis, skin infections or allergy. The case will be evaluated by the physiotherapy team and, when necessary, by the medical team and the necessary procedures will be adopted.
Data collection will take place through the analysis of physical and electronic medical records, interviews and physical examination. The interviews will consist of questionnaires produced by the researchers, in addition to validated questionnaires for the brazilian population. The evaluations will take place in the outpatient clinic of the physiotherapy service of the hospital on the 1st and 30th day of the intervention for immediate evaluation, and will be followed up until 1 years later, to verify the long-term outcome measures.
The analysis of the data will be descriptive and comparative of the intervention groups, in relation to the selected variables and the main outcomes, through the analysis of measures of central tendency, dispersion and frequency distribution. Outcome assessment will be performed by intention to treat, using linear and logistic regression, simple and multiple. For all analyzes the 95% confidence interval will be considered.
#Intervention
- DEVICE : Adjustable Compression Wrap
- Delivery, adaptation and guidance for daily use of the Adjustable Compression Wrap. (Ready Wrap® allows for easy use because to be pre-molded system in inelastic material with self-adjusting compressible components according to the size and shape of the upper limb. Due to its compressive properties, it can be used as therapy to control lymphedema. The material composition is: 61% Nylon, 33% Polyurethane, 6% Elastane (Spandex)).
The institutional protocol for the lymphedema control phase will be respected, in which the orthosis is used at home for the longest possible period, with only removal for bathing and sleeping; furthermore, skin care and therapeutic exercises for the upper limbs must be performed daily.
- DEVICE : Compression Sleeve
- Delivery, adaptation and guidance for daily use of the Compression sleeve. (Compression Sleeve is a mesh in the shape of a glove that provides compression on the fabrics needed to help control the volume of the limbs. Traditionally used for stage 2 of compressive therapy. The composition of the material is: 64% Nylon, 36% Elastane (Spandex) ).
The institutional protocol for the lymphedema control phase will be respected, in which the orthosis is used at home for the longest possible period, with only removal for bathing and sleeping; furthermore, skin care and therapeutic exercises for the upper limbs must be performed daily.
- Other Names :
- Compressive Mesh
|
#Eligibility Criteria:
Inclusion Criteria:
* Women
* Age > 18 years
* Undergo surgical treatment for breast cancer
* Diagnosed with lymphedema in the upper limb stabilized for a period >=6 months
* Indicated the second phase of compressive therapy / treatment of lymphedema
Exclusion Criteria:
* Women with:
* Bilateral lymphedema;
* Lymphedema since the preoperative period;
* Presence of phlogistic signs in the limb with lymphedema;
* Treatment of lymphedema (phase 1) in the last three months;
* Previous history of allergic reaction to the material used for compressive therapy;
* Active regional or remote disease;
* In chemotherapy or radiation therapy;
* Functional changes in the upper limbs prior to the diagnosis of breast cancer;
* Heart disease and decompensated systemic arterial hypertension; psychiatric, mental, neurological disorders or cognitive deficits that make it impossible to answer the questionnaires.
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT04881604
| 8,065
|
{
"NCT_ID" : "NCT01217437",
"Brief_Title" : "Temozolomide and Irinotecan Hydrochloride With or Without Bevacizumab in Treating Young Patients With Recurrent or Refractory Medulloblastoma or CNS Primitive Neuroectodermal Tumors",
"Official_title" : "Temozolomide With Irinotecan Versus Temozolomide, Irinotecan Plus Bevacizumab (NSC# 704865) for Recurrent/Refractory Medulloblastoma/CNS PNET of Childhood, a COG Randomized Phase II Screening Trial",
"Conditions" : ["Central Nervous System Neoplasm", "Pineoblastoma", "Recurrent Medulloblastoma", "Recurrent Primitive Neuroectodermal Tumor", "Refractory Medulloblastoma", "Refractory Peripheral Primitive Neuroectodermal Tumor"],
"Interventions" : ["Drug: Irinotecan Hydrochloride", "Biological: Bevacizumab", "Drug: Temozolomide"],
"Location_Countries" : ["Puerto Rico", "New Zealand", "Australia", "United States", "Canada"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional Model" : "PARALLEL",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
This randomized phase II trial studies how well giving temozolomide and irinotecan hydrochloride together with or without bevacizumab works in treating young patients with recurrent or refractory medulloblastoma or central nervous system (CNS) primitive neuroectodermal tumors. Drugs used in chemotherapy, such as temozolomide and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether temozolomide and irinotecan hydrochloride are more effective with or without bevacizumab in treating medulloblastoma or CNS primitive neuroectodermal tumors.
Detailed Description
PRIMARY OBJECTIVES:
l. To compare the overall survival (OS) of subjects receiving the combination of temozolomide and irinotecan with that of subjects receiving temozolomide, irinotecan (irinotecan hydrochloride), and bevacizumab for recurrent medulloblastoma (MB)/primitive neuroectodermal tumor (PNET) of childhood.
SECONDARY OBJECTIVES:
I. To assess the response rate for each treatment arm amongst patients who are enrolled with measurable disease.
II. To determine event-free survival (EFS) for each patient compared across regimens.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive temozolomide orally (PO) and irinotecan hydrochloride IV over 90 minutes on days 1-5.
ARM II: Patients receive temozolomide PO and irinotecan hydrochloride IV as in arm I and bevacizumab IV over 30-90 minutes on days 1 and 15.
In both arms, treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 5 years.
#Intervention
- BIOLOGICAL : Bevacizumab
- Given IV
- Other Names :
- ABP 215, Anti-VEGF, Anti-VEGF Humanized Monoclonal Antibody, Anti-VEGF rhuMAb, Avastin, Bevacizumab awwb, Bevacizumab Biosimilar ABP 215, Bevacizumab Biosimilar BEVZ92, Bevacizumab Biosimilar BI 695502, Bevacizumab Biosimilar CBT 124, Bevacizumab Biosimilar CT-P16, Bevacizumab Biosimilar FKB238, Bevacizumab Biosimilar GB-222, Bevacizumab Biosimilar HD204, Bevacizumab Biosimilar HLX04, Bevacizumab Biosimilar IBI305, Bevacizumab Biosimilar LY01008, Bevacizumab Biosimilar MIL60, Bevacizumab Biosimilar Mvasi, Bevacizumab Biosimilar MYL-1402O, Bevacizumab Biosimilar QL 1101, Bevacizumab Biosimilar RPH-001, Bevacizumab Biosimilar SCT501, Bevacizumab Biosimilar Zirabev, Bevacizumab-awwb, Bevacizumab-bvzr, BP102, BP102 Biosimilar, HD204, Immunoglobulin G1 (Human-Mouse Monoclonal rhuMab-VEGF Gamma-Chain Anti-Human Vascular Endothelial Growth Factor), Disulfide With Human-Mouse Monoclonal rhuMab-VEGF Light Chain, Dimer, Mvasi, MYL-1402O, Recombinant Humanized Anti-VEGF Monoclonal Antibody, rhuMab-VEGF, SCT501, Zirabev
- DRUG : Irinotecan Hydrochloride
- Given IV
- Other Names :
- Campto, Camptosar, Camptothecin 11, Camptothecin-11, CPT 11, CPT-11, Irinomedac, Irinotecan Hydrochloride Trihydrate, Irinotecan Monohydrochloride Trihydrate, U-101440E
- DRUG : Temozolomide
- Given PO
- Other Names :
- CCRG-81045, Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-, M & B 39831, M and B 39831, Methazolastone, RP-46161, SCH 52365, Temcad, Temodal, Temodar, Temomedac, TMZ
|
#Eligibility Criteria:
Inclusion Criteria:
* Medulloblastoma or PNET of childhood that has relapsed or become refractory to standard chemotherapy; patients with pineoblastoma are eligible
* Patients must have had histologic verification of the malignancy at original diagnosis or at the time of recurrence
* Patients must have clear residual disease, defined as tumor that is measurable in two perpendicular diameters on magnetic resonance imaging (MRI) OR diffuse leptomeningeal disease OR clear MRI evidence of disease that may not be measurable in two perpendicular diameters
* All patients must have a brain MRI with and without gadolinium and a spine MRI with gadolinium performed within 2 weeks prior to study enrollment
* Patients must have a Lansky or Karnofsky performance status score of >= 50%, corresponding to Eastern Cooperative Oncology Group (ECOG) categories of 0, 1, or 2 (use Karnofsky for patients > 16 years and Lansky for patients =< 16 years)
* Patients must have a life expectancy of >= 8 weeks
* Patients must have experienced at least one and at most two relapses prior to study enrollment; patients with primary refractory disease are eligible
* Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
* Myelosuppressive chemotherapy: Must not have received within 3 weeks of entry onto this study (6 weeks if prior nitrosourea)
* Biologic (anti-neoplastic agent): At least 7 days since the completion of therapy with a biologic agent; at least 3 weeks for biologic agents with a long half life, such as antibodies
* External beam radiation therapy (XRT): Must not have received craniospinal radiotherapy within 24 weeks prior to study entry; the tumor designated as 'measurable' for protocol purposes must not have received radiation within 12 weeks prior to study entry); focal radiation to areas of symptomatic metastatic disease must not be given within 14 days of study entry
* Stem cell transplant (SCT): For autologous SCT, >= 3 months must have elapsed prior to study entry
* Study specific limitations on prior therapy:
* Patients must not have previously received bevacizumab, irinotecan, temozolomide or other anti-vascular endothelial growth factor (VEGF) inhibitor
* Patients must not be taking enzyme-inducing antiepileptic medicines within 1 week of study entry
* Patients must have recovered from any surgical procedure before enrolling on this study:
* Patients with a major surgical procedure within 28 days prior to enrollment should be excluded
* Patients with an intermediate surgical procedure within 14 days prior to enrollment should be excluded
* For minor surgical procedures (including Broviac line or infusaport placement), patients should not receive the first planned dose of bevacizumab until the wound is healed and at least 7 days have elapsed
* There should be no anticipation of need for major surgical procedures during the course of the study
* Examples of major, intermediate, or minor surgical procedures:
* Major procedures: Major craniotomy for tumor resection; organ resection; bowel wall anastomosis; arteriovenous grafts; exploratory laparotomy; thoracotomy
* Intermediate procedures: Ventriculoperitoneal (VP)-shunt placement; stereotactic brain biopsy
* Minor procedures: Incision and drainage of superficial skin abscesses; punch biopsy of skin lesions; superficial skin wound suturing; bone marrow aspirate and/or biopsy; fine needle aspirations; Broviac line or infusaport placement; paracentesis or thoracocentesis
* Please note: Lumbar punctures or placement of peripherally inserted central catheter (PICC) lines are not considered minor procedures and may occur at any time prior to or during therapy
* Hypertension must be well controlled (=< 95th percentile for age and height if patient is =< 17 years) on stable doses of medication
* Concomitant medications restrictions:
* Growth factor(s): Must not have received within 7 days of entry onto this study
* Steroids: Patients who are receiving corticosteroids must be on a stable or decreasing dose for at least 7 days
* Study Specific: Patients must not be currently taking nonsteroidal anti-inflammatory drugs (NSAIDs), clopidrogel, dipyridamole or aspirin therapy > 81 mg/day
* Peripheral absolute neutrophil count (ANC) >= 1000/uL (must not have received filgrastim [G-CSF] within the prior 7 days)
* Platelet count >= 100,000/uL (transfusion independent)
* Hemoglobin >= 8.0 gm/dL (may receive packed red blood cell [PRBC] transfusions)
* Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min OR a serum creatinine based on age/gender as follows:
* =< 0.4 mg/dL (for patients aged 1 month to < 6 months)
* =< 0.5 mg/dL (for patients aged 6 months to < 1 year)
* =< 0.6 mg/dL (for patients aged 1 to < 2 years)
* =< 0.8 mg/dL (for patients aged 2 to < 6 years)
* =< 1 mg/dL (for patients aged 6 to < 10 years)
* =< 1.2 mg/dL (for patients aged 10 to < 13 years)
* =< 1.4 mg/dL (for female patients aged >= 13 years)
* =< 1.5 mg/dL (for male patients aged 13 to < 16 years)
* =< 1.7 mg/dL (for male patients aged >= 16 years)
* Urine protein should be screened by dipstick analysis; if protein >= 2+ on dipstick, then urine protein creatinine (UPC) ratio should be calculated; if UPC ratio > 0.5, 24-hour urine protein should be obtained and the level should be < 1000 mg/24 hours for patient enrollment
* Total bilirubin =< 1.5 x upper limit of normal (ULN) for age
* Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 3 x upper limit of normal (ULN) for age
* Central nervous system function defined as
* Patients with a seizure disorder may be enrolled if well-controlled and on non-enzyme inducing anticonvulsants
* Adequate coagulation defined as
* International normalized ratio (INR)/prothrombin time (PT) =< 1.5 x upper limit of normal
Exclusion Criteria:
* Patients with a serious or non-healing wound, ulcer, or bone fracture are not eligible for this study
* Patients must not have a history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months prior to study entry
* Patients must not have a known bleeding diathesis or coagulopathy
* Patients must not have had significant vascular disease (eg, aortic aneurysm requiring surgical repair, deep venous or arterial thrombosis) within the last 6 months prior to study entry
* Patients must not have a known thrombophilic condition (i.e. protein S, protein C or antithrombin III deficiency, Factor V Leiden, Factor II G20210A mutation, homocysteinemia or antiphospholipid antibody syndrome); testing is not required in patients without thrombophilic history
* Patients must not have evidence of new CNS hemorrhage on baseline MRI obtained within 14 days prior to study enrollment
* Patients with a history of stroke, myocardial infarction, transient ischemic attack (TIA), severe or unstable angina, peripheral vascular disease, or grade II or greater congestive heart failure within the past 6 months are not eligible
* Patients must not have serious and inadequately controlled cardiac arrhythmia
* Female patients who are pregnant are not eligible for this study
* Female patients who are breastfeeding are not eligible for this study unless they agree not to breastfeed
* Female patients of childbearing potential must have a negative pregnancy test
* Sexually active patients of childbearing potential must agree to use an effective method of contraception during the study and for at least 6 months after the completion of bevacizumab therapy
* Patients with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
Sex :
ALL
Ages :
- Maximum Age : 21 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT01217437
| 28,258
|
{
"NCT_ID" : "NCT01738646",
"Brief_Title" : "Ph II SAHA and Bevacizumab for Recurrent Malignant Glioma Patients",
"Official_title" : "Phase II Study of Bevacizumab and Vorinostat for Recurrent WHO Grade IV Malignant Glioma Patients",
"Conditions" : ["Recurrent Glioblastoma Multiforme", "Malignant Glioma", "Adult Brain Tumor"],
"Interventions" : ["Drug: Vorinostat", "Drug: Bevacizumab"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional Model" : "SINGLE_GROUP",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
It has been shown that bevacizumab has significant anti-tumor activity in patients with recurrent glioblastoma multiforme. Vorinostat has modest anti-tumor activity against malignant glioma and can enhance the action of both chemotherapy and anti-angiogenics. Patients will be treated with a combination of bevacizumab and vorinostat.
Detailed Description
There is no effective therapy for patients with recurrent glioblastoma multiforme (GBM) hence such patients remain a major unmet need in oncology. The investigators have recently demonstrated that bevacizumab (BV), a humanized monoclonal antibody against vascular endothelial growth factor, has significant anti-tumor activity among recurrent glioblastoma multiforme patients. Vorinostat has modest anti-tumor activity against malignant glioma and can potentiate the action of both chemotherapy and anti-angiogenics. The current study is designed to evaluate the anti-tumor activity of vorinostat when combined with BV among recurrent glioblastoma multiforme patients.
#Intervention
- DRUG : Vorinostat
- Other Names :
- SAHA
- DRUG : Bevacizumab
- Other Names :
- Avastin
|
#Eligibility Criteria:
Inclusion Criteria:
* Age > 18 years.
* An interval of at least 4 weeks between prior surgical resection or one week from stereotactic biopsy.
* An interval of at least 12 weeks from the end of prior radiotherapy unless there is a new area of enhancement consistent with recurrent tumor outside of the radiation field, or there is biopsy-proven tumor progression
* An interval of at least 4 weeks from prior chemotherapy [6 weeks for nitrosoureas, 1 week for daily administered chemotherapy (metronomic dosing)] or investigational agent unless the patient has recovered from all anticipated toxicities associated with that therapy.
* Eastern Cooperative Oncology Group (ECOG) 0 <= age <= 1.
* Hematocrit >= 29%, hemoglobin >= 9, absolute neutrophil >=1,500 cells/microliter, platelets >= 100,000 cells/microliters.
* Serum creatinine, serum glutamic oxaloacetic transaminase(SGOT) and bilirubin < 1.5 times upper limit of normal.
* Signed informed consent approved by the Institutional Review Board prior to patient entry.
* No evidence of hemorrhage on the baseline MRI or CT scan other than those that are stable grade 1.
* If sexually active, patients will take contraceptive measures for the duration of the treatments. Medically acceptable contraceptives include: (1) surgical sterilization (such as a tubal ligation, hysterectomy, vasectomy), (2) approved hormonal contraceptives (such as birth control pills, patches, implants or injections), (3) barrier methods (such as a condom or diaphragm) used with a spermicide, or (4) an intrauterine device (IUD).
Exclusion Criteria:
Disease-specific exclusions
* More than 2 prior episodes of disease progression
* Prior therapy with histone deacetylase inhibitors; valproic acid is not permitted and patients previously treated with valproic acid must be off valproic acid for at least 30 days prior to initiation of study medication
* Prior bevacizumab therapy
* Co-medication that may interfere with study results; e.g. immuno-suppressive agents other than corticosteroids
* Active infection requiring intravenous antibiotics
* Severe hepatic insufficiency, active viral hepatitis or HIV infection
* Requires therapeutic anti-coagulation with warfarin
General medical exclusions
Subjects meeting the following criteria are ineligible for study entry:
* Inability to comply with study and/or follow-up procedures
Bevacizumab-specific exclusions
* Inadequately controlled hypertension (defined as systolic blood pressure > 150 and/or diastolic blood pressure > 100 mmHg on antihypertensive medications)
* Any prior history of hypertensive crisis or hypertensive encephalopathy
* New York Heart Association (NYHA) Grade II or greater congestive heart failure (see Appendix E)
* History of myocardial infarction or unstable angina within 6 months prior to study enrollment
* History of stroke or transient ischemic attack within 6 months prior to study enrollment
* Significant vascular disease (e.g., aortic aneurysm, aortic dissection)
* Symptomatic peripheral vascular disease
* Evidence of bleeding diathesis or coagulopathy
* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrollment or anticipation of need for major surgical procedure during the course of the study
* Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to study enrollment
* History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment
* Serious, non-healing wound, ulcer, or bone fracture
* Proteinuria at screening as demonstrated by either:
* Urine protein:creatinine (UPC) ratio >= 1.0 at screening OR
* Urine dipstick for proteinuria >= 2+ (patients discovered to have >=2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate <= 1g of protein in 24 hours to be eligible).
* Known hypersensitivity to any component of bevacizumab
* Pregnant (positive pregnancy test) or lactating. Refuse the use of effective means of contraception (men and women) in subjects of child-bearing potential
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 120 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT01738646
| 14,452
|
{
"NCT_ID" : "NCT02086968",
"Brief_Title" : "Treatment Response of Injectafer vs Oral Iron to Baseline Hepcidin Levels in Patients With Iron Deficiency Anemia (IDA) Secondary to Inflammatory Bowel Disease (IBD) or Gastric Bypass",
"Official_title" : "Multicenter Randomized Open-label Controlled Study to Investigate Treatment Response of IV Injectafer vs Oral Iron to Baseline Hepcidin Levels in Patients With Iron Deficiency Anemia Secondary to Inflammatory Bowel Disease or Gastric Bypass",
"Conditions" : ["Iron Deficiency Anemia Secondary to IBD or Gastric Bypass"],
"Interventions" : ["Drug: Ferrous Sulfate tablets", "Drug: Injectafer"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE4"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional Model" : "PARALLEL",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
The primary objective of this study is to evaluate the treatment response of Injectafer vs. oral iron to baseline hepcidin levels to determine if any of these select IBD or Gastric Bypass patients may demonstrate to be inappropriate for oral iron therapy.
Detailed Description
The primary objective of this study is to evaluate the treatment response of Injectafer vs. oral iron in patients with varying hepcidin levels correlating the treatment response/hepcidin levels to more common laboratory parameters such as ferritin and CRP (C-Reactive Protein) levels and possibly determine if any of these select IBD or Gastric Bypass patients may demonstrate to be inappropriate for oral iron therapy.
#Intervention
- DRUG : Injectafer
- 2 doses of Injectafer, at 15mg/kg for a maximum single dose of 750mg given on days 0 and 7 for a total of up to 1500mg
- Other Names :
- Ferric Carboxymaltose (FCM)
- DRUG : Ferrous Sulfate tablets
- 325mg (1 tablet) three times a day for 28 days
- Other Names :
- Oral Iron tablets
|
#Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent
* Male or female subjects >= 18 years with clinical diagnosis of IDA secondary to IBD or Gastric Bypass
* Screening Hemoglobin (Hb) <= 11g/dL
* Screening Ferritin <= 100 ng/mL
* Female subjects who are of childbearing age must have a negative pregnancy test at screening and be practicing an acceptable method of birth control during the study
Exclusion Criteria:
* Hypersensitivity reaction to any component of IV Injectafer or oral iron
* Requires dialysis for treatment of chronic kidney disease (CKD)
* During the 30 day period prior to screening has been treated with IV iron
* No evidence of iron deficiency
* During the 30 day period prior to screening has been treated with a red blood cell transfusion.
* Any non-viral infection
* Known positive hepatitis with evidence of active disease
* Received an investigational drug within 30 days of screening
* Active malignancy within 5 years. Basal or squamous cell skin cancer is not exclusionary
* Alcohol or drug abuse within the past 6 months
* Hemochromatosis or other iron storage disorders
* Pregnant
* Any other laboratory abnormality, medical condition, or psychiatric disorders which in the opinion of the Investigator would put the subject's disease management at risk or may result in the subject being unable to comply with the study requirements
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT02086968
| 15,325
|
{
"NCT_ID" : "NCT02808442",
"Brief_Title" : "Study of UCART19 in Pediatric Patients With Relapsed/Refractory B Acute Lymphoblastic Leukemia",
"Official_title" : "A Phase 1, Open Label, Non-comparative Study to Evaluate the Safety and the Ability of UCART19 to Induce Molecular Remission in Paediatric Patients With Relapsed/Refractory B-cell Acute Lymphoblastic Leukaemia",
"Conditions" : ["Refractory B-cell Acute Lymphoblastic Leukemia", "Relapsed B-cell Acute Lymphoblastic Leukemia"],
"Interventions" : ["Biological: UCART19"],
"Location_Countries" : ["France", "United Kingdom", "Spain", "United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional Model" : "SINGLE_GROUP",
"Masking" : "NONE"
}
}
|
#Study Description
Brief Summary
This study aims to evaluate the safety and feasibility of UCART19 to induce molecular remission in pediatric patients with relapsed or refractory CD19-positive B-cell acute lymphoblastic leukemia (B-ALL).
#Intervention
- BIOLOGICAL : UCART19
- Other Names :
- S68587
|
#Eligibility Criteria:
Inclusion Criteria:
* Patient with relapsed or refractory CD19-positive B-acute lymphoblastic leukaemia (B-ALL) who have exhausted alternative treatment options.
* Estimated life expectancy >= 12 weeks
* Lansky (age < 16 years at the time of assent/consent) or Karnofsky (age >= 16 years at time of assent/consent) performance status >= 50
Exclusion Criteria:
* Burkitt leukemia
* CD19-negative B-cell leukemia
* Active Central Nervous System (CNS) leukemia
* Active acute or chronic Graft-versus-Host Disease (GvHD) requiring systemic use therapy within 4 weeks before UCART19 infusion
* Patients with autoimmune disease requiring systemic immunosuppression therapy that cannot be stopped
* History of CRS grade 4 related to previous CAR T cell therapy
* Contraindication to Alemtuzumab administration
Sex :
ALL
Ages :
- Maximum Age : 17 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT02808442
| 27,558
|
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