S9901 Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Men With Stage III or Stage IV Hodgkin's Disease
- Conditions
- Lymphoma
- Interventions
- Biological: bleomycin sulfateProcedure: peripheral blood stem cell transplantation
- Registration Number
- NCT00005090
- Lead Sponsor
- SWOG Cancer Research Network
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. It is not yet known if combination chemotherapy is more effective with or without peripheral stem cell transplantation in treating Hodgkin's Disease.
PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without peripheral stem cell transplantation in treating men who have stage III or stage IV Hodgkin's disease.
- Detailed Description
OBJECTIVES:
* Compare progression-free and overall survival of patients with stage III or IV Hodgkin's disease treated with doxorubicin, bleomycin, vinblastine, and dacarbazine with or without autologous peripheral blood stem cell transplantation and high-dose chemotherapy.
* Compare the toxic effects of these treatment regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to number of poor prognostic factors (3 vs 4 vs 5) and stage of disease (III vs IV).
Patients receive induction chemotherapy consisting of doxorubicin IV over 5 minutes, bleomycin IV over 10 minutes, vinblastine IV over 5 minutes, and dacarbazine IV over 15-30 minutes on days 1 and 15. Treatment repeats every 28 days for 5 courses in the absence of disease progression or unacceptable toxicity. Patients who show at least partial response after the fifth course of induction chemotherapy and whose blood counts have recovered are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive 3 additional courses of induction chemotherapy for a total of 8 courses.
* Arm II: Patients receive 1 additional course of induction chemotherapy followed by stem cell collection. Patients then receive high-dose chemotherapy with carmustine IV over 2 hours on days -6 to -4, etoposide IV over 4 hours on day -4, and cyclophosphamide IV on day -2. Patients undergo autologous peripheral blood stem cell transplantation on day 0.
Patients are followed at 60 days, every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 460 patients will be accrued for this study within 4 years.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 11
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ABVD x 5 + ABVD x 1 + HDT + PBSCT bleomycin sulfate Patients receive 5 28-day cycles of ABVD (doxorubicin 25 mg/m\^2, bleomycin 10 U/m\^2, vinblastine 6 mg/m\^2, dacarbazine 375 mg/m\^2 all on days 1 and 15). Patients with no disease progression are then randomized to either 3 more cycles of ABVD or 1 more cycle of ABVD + high-dose therapy + stem cell transplant. Patients randomized to the transplant arm have 2 x 10\^6 CD34+ blood mononuclear cells/kg of actual body weight collected at day -7. High dose therapy consists of BCNU 150/m\^2 on days -6 to -4, etoposide 60 mg/kg on day -4, and cyclophosphamide 100 mg/kg on day -2. Peripheral blood stem cells are infused on day 0. ABVD x 5 + ABVD x 3 bleomycin sulfate Patients receive 5 28-day cycles of ABVD (doxorubicin 25 mg/m\^2, bleomycin 10 U/m\^2, vinblastine 6 mg/m\^2, dacarbazine 375 mg/m\^2 all on days 1 and 15). Patients with no disease progression are then randomized to either 3 more cycles of ABVD or 1 more cycle of ABVD + high-dose therapy + stem cell transplant. ABVD x 5 + ABVD x 1 + HDT + PBSCT peripheral blood stem cell transplantation Patients receive 5 28-day cycles of ABVD (doxorubicin 25 mg/m\^2, bleomycin 10 U/m\^2, vinblastine 6 mg/m\^2, dacarbazine 375 mg/m\^2 all on days 1 and 15). Patients with no disease progression are then randomized to either 3 more cycles of ABVD or 1 more cycle of ABVD + high-dose therapy + stem cell transplant. Patients randomized to the transplant arm have 2 x 10\^6 CD34+ blood mononuclear cells/kg of actual body weight collected at day -7. High dose therapy consists of BCNU 150/m\^2 on days -6 to -4, etoposide 60 mg/kg on day -4, and cyclophosphamide 100 mg/kg on day -2. Peripheral blood stem cells are infused on day 0. ABVD x 5 + ABVD x 3 doxorubicin hydrochloride Patients receive 5 28-day cycles of ABVD (doxorubicin 25 mg/m\^2, bleomycin 10 U/m\^2, vinblastine 6 mg/m\^2, dacarbazine 375 mg/m\^2 all on days 1 and 15). Patients with no disease progression are then randomized to either 3 more cycles of ABVD or 1 more cycle of ABVD + high-dose therapy + stem cell transplant. ABVD x 5 + ABVD x 3 dacarbazine Patients receive 5 28-day cycles of ABVD (doxorubicin 25 mg/m\^2, bleomycin 10 U/m\^2, vinblastine 6 mg/m\^2, dacarbazine 375 mg/m\^2 all on days 1 and 15). Patients with no disease progression are then randomized to either 3 more cycles of ABVD or 1 more cycle of ABVD + high-dose therapy + stem cell transplant. ABVD x 5 + ABVD x 3 vinblastine Patients receive 5 28-day cycles of ABVD (doxorubicin 25 mg/m\^2, bleomycin 10 U/m\^2, vinblastine 6 mg/m\^2, dacarbazine 375 mg/m\^2 all on days 1 and 15). Patients with no disease progression are then randomized to either 3 more cycles of ABVD or 1 more cycle of ABVD + high-dose therapy + stem cell transplant. ABVD x 5 + ABVD x 1 + HDT + PBSCT carmustine Patients receive 5 28-day cycles of ABVD (doxorubicin 25 mg/m\^2, bleomycin 10 U/m\^2, vinblastine 6 mg/m\^2, dacarbazine 375 mg/m\^2 all on days 1 and 15). Patients with no disease progression are then randomized to either 3 more cycles of ABVD or 1 more cycle of ABVD + high-dose therapy + stem cell transplant. Patients randomized to the transplant arm have 2 x 10\^6 CD34+ blood mononuclear cells/kg of actual body weight collected at day -7. High dose therapy consists of BCNU 150/m\^2 on days -6 to -4, etoposide 60 mg/kg on day -4, and cyclophosphamide 100 mg/kg on day -2. Peripheral blood stem cells are infused on day 0. ABVD x 5 + ABVD x 1 + HDT + PBSCT cyclophosphamide Patients receive 5 28-day cycles of ABVD (doxorubicin 25 mg/m\^2, bleomycin 10 U/m\^2, vinblastine 6 mg/m\^2, dacarbazine 375 mg/m\^2 all on days 1 and 15). Patients with no disease progression are then randomized to either 3 more cycles of ABVD or 1 more cycle of ABVD + high-dose therapy + stem cell transplant. Patients randomized to the transplant arm have 2 x 10\^6 CD34+ blood mononuclear cells/kg of actual body weight collected at day -7. High dose therapy consists of BCNU 150/m\^2 on days -6 to -4, etoposide 60 mg/kg on day -4, and cyclophosphamide 100 mg/kg on day -2. Peripheral blood stem cells are infused on day 0. ABVD x 5 + ABVD x 1 + HDT + PBSCT dacarbazine Patients receive 5 28-day cycles of ABVD (doxorubicin 25 mg/m\^2, bleomycin 10 U/m\^2, vinblastine 6 mg/m\^2, dacarbazine 375 mg/m\^2 all on days 1 and 15). Patients with no disease progression are then randomized to either 3 more cycles of ABVD or 1 more cycle of ABVD + high-dose therapy + stem cell transplant. Patients randomized to the transplant arm have 2 x 10\^6 CD34+ blood mononuclear cells/kg of actual body weight collected at day -7. High dose therapy consists of BCNU 150/m\^2 on days -6 to -4, etoposide 60 mg/kg on day -4, and cyclophosphamide 100 mg/kg on day -2. Peripheral blood stem cells are infused on day 0. ABVD x 5 + ABVD x 1 + HDT + PBSCT doxorubicin hydrochloride Patients receive 5 28-day cycles of ABVD (doxorubicin 25 mg/m\^2, bleomycin 10 U/m\^2, vinblastine 6 mg/m\^2, dacarbazine 375 mg/m\^2 all on days 1 and 15). Patients with no disease progression are then randomized to either 3 more cycles of ABVD or 1 more cycle of ABVD + high-dose therapy + stem cell transplant. Patients randomized to the transplant arm have 2 x 10\^6 CD34+ blood mononuclear cells/kg of actual body weight collected at day -7. High dose therapy consists of BCNU 150/m\^2 on days -6 to -4, etoposide 60 mg/kg on day -4, and cyclophosphamide 100 mg/kg on day -2. Peripheral blood stem cells are infused on day 0. ABVD x 5 + ABVD x 1 + HDT + PBSCT etoposide Patients receive 5 28-day cycles of ABVD (doxorubicin 25 mg/m\^2, bleomycin 10 U/m\^2, vinblastine 6 mg/m\^2, dacarbazine 375 mg/m\^2 all on days 1 and 15). Patients with no disease progression are then randomized to either 3 more cycles of ABVD or 1 more cycle of ABVD + high-dose therapy + stem cell transplant. Patients randomized to the transplant arm have 2 x 10\^6 CD34+ blood mononuclear cells/kg of actual body weight collected at day -7. High dose therapy consists of BCNU 150/m\^2 on days -6 to -4, etoposide 60 mg/kg on day -4, and cyclophosphamide 100 mg/kg on day -2. Peripheral blood stem cells are infused on day 0. ABVD x 5 + ABVD x 1 + HDT + PBSCT vinblastine Patients receive 5 28-day cycles of ABVD (doxorubicin 25 mg/m\^2, bleomycin 10 U/m\^2, vinblastine 6 mg/m\^2, dacarbazine 375 mg/m\^2 all on days 1 and 15). Patients with no disease progression are then randomized to either 3 more cycles of ABVD or 1 more cycle of ABVD + high-dose therapy + stem cell transplant. Patients randomized to the transplant arm have 2 x 10\^6 CD34+ blood mononuclear cells/kg of actual body weight collected at day -7. High dose therapy consists of BCNU 150/m\^2 on days -6 to -4, etoposide 60 mg/kg on day -4, and cyclophosphamide 100 mg/kg on day -2. Peripheral blood stem cells are infused on day 0.
- Primary Outcome Measures
Name Time Method Progression-free survival every 3 months while on protocol treatment, then every 6 months for 2 years, then annually thereafter
- Secondary Outcome Measures
Name Time Method overall survival every 3 months while on treatment, then every 6 months thereafter
Trial Locations
- Locations (47)
Veterans Affairs Medical Center - Birmingham
🇺🇸Birmingham, Alabama, United States
University of California San Diego Cancer Center
🇺🇸La Jolla, California, United States
Veterans Affairs Medical Center - San Francisco
🇺🇸San Francisco, California, United States
UCSF Cancer Center and Cancer Research Institute
🇺🇸San Francisco, California, United States
CCOP - Christiana Care Health Services
🇺🇸Wilmington, Delaware, United States
Lombardi Cancer Center
🇺🇸Washington, District of Columbia, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
CCOP - Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
🇺🇸Chicago, Illinois, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Scroll for more (37 remaining)Veterans Affairs Medical Center - Birmingham🇺🇸Birmingham, Alabama, United States