S9901 Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Men With Stage III or Stage IV Hodgkin's Disease
Lymphoma
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring stage III adult Hodgkin lymphoma, stage IV adult Hodgkin lymphoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed stage III or IV Hodgkin's disease with at least 3 of the following characteristics: Albumin less than 4.0 mg/dL Hemoglobin less than 10.5 g/dL Leukocytosis at least 15,000/mm^3 Lymphocytopenia less than 600/mm^3 or less than 8% of total WBC Male sex At least 45 years of age Stage IV disease Bidimensionally measurable disease Bilateral or unilateral bone marrow aspiration and biopsy performed within 42 days of study Negative chest x-ray within 42 days of study OR Chest x-ray performed within 28 days of study Negative CT scan of thorax, abdomen, and pelvis within 42 days of study OR CT scan of thorax, abdomen, and pelvis performed within 28 days of study No history of lymphoma, myelodyplastic syndrome, or leukemia No CNS involvement by Hodgkin's disease PATIENT CHARACTERISTICS: Age: 15 to 65 Performance status: Zubrod 0-1 Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: See Disease Characteristics Bilirubin no greater than 1.5 times upper limit of normal (ULN) (unless elevation due to liver infiltration by Hodgkin's disease) Lymphoma-related hepatic dysfunction allowed Renal: Creatinine no greater than 2.0 times ULN Creatinine clearance at least 60 mL/min Lymphoma-related renal dysfunction allowed Cardiovascular: No coronary artery disease, cardiomyopathy, congestive heart failure, or arrhythmias requiring therapy Ejection fraction normal No significant EKG abnormalities suggesting active cardiac disease Pulmonary: Corrected DLCO at least 60% OR FEV1 at least 60% predicted Other: Not pregnant or nursing Fertile patients must use effective contraception No HIV or AIDS No other prior malignancy within past 5 years except adequately treated basal cell or squamous cell skin cancer No active bacterial, fungal, or viral infection* Afebrile for 3 consecutive days* NOTE: *Prior to randomization portion of study PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for Hodgkin's disease except single course of ABVD (doxorubicin, bleomycin, vinblastine, and dacarbazine) within 35 days of study Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy for Hodgkin's disease Surgery: Not specified Other: At least 3 days since prior antibiotics, antifungals, or antivirals (except for prophylactic therapy or fever associated with underlying lymphoma) (for randomization portion of study)
Sites / Locations
- Veterans Affairs Medical Center - Birmingham
- University of California San Diego Cancer Center
- Veterans Affairs Medical Center - San Francisco
- UCSF Cancer Center and Cancer Research Institute
- CCOP - Christiana Care Health Services
- Lombardi Cancer Center
- Walter Reed Army Medical Center
- CCOP - Mount Sinai Medical Center
- Veterans Affairs Medical Center - Chicago (Westside Hospital)
- University of Chicago Cancer Research Center
- Holden Comprehensive Cancer Center at The University of Iowa
- Veterans Affairs Medical Center - Togus
- Marlene & Stewart Greenebaum Cancer Center, University of Maryland
- Dana-Farber Cancer Institute
- University of Massachusetts Memorial Medical Center
- Veterans Affairs Medical Center - Minneapolis
- University of Minnesota Cancer Center
- Veterans Affairs Medical Center - Columbia (Truman Memorial)
- Ellis Fischel Cancer Center - Columbia
- Barnes-Jewish Hospital
- University of Nebraska Medical Center
- CCOP - Southern Nevada Cancer Research Foundation
- Norris Cotton Cancer Center
- Veterans Affairs Medical Center - Buffalo
- Roswell Park Cancer Institute
- CCOP - North Shore University Hospital
- Schneider Children's Hospital at North Shore
- Memorial Sloan-Kettering Cancer Center
- New York Presbyterian Hospital - Cornell Campus
- Mount Sinai Medical Center, NY
- State University of New York - Upstate Medical University
- Veterans Affairs Medical Center - Syracuse
- CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
- Lineberger Comprehensive Cancer Center, UNC
- Veterans Affairs Medical Center - Durham
- Duke Comprehensive Cancer Center
- CCOP - Southeast Cancer Control Consortium
- Comprehensive Cancer Center at Wake Forest University
- Arthur G. James Cancer Hospital - Ohio State University
- Rhode Island Hospital
- University of Tennessee, Memphis Cancer Center
- Veterans Affairs Medical Center - Memphis
- Green Mountain Oncology Group
- Vermont Cancer Center
- Veterans Affairs Medical Center - White River Junction
- Veterans Affairs Medical Center - Richmond
- MBCCOP - Massey Cancer Center
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
ABVD x 5 + ABVD x 3
ABVD x 5 + ABVD x 1 + HDT + PBSCT
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 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.