A Randomized Phase III Trial Comparing Early High Dose Chemotherapy and an Autologous Stem Cell Transplant to Conventional Dose ABVD Chemotherapy for Patients With Advanced Stage Poor Prognosis Hodgkin's Disease as Defined by the International Prognostic Factors Project on Advanced Hodgkin's Disease

Date de début de l'étude : 1 avril 2000

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)