S9901 Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Men With Stage III or Stage IV Hodgkin's Disease
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About
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.
Full 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.
Enrollment
Sex
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Volunteers
Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
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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
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Bidimensionally measurable disease
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Bilateral or unilateral bone marrow aspiration and biopsy performed within 42 days of study
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Negative chest x-ray within 42 days of study OR
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Chest x-ray performed within 28 days of study
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Negative CT scan of thorax, abdomen, and pelvis within 42 days of study OR
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CT scan of thorax, abdomen, and pelvis performed within 28 days of study
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No history of lymphoma, myelodyplastic syndrome, or leukemia
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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)
Trial design
Primary purpose
Allocation
Interventional model
Masking
11 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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