S9901 Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Men With Stage III or Stage IV Hodgkin's Disease

• Status: Terminated
• Trial end date: 2005-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Southwest Oncology Group
• Collaborators: Cancer and Leukemia Group B; Eastern Cooperative Oncology Group; National Cancer Institute (NCI)
• Treatments: Bleomycin; Carmustine; Cyclophosphamide; Dacarbazine; Doxorubicin; Etoposide; Etoposide phosphate; Liposomal doxorubicin; Vinblastine

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)