Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	15 to 65	NCI	SWOG-S9901 CLB-59802, E-S9901, NCT00005090, S9901

Objectives

1. 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.
2. Compare the toxic effects of these treatment regimens in these patients.

Entry 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/mm³
  • Lymphocytopenia less than 600/mm³ 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

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)

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]

Expected Enrollment

Approximately 460 patients will be accrued for this study within 4 years.

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.

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Ellen Gaynor, MD, Protocol chair		Ph: 708-327-3101

Eastern Cooperative Oncology Group

Sandra Horning, MD, Protocol chair		Ph: 650-725-6456; 800-756-9000

Cancer and Leukemia Group B

Linda Burns, MD, Protocol chair		Ph: 612-624-8144; 888-226-2376

Registry Information
Official Title		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
Trial Start Date		2000-04-15
Registered in ClinicalTrials.gov		NCT00005090
Date Submitted to PDQ		2000-02-29
Information Last Verified		2007-06-12
NCI Grant/Contract Number		CA32102