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Sponsors and Collaborators: |
Southwest Oncology Group National Cancer Institute (NCI) Eastern Cooperative Oncology Group Cancer and Leukemia Group B |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005090 |
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.
Condition | Intervention | Phase |
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Lymphoma |
Biological: bleomycin sulfate Drug: ABVD regimen Drug: carmustine Drug: cyclophosphamide Drug: dacarbazine Drug: doxorubicin hydrochloride Drug: etoposide Drug: vinblastine Procedure: peripheral blood stem cell transplantation |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
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 |
Study Start Date: | April 2000 |
OBJECTIVES:
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.
PROJECTED ACCRUAL: Approximately 460 patients will be accrued for this study within 4 years.
Ages Eligible for Study: | 15 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed stage III or IV Hodgkin's disease with at least 3 of the following characteristics:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Study Chair: | Ellen R. Gaynor, MD | Loyola University |
Study Chair: | Sandra J. Horning, MD | Stanford University |
Study Chair: | Linda J. Burns, MD | Masonic Cancer Center, University of Minnesota |
Study ID Numbers: | CDR0000067708, SWOG-S9901, CLB-59802, E-S9901 |
Study First Received: | April 6, 2000 |
Last Updated: | April 18, 2009 |
ClinicalTrials.gov Identifier: | NCT00005090 History of Changes |
Health Authority: | United States: Federal Government |
stage III adult Hodgkin lymphoma stage IV adult Hodgkin lymphoma |
Immunoproliferative Disorders Dacarbazine Immunologic Factors Hodgkin Lymphoma, Adult Carmustine Hodgkin's Disease Vinblastine Antimitotic Agents Cyclophosphamide Immunosuppressive Agents Bleomycin Etoposide phosphate |
Doxorubicin Anti-Bacterial Agents Lymphatic Diseases Tubulin Modulators Antineoplastic Agents, Alkylating Antirheumatic Agents Lymphoproliferative Disorders Antineoplastic Agents, Phytogenic Alkylating Agents Lymphoma Hodgkin Disease Etoposide |
Dacarbazine Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Vinblastine Cyclophosphamide Antibiotics, Antineoplastic Therapeutic Uses Lymphoma Hodgkin Disease Alkylating Agents Immunoproliferative Disorders Neoplasms by Histologic Type Immune System Diseases |
Mitosis Modulators Carmustine Antimitotic Agents Bleomycin Immunosuppressive Agents Doxorubicin Pharmacologic Actions Lymphatic Diseases Neoplasms Tubulin Modulators Myeloablative Agonists Antineoplastic Agents, Alkylating Lymphoproliferative Disorders Antirheumatic Agents Antineoplastic Agents, Phytogenic |