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Phase II-III Chemotherapy with ADR/VCR/ARA-C plus Immunotherapy with BCG and Irradiated Cells for Acute Myelogenous Leukemia
Basic Trial Information
Objectives I. Determine the efficacy of combination chemotherapy with ADR/VCR/ARA-C in Phase II treatment of acute myelogenous leukemia. II. Determine the influence of reinforcement therapy with ADR/ARA-C on the duration of remission in a Phase III study. III. Determine the differences in extent of remissions obtained with immunotherapy alone, chemotherapy alone or with combination chemoimmunotherapy. IV. Investigate whether partial responders following three remission induction courses may be brought into complete remission by prolongation of the induction course. Entry Criteria Disease Characteristics: See General Eligibility Criteria Patient Characteristics: See General Eligibility Criteria General Eligibility Criteria: Patients less than 60 years of age with acute myelogenous leukemia. Patients may be in early stages of the disease and may have more than 30% blast cells in the bone marrow. Expected Enrollment Protocol closed. Outline Study randomized for Reinforcement and Maintenance. Enter all patients to Induction. Complete responders are randomized to Arms I and II. Responders are then rerandomized to Maintenance Arms III, IV, and V. Induction: 3-Drug Combination Chemotherapy. Adriamycin, ADR, NSC-123127; Vincristine, VCR, NSC-67574; Cytosine arabinoside, ARA-C, NSC-63878. Reinforcement: Arm I: 2-Drug Combination Chemotherapy. ADR; ARA-C. Arm II: Control. No Reinforcement Therapy. Maintenance: Arm III: Immunotherapy. Pasteur BCG, BCG, NSC-B116328, plus irradiated leukemic cells. Arm IV: 2-Drug Combination Chemotherapy. Cyclophosphamide, CTX, NSC-26271; CCNU, NSC-79037. Arm V: 2-Drug Combination Chemotherapy plus Immunotherapy. CTX; CCNU; plus BCG and irradiated leukemic cells. Trial Lead Organizations European Organization for Research and Treatment of Cancer
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. |
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