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Phase II-III Chemotherapy with BLEO/DTIC/VBL/ADR/PRED or NM/VCR/PCB/PRED Plus Radiotherapy for Advanced Hodgkin's Disease
Basic Trial Information
Objectives I. Compare the remission-induction capability of BAVIP (bleomycin, DTIC, vinblastine, adriamycin, prednisone) vs. MOPP (nitrogen mustard, vincristine, procarbazine, prednisone). II. Determine if the complete remission rate and disease-free survival can be improved by the sequential use of two remission-induction regimens, MOPP and BAVIP. III. Determine the effectiveness and tolerability of intensive chemotherapy for 12 months followed by radiation. Entry Criteria Disease Characteristics: See General Eligibility Criteria Patient Characteristics: See General Eligibility Criteria General Eligibility Criteria: Advanced Hodgkin's disease, previously untreated by chemotherapy, Stages IVA or IVB. Stages IIB and IIIB are eligible in specific circumstances, but are separately stratified and randomized. Staging must be by lymphangiogram and laparoscopy, histological classification (Lukes-Butler systems) reviewed at the DFCI. Expected Enrollment Protocol closed 09/78. Outline Randomized study. Arm I: Sequential Combination Chemotherapy and Hormone Therapy with MOPP, followed by BAVIP, followed by Radiotherapy. MOPP - Nitrogen mustard, NM, NSC-762; Vincristine, VCR, NSC-67574; Procarbazine (PCB, NSC-77213); Prednisone, PRED, NSC-10023; followed by BAVIP - Bleomycin, BLEO, NSC-125066; DTIC, NSC-45388; Vinblastine, VBL, NSC-49642; Adriamycin, ADR, NSC-123127; Prednisone,(PRED, NSC-10023, followed by radiotherapy for patients in complete remission. Arm II: Sequential Combination Chemotherapy and Hormone Therapy with BAVIP followed by MOPP followed by radiotherapy. Trial Lead Organizations Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
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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