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Phase III Chemotherapy with NM/VCR/PCB/PRED and Low-Dose BLEO for Hodgkin's Disease Stages IIIB, IVA and IVB
Basic Trial Information
Objectives I. Determine the effectiveness of MOPP (nitrogen mustard, vincristine, procarbazine, prednisone) alone and in combination with low-dose bleomycin for complete remission induction in patients with disseminated Hodgkin's disease (stages IIIB, IVA, IVB). II. Determine the relative effectiveness of MOPP and radiation therapy (to the area of major disease involvement prior to MOPP) followed by MOPP and more intensive MOPP dosage schedule for remission consolidation in those patients achieving complete remission. Entry Criteria Disease Characteristics: See General Eligibility Criteria Patient Characteristics: See General Eligibility Criteria General Eligibility Criteria: Patients with demonstrable stages IIIB, IVA, or IVB Hodgkin's disease. Patients must have adequate bone marrow reserve. Expected Enrollment Protocol closed 08/74. Outline Randomized study. Induction: Nonrandomized treatment. Enter patients with compromised pulmonary function to Arm I, enter all other patients to Arm II (Amendment 2, June, 1973). Arm I: 3-Drug Combination Chemotherapy and Hormone Therapy (MOPP). Nitrogen mustard, NM, NSC-762; Vincristine, VCR, NSC-67574; Procarbazine, PCB, NSC-77213; Prednisone, PRED, NSC-10023. Arm II: 3-Drug Combination Chemotherapy and Hormone Therapy with MOPP. NM; VCR; PCB; PRED; plus low-dose Bleomycin, BLEO, NSC-125066. Consolidation. Randomized treatment. Randomize patients with complete remission to Arms III, IV and V. Arm III: 3-Drug Combination Chemotherapy and Hormone Therapy with MOPP. NM; VCR; PCB; PRED. Arm IV: Radiotherapy followed by 3-Drug Combination Chemotherapy and Hormone Therapy with MOPP. NM; VCR; PCB; PRED. Arm V: Intensive 3-Drug Combination Chemotherapy and Hormone Therapy with MOPP. NM; VCR; PCB; PRED. Trial Lead Organizations Southwest Oncology Group
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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