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Phase III Randomized Comparison of Alternating Courses of MOPP (NM/VCR/PRED/PCB) and ABVD (ADR/BLEO/VBL/DTIC) vs ABVD plus Low-Dose Regional Radiotherapy in Children with Advanced Hodgkin's Disease (Summary Last Modified 02/89)
Basic Trial Information
Objectives I. Compare relapse-free survival and survival in children with advanced Hodgkin's disease treated with alternating courses of MOPP (nitrogen mustard/vincristine/prednisone/procarbazine) and ABVD (adriamycin/bleomycin/vinblastine/DTIC) for a total of 12 courses of chemotherapy vs. 6 courses of ABVD followed by low-dose (2,100 cGy) regional radiotherapy. II. Compare the immediate and long-term toxicity associated with each of these treatment regimens. III. Compare the CR rates in the 2 treatment groups after 6 courses of chemotherapy. IV. Assess whether the 8-drug regimen obviates the need for radiotherapy by analyzing the patterns of relapse. V. Evaluate patterns and extent of disease at diagnosis and histologic subtypes with regard to prognostic significance, specifically pathologic subtypes III-1 vs. III-2 and micro vs. macro splenic involvement (more than 4 vs. 4 or fewer nodules). Entry Criteria Disease Characteristics: See General Eligibility Criteria Patient Characteristics: See General Eligibility Criteria General Eligibility Criteria: Patients less than 21 years of age at diagnosis with pathologically proven Hodgkin's disease of one of the following pathologic stages: III-1AS-macro, III-2A, IIIB, IVA, or IVB. Patients with pathologic Stage III-1A disease with a mediastinal mass greater than one-third the diameter of the thorax are also eligible. The pathologic diagnosis must have been established by nodal sampling above and below the diaphragm or by positive biopsies of liver, bone, bone marrow, or noncontiguous lung lesions. Chest x-ray, thoracic CT, and bone marrow aspiration and biopsy must have been performed prior to entry to determine eligibility. Patients with direct contiguous extension of disease from nodal to extra-nodal sites, without pathologic proof of Stage III or IV disease as defined above, are ineligible. Expected Enrollment 200 patients will be entered over about 4 years. Outline Randomized study. Arm I: 4-Drug Combination Chemotherapy Alternating with 4-Drug Combination Chemotherapy. MOPP: Nitrogen Mustard, NM, NSC-762; Vincristine, VCR, NSC-67574; Procarbazine, PCB, NSC-77213; Prednisone, PRED, NSC-10023; alternating with ABVD: Adriamycin, ADR, NSC-123127; Bleomycin, BLEO, NSC-125066; Vinblastine, VBL, NSC-49842; DTIC, NSC-45388. Arm II: 4-Drug Combination Chemotherapy Followed by Radiotherapy. ABVD; followed by regional radiotherapy using Co60 equipment, 4-10 MeV linear accelerators, or Betatron (electrons may be used only for boosts).Published Results Hutchinson RJ, Fryer CJ, Davis PC, et al.: MOPP or radiation in addition to ABVD in the treatment of pathologically staged advanced Hodgkin's disease in children: results of the Children's Cancer Group Phase III Trial. J Clin Oncol 16 (3): 897-906, 1998.[PUBMED Abstract] Maity A, Goldwein JW, Lange B, et al.: Comparison of high-dose and low-dose radiation with and without chemotherapy for children with Hodgkin's disease: an analysis of the experience at the Children's Hospital of Philadelphia and the Hospital of the University of Pennsylvania. J Clin Oncol 10 (6): 929-35, 1992.[PUBMED Abstract] Trial Lead Organizations Children's Cancer 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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