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Surgical Resection, Chemotherapy with CTX/ADR, Radiotherapy and Immunotherapy with BCG and Tumor Cells for Neuroblastoma
Basic Trial Information
Objectives I. Evaluate a new schedule of drugs for the treatment of neuroblastoma. II. Evaluate in patients with bone marrow involvement the cell cycle kinetics of neuroblastoma cells. III. Evaluate cellular and humoral immune responses of patients with neuroblastoma to allogenic and autologous tumor cells. IV. Use adjuvant immunotherapy as additional therapy for patients with Stage III disease. Entry Criteria Disease Characteristics: See General Eligibility Criteria Patient Characteristics: See General Eligibility Criteria General Eligibility Criteria: Patients with neuroblastoma or ganglioneuroblastoma who have had no prior treatment with chemotherapy. Expected Enrollment 40 to 60 patients will be entered over 4 years. Protocol closed 05/76. Outline Randomized study - in part. Arm I: Surgery: Enter all patients: Stage I and IIA - complete resection; Stage IIB - subtotal resection; Stages IIIA, B and C -subtotal resection when possible, plus second-look surgery to remove residual primary following complete response to chemotherapy. Arm II: Radiotherapy: Enter all Stage II patients. Enter Stage III patients if immediate control of tumors is required. Chemotherapy: Stage IIB and all Stage III patients before or concurrent with Radiotherapy. Arm III: 2-Drug Combination Chemotherapy. Cyclophosphamide, CTX, NSC-26271; Adriamycin, ADR, NSC-123127. Randomize responders to Arm IV or Arm V. Arm IV: 2-Drug Combination Chemotherapy. CTX, ADR, continued for 8 months. Arm V: Immunotherapy. Autologous tumor cells and BCG-Glaxo. Trial Lead Organizations St. Jude Children's Research Hospital
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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