RATIONALE: Giving iodine I 131 metaiodobenzylguanidine (\^131I-MIBG) may kill neuroblastoma cells by delivering radiation directly to the tumor. A stem cell transplant using the patient's stem cells may be able to replace blood-forming cells destroyed by radiation therapy. PURPOSE: This phase I trial is studying the side effects and best dose of a double infusion of \^131I-MIBG followed by autologous stem cell transplantation in treating patients with refractory neuroblastoma.
OBJECTIVES: Primary * Determine the maximum tolerated red marrow radiation dose delivered and associated toxic effects of escalating activity of iodine I 131 metaiodobenzylguanidine (\^131I-MIBG) followed by autologous hematopoietic stem cell transplantation in patients with refractory neuroblastoma. * Determine the number of days after stem cell transplantation to achieve absolute neutrophil count ≥ 500/mm\^3 for 3 days and platelet count ≥ 20,000/mm\^3 for 3 days (without transfusions) in patients treated with this regimen. Secondary * Determine the response rate in patients treated with this regimen, based on lesions measurable by CT or MRI at study entry, patients with \^131I-MIBG scan-positive lesions only, and patients with minimal residual tumor in bone marrow who have complete response by immunocytology and morphology. * Determine the tumor absorbed radiation dose in patients with measurable soft tissue lesions treated with this regimen. * Correlate, if possible, TP53 mutations with response in patients with accessible bone marrow tumor treated with \^131I-MIBG. OUTLINE: This is a dose-escalation, multicenter study. * Iodine I 131 metaiodobenzylguanidine (131I-MIBG) therapy: Patients receive\^131I-MIBG IV over 2 hours on days 0 and 14. Cohorts of 3-6 patients receive escalating doses of \^131I-MIBG until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. * Stem cell transplantation therapy: Patients undergo autologous peripheral blood stem cell transplantation on day 28. Patients receive filgrastim (G-CSF) IV over 1 hour OR subcutaneously daily beginning on day 28 and continuing until blood counts recover. Patients are followed every 3 months for 1 year and then annually thereafter. PROJECTED ACCRUAL: A total of 9-18 patients will be accrued for this study within 2 years.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Enrollment
18
Children's Hospital Los Angeles
Los Angeles, California, United States
UCSF Comprehensive Cancer Center
San Francisco, California, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
Children's Hospital Boston
Boston, Massachusetts, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States
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