A phase II study of 131I-MIBG for refractory neuroblastoma

8504 Purpose: To evaluate the effect of disease sites, prior therapy and dose on response rates and toxicity with 131I-MIBG treatment of children with refractory neuroblastoma. Methods: 151 patients with progressive, refractory or relapsed neuroblastoma, age 2–30 years with normal organ function, were treated in a limited institution Phase II study from 8/30/96 to 10/1/04. Patients with adequate hematopoietic stem cells (HSC) were treated with 18 mCi/kg of 131I-MIBG; those without HSC were treated at 12 mCi/kg. Patients were stratified according to whether or not they had received prior myeloablative therapy (HSCT) and whether or not they had soft tissue (ST) involvement or just bone and/or bone marrow disease (B/BM). Results: Hematologic toxicity was common, with 28% of patients receiving autologous HSC infusion for prolonged myelosuppression. Non-hematological toxicity was rare, with 6% of patients experiencing hepatic, 6% pulmonary, and 12% infectious grade 3–4 toxicity. The overall response rate (CR/V...