131I-Labeled MIBG for Refractory Neuroblastoma: A Compassionate Use Protocol

Inclusion Criteria: * Diagnosis: Refractory or relapsed neuroblastoma with original diagnosis based on tumor histopathology or elevated urine catecholamines with typical tumor cells in the bone marrow. Refractory, progressive or metastatic pheochromocytoma/paraganglioma or related tumor. * MIBG uptake: Tumors must be shown to be MIBG avid within 6 weeks prior to enrollment * Age \> 1 year and able to cooperate with radiation safety restrictions during therapy period. Patients with pheochromocytoma/paraganglioma and related tumors must be between 1 and 12 years of age. * Life Expectancy: greater than 6 weeks. * Lansky and Karnofsky Performance Status: 60% or higher. * Disease status: Failure to respond to standard therapy (usually combination chemotherapy with or without radiation and surgery) or development of progressive disease at any time (any new lesion or an increase in size of \>25% of a pre-existing lesion). Disease evaluable by MIBG scan must be present within 6 weeks of study entry and subsequent to any intervening therapy. * Stem cells: Patients must have an autologous hematopoietic stem cell product available for re-infusion after MIBG treatment at doses of \>12 mCi/kg if needed. The minimum quantity for purged or unpurged peripheral blood stem cells is 1.0 x 10\^6 cluster of differentiation 34 (CD34)+ cells/kg (optimum \> 2 x 10\^6 CD34+ cells/kg). The minimum dose for bone marrow is 1.0 x 10\^8 mononuclear cells/kg (optimum \> 2.0 x 10\^8 mononuclear cells/kg). …