Clinical Trial Finder

Inclusion criteria for NB:

• - Patients must have the diagnosis of NB in accordance with the International Criteria, i.e., either histopathology (confirmed by the MSKCC Department of Pathology) or BM involvement plus elevated urinary catecholamines.

• - Must have a history of tumor progression or recurrence or failure to achieve complete response with standard therapy.

• - Patients must have MIBG-avid NB and evaluable disease on MIBG scan at time of enrollment on protocol.

• - Prior Therapy: At least 2 weeks should have elapsed since any biologic therapy.

Three weeks should have elapsed since last dose of chemotherapy.

• - Age >1 year with a determination that radiation safety restrictions during therapy period can be implemented.

• - Stem cells: Patients for high does must have an autologous hematopoietic stem cell product cryopreserved and available for re-infusion after MIBG treatment.

Patients for low dose do not require cryopreserved autologous hematopoietic stem cell product available. The minimum dose for peripheral blood stem cells is 2 X106 CD34+ cells/kg.

• - Minimum life expectancy of eight weeks.

• - Signed informed consent indicating awareness of the investigational nature of this program.

Inclusion criteria for malignant CCT:

• - Patients must have the diagnosis of malignant CCT i.e. malignant pheochromocytoma or malignant paraganglioma.

• - Patients must have MIBG-avid malignant CCT and evaluable disease on MIBG scan at time of enrollment on protocol.

• - Prior Therapy: At least 2 weeks should have elapsed since any biologic therapy.

Three weeks should have elapsed since last dose of chemotherapy.

• - Age between 1 and 21 years and able to cooperate with radiation safety restrictions during therapy period.

• - Stem cells: Patients must have an autologous hematopoietic stem cell product cryopreserved and available for re-infusion after MIBG treatment.

The minimum dose for peripheral blood stem cells is 2 X106 CD34+ cells/kg.

• - Minimum life expectancy of eight weeks.

• - Signed informed consent indicating awareness of the investigational nature of this program.

Exclusion Criteria:

• - Severe major organ toxicity.

Specifically, renal, cardiac, hepatic, pulmonary, gastrointestinal and neurologic toxicity should all be grade 2 or less. A grade 3 hearing deficit is acceptable.

• - Active serious infections not controlled by antibiotics.

• - Pregnant women are excluded for fear of danger to the fetus.

Therefore negative pregnancy test is required for all women of child-bearing age, and appropriate contraception is used during the study period.

• - Inability or unwillingness to comply with radiation safety procedures or protocol requirements.

Arms

Experimental: Radiation

Interventions

Drug: - iobenguane I 131

Patients receive a single dose of iodine I 131 metaiodobenzylguanidine (^131I-MIBG) IV over 30 minutes to 4 hours or for 15 minutes for smaller patients on day 0. Patients undergo radiation dosimetry following the first dose of ^131I-MIBG to determine if a second dose can be safely administered. Some patients may receive a second dose of iodine I 131 metaiodobenzylguanidine (^131I-MIBG) 6-8 weeks after the first dose if response is achieved and patients do not experience major toxicity. After blood radioactivity has fallen below 1 μCi/mL, patients may undergo autologous stem cell transplantation. After completion of study treatment, patients are followed at 4-6 weeks after ^131I-MIBG administration and then every 3 months for up to 1 year. Once patients are off treatment on this protocol, they will begin long term follow up through 5 years from enrollment.