131-I-MIBG Therapy for Refractory Neuroblastoma and Metastatic Pheochromocytoma (CHP-830)

Inclusion Criteria:

• Refractory or relapsed neuroblastoma with original diagnosis based on tumor histopathology or elevated urine catecholamines with typical neuroblastoma cells in the bone marrow OR Metastatic Pheochromocytoma
• Age greater than 1 year and able to cooperate with radiation safety restrictions during therapy period.
• Performance Level: Patients must have a Karnofsky or Lansky performance status of equal to or greater than 50 percent
• Life expectancy: Patients must have a life expectancy of at least 8 weeks
• 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 8 weeks of study entry and subsequent to any intervening therapy. The principal or co-investigator can waive the requirement for intervening therapy if in their judgment this would pose undue risk and would not affect ability to judge treatment effectiveness.
• Stem cells: Patients must have a hematopoietic stem cell product available for re-infusion after MIBG treatment at doses of 12 mCi/kg. The minimum quantity for peripheral blood stem cells is 1.0 x 106 CD34+ cells/kg
• Prior Therapy: Patients may enter this study with or without re-induction therapy for recurrent tumor. Patients must have fully recovered from the toxic effects of any prior therapy. At least 2 weeks should have elapsed since any chemotherapy causing myelosuppression and at least one week since any biologic agent or low-dose chemotherapy agent that does not cause myelosuppression. The patient must meet hematologic criteria below. Three-months should have elapsed in the case of completing radiation to any of the following fields: craniospinal, total abdominal, whole lung, total body irradiation). Cytokine therapy (e.g. G-CSF, GM-CSF, IL-6, erythropoietin) must be discontinued a minimum or 24 hours prior to MIBG therapy.
• Liver function: Bilirubin ≤2x upper limit of normal; AST/ALT ≤10x upper limit of normal
• Kidney function: Creatinine ≤3x upper limit of normal
• Hematopoietic Criteria: ANC ≥750/L; Platelets ≥50,000/L without transfusion if stem cells are not available (any ANC or platelet allowed if stem cells available).
• Normal lung function as manifested by no dyspnea and/or no hypoxia greater than grade 3
• No clinically significant cardiac dysfunction
• Signed informed consent: The patient and/or the patient's legally authorized guardian must acknowledge in writing that consent to become a study subject has been obtained, in accordance with institutional policies approved by the U.S. Department of Health and Human Services.

Exclusion Criteria:

• Patients with disease of any major organ system that would compromise their ability to withstand therapy. Any significant organ impairment should be discussed with the Study Chair or Vice Chair prior to patient entry.
• Because of the teratogenic potential of the study medications, no patients who are pregnant or lactating will be allowed. Patients of childbearing potential must practice an effective method of birth control while participating on this study, to avoid possible damage to the fetus.
• Patients who are on hemodialysis
• Patients with uncontrolled infections that meet grade 3-4 toxicity criteria.