About this trial
The purpose of this research study is to find how active and safe 131 I-MIBG is in patients with resistant neuroblastoma, malignant pheochromocytoma and malignant paraganglioma.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- iobenguane I 131
Treatment groups
Sponsors and collaborators
Memorial Sloan Kettering Cancer Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator