Iodine I 131 Metaiodobenzylguanidine in Treating Patients With Recurrent, Progressive, or Refractory Neuroblastoma or Malignant Pheochromocytoma or Paraganglioma

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age1+
SponsorMemorial Sloan Kettering Cancer Center

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

200 Participants
are divided into 1 treatment group

Locations

1
Memorial Sloan Kettering Cancer Center10065, New YorkNew York, United States

Sponsors and collaborators

Memorial Sloan Kettering Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator