Summary
Primary Objectives:
Provide palliative therapy with 131I-MIBG for patients with advanced neuroblastoma,
pheochromocytoma, or paraganglioma.
Gain more information about acute and late toxicity of 131I-MIBG therapy for patients
with refractory neuroblastoma, pheochromocytoma, or paraganglioma.
Objectives
Neuroblastoma, pheochromocytoma, and paraganglioma remain fatal diseases for a large
percentage of patients, especially those with high-risk disease features who become
resistant to conventional therapy. 131I-metaiodobenzylguanidine (131I-MIBG) is a
norepinephrine analog that concentrates in adrenergic tissue and has been shown to be
sensitive and specific for detecting localized and metastatic neuroblastoma,
pheochromocytoma, and paraganglioma. More importantly, experience of many institutions has
proven that this agent used as a targeted radiotherapeutic has significant anti-tumor
activity against refractory neuroblastoma 1-7 as well as pheochromocytoma and paraganglioma.
Children's Hospital of Philadelphia, UCSF, and the University of Michigan have just
completed a large Phase 2 study of 131I-MIBG given in doses of 10-18 mCi/kg with stem cell
rescue, if necessary, and have shown that this agent is safe and effective palliative
therapy for refractory or relapsed neuroblastoma patients. In addition, there is growing
evidence that low-dose (5-10 mCi/kg) submyeloablative MIBG therapy is both safe and
effective for disease palliation. This protocol therefore provides a mechanism to deliver
this therapy when clinically indicated.