Expanded Access Protocol Using I131-MIBG
Recruitment status was Available
- 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.
|Study Type:||Expanded Access What is Expanded Access?|
|Official Title:||An Open Label, Expanded Access Protocol Using 131I-metaiodobenzylguanidine (131I-MIBG)Therapy in Patients With Refractory Neuroblastoma, Pheochromocytoma, or Paraganglioma|
Radiation: I-131 MIBG
- I-131 Iobenguane
- I-131 meta-iodobenzylguanidine
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01590680
|Contact: Brian Weiss, M.D.||firstname.lastname@example.org|
|Principal Investigator:||Weiss Brian, M.D.||Cincinnati Children's Hospital (email@example.com)|
|Principal Investigator:||Suzanne Shusterman, M.D.||Dana-Farber Cancer Center Boston Children's Hospital|
|Principal Investigator:||Greg Yanik, M.D.||C.D. Mott's Children's Hospital University of Michigan, Ann Arbor (firstname.lastname@example.org)|
|Principal Investigator:||Haydar Frangoul, M.D.||Monroe Caroll Children's Hospital at Vanderbilt|
|Principal Investigator:||Michael Armstrong, M.D., Ph.D.||Duke University|
|Principal Investigator:||Julie Park, M.D.||Seattle Children's Hospital|
|Principal Investigator:||Meaghan Granger, M.D.||Cook Children's Health Care System|
|Principal Investigator:||Araz Marachelian, M.D.||Children's Hospital Los Angeles|