Clinical Trial: Expanded Access Protocol Using I131-MIBG
Study Status: Available
Recruit Status: Available
Study Type: Expanded Access
Official Title: An Open Label, Expanded Access Protocol Using 131I-metaiodobenzylguanidine (131I-MIBG)Therapy in Patients With Refractory Neuroblastoma, Pheochromocytoma, or Paraganglioma
Brief 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.
Detailed Summary: 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.
Sponsor: Jubilant DraxImage Inc.
Current Primary Outcome:
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Jubilant DraxImage Inc.
Dates:
Date Received: May 1, 2012
Date Started:
Date Completion:
Last Updated: September 23, 2016
Last Verified: September 2016
