Expanded Access Protocol Using I131-MIBG
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|ClinicalTrials.gov Identifier: NCT01590680|
Recruitment Status : Available
First Posted : May 3, 2012
Last Update Posted : September 27, 2016
Jubilant DraxImage Inc.
Information provided by (Responsible Party):
Jubilant DraxImage Inc.
|First Submitted Date||May 1, 2012|
|First Posted Date||May 3, 2012|
|Last Update Posted Date||September 27, 2016|
|Brief Title||Expanded Access Protocol Using I131-MIBG|
|Detailed Description||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.|
|Study Type||Expanded Access|
|Intervention||Radiation: I-131 MIBG
The therapeutic dose (5-18 mCi/kg at investigator's discretion; any dose ≥12 mCi/kg requires stored stem cells) will be diluted in normal saline, and will be infused intravenously over 90-120 minutes.
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Expanded Access Status||Available|
|Listed Location Countries||Not Provided|
|Removed Location Countries|
|Responsible Party||Jubilant DraxImage Inc.|
|Study Sponsor||Jubilant DraxImage Inc.|
|PRS Account||Jubilant DraxImage Inc.|
|Verification Date||September 2016|