Expanded Access Protocol Using 131I-MIBG Therapy for Refractory Neuroblastoma, Pheochromocytoma, or Paraganglioma
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|ClinicalTrials.gov Identifier: NCT01838187|
Expanded Access Status : Available
First Posted : April 23, 2013
Last Update Posted : December 21, 2017
Currently there is no known effective treatment for patients with advanced stage neuroblastoma, pheochromocytoma, or paraganglioma who have relapsed or not responded to standard therapy. In previous studies that used 131I-MIBG as a potential anti-cancer therapy, a decrease in the size of tumors was seen in some of the children and adults. This research study will continue to evaluate the side effects of 131I-MIBG when treating children and adults with neuroblastoma, pheochromocytoma, or paraganglioma. The 131I-MIBG compound is intended to work by selectively delivering the radioactive iodine to the tumor cells, which is then intended to result in their destruction.
The purpose of this research study is to:
- Make 131I-MIBG therapy available to patients with advanced neuroblastoma, pheochromocytoma, or paraganglioma
- Further assess the side effects of 131I-MIBG therapy
|Condition or disease||Intervention/treatment|
|Neuroblastoma Pheochromocytoma Paraganglioma||Radiation: I-131 MIBG|
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.
- 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|
|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
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.Other Names:
- ◦I-131 Iobenguane
- ◦I-131 meta-iodobenzylguanidine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01838187
|Contact: Laura Fossett||(513) email@example.com|
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229|
|Contact: Laura Fossett 513-636-2799 firstname.lastname@example.org|
|Principal Investigator:||Brian Weiss, MD||Children's Hospital Medical Center, Cincinnati|