Expanded Access Protocol Using 131I-MIBG
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|ClinicalTrials.gov Identifier: NCT01590680|
Expanded Access Status : Available
First Posted : May 3, 2012
Last Update Posted : August 13, 2019
|Condition or disease||Intervention/treatment|
|Neuroblastoma Pheochromocytoma Paraganglioma||Radiation: I-131 MIBG|
- To provide 131I-MIBG for compassionate use in patients with neuroblastoma, who otherwise do not qualify for inclusion or cannot participate in the sponsor's pivotal Phase II, FDA-approved, clinical trial.
- To provide 131I-MIBG for compassionate use in patients with neuroblastoma in the absence of a commercially available FDA approved product for the indication.
- Provide palliative therapy with 131I-MIBG for patients with advanced neuroblastoma.
- To provide alternative therapeutic 131I-MIBG options for patients with pheochromocytoma / paraganglioma, not qualifying for FDA-approved MIBG treatment.
- To provide alternative therapeutic 131I-MIBG options for patients with pheochromocytoma / paraganglioma, in the absence of a commercially available FDA-approved product for that indication.
- Gain more information about acute and late toxicity of 131I-MIBG therapy for patients with refractory neuroblastoma, pheochromocytoma, or paraganglioma.
Patients will receive a therapeutic dose at the investigator's discretion (5-18 mCi/kg). However, a dose of 12 mCi/kg or higher requires stored stem cells. Patients may be eligible for additional 131I-MIBG treatments (up to a cumulative total of 3 treatments) if they meet certain criteria.
Treatments with 131I-MIBG must be separated by a minimum of six weeks from previous 131I-MIBG therapy. Post-treatment evaluation will be performed 5-9 weeks (35-63 days) post treatment, and patients will be followed every 6 months until 2 years from therapy. All patients will have toxicity monitoring for 2 years following 131I-MIBG therapy, or until going off study.
|Study Type :||Expanded Access|
|See clinical trials of the intervention/treatment in this expanded access record.|
|Official Title:||An Open Label, Expanded Access Protocol Using 131I-metaiodobenzylguanidine (131I-MIBG) Therapy in Patients With Refractory Neuroblastoma, Pheochromocytoma, or Paraganglioma (Not Eligible for Approved Treatment)|
- 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): NCT01590680
|Contact: Norman LaFrance, MD,FACP||215-550-2765||Nlafrance@jdi.jubl.com|
|Contact: Alexandre Brkovic, PhD||514-694-8220 ext email@example.com|