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
|First Submitted Date||May 1, 2012|
|First Posted Date||May 3, 2012|
|Last Update Posted Date||August 13, 2019|
|Brief Title||Expanded Access Protocol Using 131I-MIBG|
|Brief Summary||Protocol JDI2007-01 is an Expanded Access Protocol with therapeutic 131I-MIBG for patients with neuroblastoma or pheochromocytoma / paraganglioma, who otherwise do not qualify for available treatments, or where approved treatment is not commercially available.|
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|
|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||United States|
|Removed Location Countries|
|Responsible Party||Jubilant DraxImage Inc.|
|Study Sponsor||Jubilant DraxImage Inc.|
|PRS Account||Jubilant DraxImage Inc.|
|Verification Date||August 2019|