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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
Sponsor:
Information provided by (Responsible Party):
Jubilant DraxImage Inc.

Tracking Information
First Submitted Date May 1, 2012
First Posted Date May 3, 2012
Last Update Posted Date August 13, 2019
 
Descriptive Information
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.
Detailed Description

Primary Objectives:

  • 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
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.
Other Names:
  • I-131 Iobenguane
  • I-131 meta-iodobenzylguanidine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Expanded Access Status Available
Contacts
Contact: Norman LaFrance, MD,FACP 215-550-2765 Nlafrance@jdi.jubl.com
Contact: Alexandre Brkovic, PhD 514-694-8220 ext 2464 alexandre.brkovic@jdi.jubl.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01590680
Responsible Party Jubilant DraxImage Inc.
Study Sponsor Jubilant DraxImage Inc.
Collaborators Not Provided
Investigators Not Provided
PRS Account Jubilant DraxImage Inc.
Verification Date August 2019