Expanded Access Protocol Using 131I-MIBG
- Conditions
- NeuroblastomaParagangliomaPheochromocytoma
- Registration Number
- NCT01590680
- Lead Sponsor
- Jubilant DraxImage Inc.
- 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.
Recruitment & Eligibility
- Status
- AVAILABLE
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (19)
Children's Hospital Colorado
🇺🇸Aurora, Colorado, United States
Children's Healthcare of Atlanta
🇺🇸Atlanta, Georgia, United States
Seattle Children's Hospital
🇺🇸Seattle, Washington, United States
The Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
UPMC Children's Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Children's Medical Center Dallas
🇺🇸Dallas, Texas, United States
Children's Hospital Los Angeles
🇺🇸Los Angeles, California, United States
Carolinas Medical Center/ Levine Children's Hospital
🇺🇸Charlotte, North Carolina, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Monroe Carell Jr. Children's Hospital at Vanderbilt
🇺🇸Nashville, Tennessee, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
North Carolina Children's Hospital
🇺🇸Chapel Hill, North Carolina, United States
Cook Children's Medical Center
🇺🇸Fort Worth, Texas, United States
University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
Cincinnati Children's Hospital
🇺🇸Cincinnati, Ohio, United States
Michigan Medicine, University of Michigan
🇺🇸Ann Arbor, Michigan, United States
University of Wisconsin Hospital and Clinics, American Family Children's Hospital
🇺🇸Madison, Wisconsin, United States
Baylor College of Medicine, Texas Children's Hospital
🇺🇸Houston, Texas, United States