Expanded Access Protocol Using 131I-MIBG Therapy +/- Vorinostat for Refractory Neuroblastoma, Pheochromocytoma, or Paraganglioma
Part of paid clinical trials in Cincinnati, Ohio.
- Sponsor
- Children's Hospital Medical Center, Cincinnati
- Study ID
- NCT01838187
- Status
- No Longer Available
Conditions
- Neuroblastoma
- Paraganglioma
- Pheochromocytoma
Eligibility Criteria
- Sex
- ALL
- Age
- 12 Months - N/A
- Healthy Volunteers
- Not accepted
Interventions
- I-131 MIBG — RADIATIONThe 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.
- Vorinostat — DRUG180 mg/m2 orally once daily on days 0 to +13
Study Details
Currently there is no known effective treatment for patients with advanced stage neuroblastoma who have relapsed or not responded to standard therapy. There is also no known effective treatment for patients with pheochromocytoma or paraganglioma who are less than 12 years of age. 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 +/- Vorinostat 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
Key Dates
- Status verified
- Aug 2023
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | - |
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