131 I-MIBG in Treating Patients With Refractory or Relapsed Neuroblastoma
- Conditions
- Neuroblastoma
- Registration Number
- NCT00293319
- Lead Sponsor
- University of California, San Francisco
- Brief Summary
RATIONALE: Radioactive drugs, such as 131 I-MIBG, may carry radiation directly to tumor cells and not harm normal cells.
PURPOSE: This phase II trial is studying how well 131 I-MIBG works in treating patients with refractory or relapsed neuroblastoma.
- Detailed Description
OBJECTIVES:
Primary
* Determine if iodine I 131 metaiodobenzylguanidine can provide palliative therapy for patients with refractory or relapsed neuroblastoma.
* Determine the acute and late toxicity of this regimen in these patients.
Secondary
* Determine disease and symptom responses of patients treated with this regimen.
OUTLINE: This is a compassionate use study.
Patients receive iodine I 131 metaiodobenzylguanidine IV over 2 hours. Beginning 10 days later, patients with low neutrophil counts receive filgrastim (G-CSF) subcutaneously until blood count recovers. Patients with stable or responding disease may receive a second dose of iodine I 131 metaiodobenzylguanidine at least 6 weeks after the first dose.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 164
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Acute and late toxicities Ability of iodine I 131 metaiodobenzylguanidine to provide palliative therapy
- Secondary Outcome Measures
Name Time Method Disease and symptom responses
Trial Locations
- Locations (3)
UCSF Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States