A Phase 2 interventional study of filgrastim and iobenguane I 131 in Neuroblastoma, sponsored by University of California, San Francisco. Completed at 3 sites in United States. Open to participants aged 1 Year and older. Per ClinicalTrials.gov, last updated 2014-08-18.
Sponsored by University of California, San Francisco · Phase 2, Interventional, and Treatment
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.
OBJECTIVES:
Primary
Secondary
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.
625 studies on the registry are indexed under Neuroblastoma; 122 are open to participants now.
This study's enrollment of 164 is above the median of 32 across 475 interventional studies indexed under Neuroblastoma.
Browse Neuroblastoma studies →University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.
Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Original diagnosis of neuroblastoma based on 1 of the following criteria:
Refractory or relapsed disease, meeting 1 of the following criteria:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
At least 3 months since prior radiotherapy to any of the following fields:
Ability of iodine I 131 metaiodobenzylguanidine to provide palliative therapy
Acute and late toxicities
Disease and symptom responses
This study is completed, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.
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University of California, San Francisco