Spots Global Cancer Trial Database for 131 I-MIBG in Treating Patients With Refractory or Relapsed Neuroblastoma

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Trial Identification

Brief Title: 131 I-MIBG in Treating Patients With Refractory or Relapsed Neuroblastoma

Official Title: I-Metaiodobenzylguanidine (I-MIBG) Therapy for Refractory Neuroblastoma, A Phase II Study

Study ID: NCT00293319

Conditions

Neuroblastoma

Interventions

filgrastim

iobenguane I 131

Study Description

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.