Why are we doing this research?
This partially randomized phase III trial studies iobenguane I-131 or crizotinib and standard therapy in treating younger patients with newly-diagnosed high-risk neuroblastoma or ganglioneuroblastoma. Radioactive drugs, such as iobenguane I-131, may carry radiation directly to tumor cells and not harm normal cells. Crizotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving iobenguane I-131 or crizotinib and standard therapy may work better in treating younger patients with neuroblastoma or ganglioneuroblastoma.
PRIMARY OUTCOME MEASURES:
- Event free survival (EFS) rate [ Time Frame: From the time of randomization or assignment to first episode of disease relapse or progression, first occurrence of a second malignancy, or death, assessed for up to 5 years ]
- Will be assessed with an intent-to-treat log-rank test comparison of EFS rates. The EFS of patients assigned to the ALK-aberrant crizotinib treatment arm will be compared with an intent-to-treat log-rank test to that of all patients assigned to the ALK wild type portion of the trial, except for those patients randomized to receive iobenguane I-131 (131I-MIBG).
Study Type: Interventional
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment