A Phase 3 Study of 131I-Metaiodobenzylguanidine (131I-MIBG) or Crizotinib Added to Intensive Therapy for Children with Newly Diagnosed High-Risk Neuroblastoma (NBL) (IND# 134379)
Categories (click each to see list of all clinical trials associated with that category): CTO Pediatric Trials (ONC), Pediatric (PEDONC)
Current Status: Open
Phase: III (Cancer Control)
Principal Investigator: Beck, Jill
Eligibility: https://clinicaltrials.gov/study/NCT03126916?term=NCT03126916&rank=1
Summary
To determine in the context of a randomized trial whether the EFS of patients with newly diagnosed high-risk NBL is improved with the addition of 131I-MIBG during Induction, prior to tandem autologous stem cell transplantation (ASCT).
To determine whether the addition of crizotinib to intensive multimodality therapy for patients with high-risk NBL whose tumors harbor activating point mutations in or amplification of the ALK gene results in superior EFS compared to a contemporaneously treated cohort of patients whose tumors lack these ALK aberrations.
To describe the toxicities associated with treatment for high-risk NBL with and without the addition of 131I-MIBG or crizotinib.
To estimate EFS and describe toxicity in patients with newly diagnosed high risk NBL randomized to treatment with an 131I-MIBG-containing Induction prior to BuMel ASCT.
To describe the OS and response rates (evaluated per INRC criteria prior to ASCT and prior to post-Consolidation therapy) for patients with high-risk neuroblastoma treated with or without 131I-MIBG or crizotinib.
To prospectively evaluate the relationship of response rate per revised International Neuroblastoma Response Criteria (INRC) to EFS and OS in patients with high-risk NBL treated with and without the addition of 131I-MIBG or crizotinib.