A Phase 3 Study of 131I-Metaiodobenzylguanidine (131I-MIBG) or Crizotinib Added to Intensive Therapy for Children With Newly Diagnosed High-Risk Neuroblastoma (NBL)

Recruiting
1 years - 30 years
All
Phase N/A
1 Location

Brief description of study

The purpose of this study is to look at iobenguane I-131 or crizotinib and standard therapy in treating younger patients with newly-diagnosed high-risk neuroblastoma or ganglioneuroblastoma.

Detailed description of study

The purpose of this study is to determine in the context of a randomized trial whether the event-free survival (EFS) of patients with newly diagnosed high-risk neuroblastoma (NBL) is improved with the addition of iobenguane I-131 (131I-MIBG) during Induction, prior to tandem autologous stem cell transplantation (ASCT); and to determine whether the addition of crizotinib to standard 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.
Participants will not be paid for their participation.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: ganglioneuroblastoma,neuroblastoma
  • Age: 1 years - 30 years
  • Gender: All

Inclusion Criteria
Patients must be enrolled on ANBL00B1 or APEC14B1 prior to enrollment on ANBL1531
Patients must have a diagnosis of neuroblastoma or ganglioneuroblastoma (nodular) verified by tumor pathology analysis or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites
No known contraindication to peripheral blood stem cell (PBSC) collection
Exclusion Criteria
Patients with INRG stage L2 tumors without amplification of MYCN regardless of tumor histology (may meet criteria for may meet criteria for high risk classification but are not eligible for this trial)
Patients with bone marrow failure syndromes
Patients for whom targeted radiopharmaceutical therapy would be contraindicated due to underlying medical disorders
Female patients who are pregnant; a pregnancy test is required for female patients of childbearing potential - Lactating females who plan to breastfeed their infants
Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation

Updated on 04 Aug 2024. Study ID: PHO-COG-ANBL1531

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