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ANBL1531

Title A Phase 3 Study of 131I-Metaiodobenzylguanidine (131I-MIBG) or Crizotinib Added to Intensive Therapy for Children With Newly Diagnosed High-Risk Neuroblastoma (NBL)
Therapeutic Area Neuroblastoma
Principal Investigator Michael J Kelly, MD
Min Age 1 Years
Max Age 30 Years
Gender All
Contact Jordan Pothier
617-636-8885
Jpothier@tuftsmedicalcenter.org
More Information https://www.clinicaltrials.gov/ct2/show/NCT03126916

Overview

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.

Study Details

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; the following disease groups are eligible:
  • Patients with International Neuroblastoma Risk Group (INRG) stage M disease are eligible if found to have either of the following features:
    • MYCN amplification (> 4-fold increase in MYCN signals as compared to reference signals), regardless of age or additional biologic features; OR
    • Age > 547 days regardless of biologic features
    • Patients with INRG stage MS disease with MYCN amplification

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

Study Requirements

Will be standard of care with the addition of two Investigational Agents. Optional research samples and procedures are explained in consent form.