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

Investigating Treatment Options for High-Risk Neuroblastoma in Young Patients

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 19 Feb 2024. Study ID: PHO-COG-ANBL1531

This study investigates the use of investigational medications along with standard therapy in treating young patients with high-risk neuroblastoma or ganglioneuroblastoma. Neuroblastoma is a type of cancer that occurs in certain types of nerve tissue and is most commonly found in children. The study aims to see if adding investigational medications can improve outcomes for these patients.

Participants in this study will receive either iobenguane I-131 or crizotinib in addition to standard cancer treatments. Iobenguane I-131 is a type of radiopharmaceutical therapy, while crizotinib targets specific genetic changes in the tumor. The study will compare how these treatments affect the progression of the disease and the overall survival of the patients.

  • Who can participate: Eligible participants are young patients diagnosed with neuroblastoma or ganglioneuroblastoma confirmed by pathology or specific tests. They must have no contraindications to certain medical procedures and agree to use effective contraception if of reproductive potential.
  • Study details: Participants will receive either iobenguane I-131 or crizotinib along with standard therapy. A placebo is not used in this study.

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