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ANBL1531: Newly Diagnosed High-Risk Neuroblastoma - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out if we can improve the treatment for patients with high-risk neuroblastoma by adding the study drug 131I-MIBG (131I-metaiodobenzylguanidine) or the study drug crizotinib to the standard treatment.

What is the Condition Being Studied?

Newly Diagnosed High-Risk Neuroblastoma

Who Can Participate in the Study?

Children and Adults with Neuroblastoma who:
- Are 1 year old and less than 30 years old
- Are able to tolerate peripheral blood stem cell collection

Age Group
Adults, Children

What is Involved?

If you choose to be in this study, you will:
- Be randomized (like drawing numbers out of a hat) to get either:
-- Group 1: Standard of care treatment
-- Group 2: Study drug 131I-MIBG and standard of care treatment
-- Group 3: Study drug 131I-MIBG and one stem cell transplant and standard of care chemotherapy
-- Group 4: Standard of care treatment
-- Group 5: Study drug Crizotinib plus standard of care treatment
- Have a scan and have tissue taken from your tumor sent for a test to see if it contains a specific gene
- Have standard treatment called induction therapy

Study Details

Full Title
ANBL1531: A Phase 3 Study of 131 I-Metaiodobenzylguanidine (131 I-MIBG) or Crizotinib Added to Intensive Therapy for Children with Newly Diagnosed High-Risk Neuroblastoma (NBL)
Principal Investigator
Pediatric Hematology-Oncology Specialist
Protocol Number
IRB:PRO00100226
NCT:NCT03126916
Phase
Phase III
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698