Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL)
A Phase 3 Study of 131I-Metaiodobenzylguanidine (131I-MIBG) or ALK Inhibitor Therapy Added to Intensive Therapy for Children With Newly Diagnosed High-Risk Neuroblastoma (NBL)
Children's Oncology Group
750 participants
May 14, 2018
INTERVENTIONAL
Conditions
Summary
This phase III trial studies iobenguane I-131 or lorlatinib 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. Lorlatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving iobenguane I-131 or lorlatinib and standard therapy may work better compared to lorlatinib and standard therapy alone in treating younger patients with neuroblastoma or ganglioneuroblastoma.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Undergo autologous HSCT
Undergo blood sample collection
Undergo bone marrow aspiration and biopsy
Given IV
Given IV
Given IV
Undergo CT scan
Given IV
Given IV
Given IV
Given IV
Undergo echocardiography
Given IV
Undergo EBRT
Given 123 I-MIBG
Given IV
Given PO
Given PO
Undergo MRI
Given IV
Undergo MUGA scan
Undergo PET scan
Given SC
Undergo standard of care surgery
Given IV
Given IV
Given IV
Locations(162)
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For the most up-to-date information, visit the official listing.
NCT03126916