At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of neuroblastoma or ganglioneuroblastoma (nodular) verified by tumor pathology or bone marrow with elevated urinary catecholamine metabolites
- ✓INRG stage M with MYCN amplification (>4-fold) or age >547 days
- ✓INRG stage MS with MYCN amplification
- ✓INRG stage L2 with MYCN amplification
- ✕INRG stage L2 without MYCN amplification
- ✕Bone marrow failure syndromes
- ✕Contraindication to targeted radiopharmaceutical therapy
- ✕Pregnant females
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 3 clinical trial evaluating Autologous Hematopoietic Stem Cell Transplantation, Biospecimen Collection, and 25 other interventions for Ganglioneuroblastoma and 2 related conditions. Currently recruiting, targeting 750 participants across 162 sites in 3 countries.
Signals
Detailed 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.
Study Details
Timeline
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