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MT2018-19: COG ANBL1531 - 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) (IND# 134379)
Status: Recruiting
This partially randomized phase III trial studies iobenguane I-131 or ALK Inhibitor Therapy and standard therapy in treating younger patients (365 days to 30 years of age) with newly-diagnosed high-risk neuroblastoma or ganglioneuroblastoma.
Sex: Male or Female
Age Group: Not specified
Inclusion Criteria:
• Age: Patient must be ≥ 365 days and ≤ 30 years of age at diagnosis
• Diagnosis: 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: INRG Stage M & MYCN amplification or age > 547 days OR INRG Stage MS disease with MYCN amplification OR INRG Stage L2 disease with MYCN amplification
Exclusion Criteria:
• Patients who have an INRG Stage L2 tumor without amplification of MYCN
• Patients with bone marrow failure syndromes
• Pregnancy and Breastfeeding
Conditions:
Cancer
Keywords:
high risk, metastatic, neuroblastoma
Study Contact: Allison Fullenkamp - fulle631@umn.edu
Principal Investigator: Robin Williams
Phase: PHASE3
IRB Number: SITE00000265
See this study on ClinicalTrials.gov