Naxitamab Added to Induction for Newly Diagnosed High-Risk Neuroblastoma
A Phase II study of Naxitamab added to induction Therapy for Subjects with Newly Diagnosed High Risk Neuroblastoma
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Clinical Trial Information
Trial Contact: Doyle, Katherine M; Armatti, Julie M; Parker, Melanie; Frankos, Marie
Trial Phone: 3218412008 ; 321-843-5284 ; 321-843-1036 ; 321-842-8738
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IRB No: 23.113.06
Protocol Abbrev: BCC018
Principal Investigator: Jaime A. Carvajal, MD
Phase: Drug: Phase II
Age Group: Pediatric
Secondary Protocol No: BCC018
Treatment: Drug: Naxitamab Drug: Ceritinib
Therapies Involved: Chemotherapy
ClinicalTrials.gov ID: NCT05489887
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Objective
This is a prospective, multicenter clinical trial in subjects with newly diagnosed high-risk neuroblastoma to evaluate the efficacy and safety of administering naxitamab with standard induction therapy. The initial chemotherapy will include 5 cycles of multi-agent chemotherapy. Naxitamab will be added to all 5 Induction cycles. Subjects with an ALK mutation or amplification will have ceritinib added to their treatment regimen as soon as results are available. We hypothesize that the addition of anti-GD2 therapy to induction chemotherapy will result in improved end of induction responses and improved survival.
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Key Eligibility
Diagnosis: Subjects must have a diagnosis of neuroblastoma or ganglioneuroblastoma (nodular or intermixed) verified by histology or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites; Subjects must be age ≤ 21 years at initial diagnosis; Subjects must be >12 months of age at enrollment
