Dinutuximab-beta and Chemotherapy in Newly Diagnosed High-Risk Neuroblastoma

StatusRecruiting
PhasePhase 1
Started

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Record History

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  1. Recruitment opened
    • Eligibility criteria expanded, about 15 words
    • Secondary endpoints: details revised at 1 of 2 entries
    • Site details revised at 2 of 2 sites
  2. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
This clinical trial investigates the safety, side effects, and effectiveness of combining an immunotherapy drug called dinutuximab-beta with standard induction chemotherapy for patients newly diagnosed with high-risk neuroblastoma. Dinutuximab-beta is an antibody designed to target specific molecules on the surface of neuroblastoma cells. In this pilot study, enrolled patients will receive dinutuximab-beta as a continuous intravenous infusion alongside a standard 6-cycle induction chemotherapy regimen. The primary goals of this study are to monitor how well patients tolerate the new combination treatment closely and to determine how effectively tumors shrink before patients proceed to the next phase of their standard consolidation therapy.
Trial Details
NCT Number NCT07688252
Lead Sponsor Chang Gung Memorial Hospital
Collaborators: National Taiwan University Hospital
Conditions
(from sponsor)		 High Risk Neuroblastoma
Related terms Neuroblastoma
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov