Feasibility Study of Prolonged Administration of Naxitamab, Irinotecan, and Temozolomide for Patients With Relapsed or Refractory Neuroblastoma

This research is being done to investigate a treatment regimen of Irinotecan, Temozolomide, and Sargramostin, and an immunotherapy called Naxitamab and whether giving Naxitamab more slowly reduces the side effects for participants with relapsed or refractory neuroblastoma. The name of the study drugs involved in this study are: * Naxitamab (A type of monoclonal antibody) * Irinotecan (A standard of care chemotherapy) * Temozolomide (A standard of care chemotherapy) * Sargramostim (A standard of care, granulocyte-macrophage colony stimulating factor)

NCT Number	NCT07027748
Lead Sponsor	Steven DuBois, MD Collaborators: Y-mAbs Therapeutics
Conditions	Neuroblastoma, Neuroblastoma Recurrent, Relapsed Neuroblastoma, Refractory Neuroblastoma
Enrollment	18 participants
Start Date	2025-06-27
Primary Completion	2027-07-01 (estimated)
Study Completion	2027-12-01 (estimated)
Updated on ClinicalTrials.gov	2026-07-14