Giselle Sholler
A prospective, multicenter, clinical trial in participants with high-risk neuroblastoma that have completed induction therapy, evaluating the feasibility, efficacy, and toxicity of using anti-GD2 chemo-immunotherapy (naxitamab/irinotecan/temozolomide/GM-CSF) as consolidation followed by standard radiation, then standard anti-GD2 immunotherapy, and 2 years of DFMO maintenance.
Inclusion Criteria: * Age 1. Participants must be age ≤ 21 years at High-Risk NB diagnosis 2. Participants must be \>12 months of age at enrollment. Diagnosis 3. Participants must have a pathologically confirmed diagnosis of neuroblastoma and classified as high risk by the criteria used by COG or SIOPEN at the time of diagnosis. Exception: patients who are initially diagnosed as non high-risk neuroblastoma, but later converted to high-risk neuroblastoma are also eligible. Prior Therapy 4. Participants must have completed standard induction therapy for initial diagnosis of…
anti-GD2 chemo-immunotherapy (naxitamab/irinotecan/temozolomide/GM-CSF) as consolidation
Dinutuximab + GM-CSF + Isotretinoin (or Dinutuximab-Beta) for 5 cycles plus Isotretinoin alone in Cycle 6
DFMO Monotherapy: DFMO for 730 days (2 years)
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