Steven DuBois, MD
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)
This phase 1, single treatment arm, prospective trial is designed to identify the maximally safe infusion duration of Naxitamab in combination with Irinotecan, Sargramostim, and Temozolomide for participants with relapsed, refractory, progressive neuroblastoma. Study doctors are studying different Naxitamab infusion duration levels (how quickly the drug is given into the vein) to determine if this makes a difference in side effects such as pain or infusion reactions. Not every participant in this research study will receive the same infusion duration of the study drug, Naxitamab. The infusion…
Inclusion Criteria: * Histologic Diagnosis: Patients must have had histologic verification of neuroblastoma or ganglioneuroblastoma or demonstration of neuroblastoma cells in the bone marrow with elevated urinary catecholamines \[i.e. \> 2 x upper limit of normal (ULN)\], at the time of initial diagnosis. * Relapsed or Refractory Disease Patients must have ONE of the following: * 1\) Any prior episode of recurrent high-risk disease following completion of frontline high-risk therapy. Patients may have received other lines of therapy for treatment of recurrent disease prior to enrolling to…
Recombinant humanized anti-GD2 monoclonal antibody, single-use vial, via intravenous (into the vein) infusion per protocol.
Topoisomerase Inhibitor, single-dose vial, via intravenous infusion per standard of care
Alkylating agent, capsule, via orally (by mouth) per standard of care
Recombinant human granulocyte-macrophage colony stimulating factor (rhu GM-CSF), multi-use vial, via subcutaneously (under the skin) injection per standard of care
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