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

PHASE1RecruitingINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

June 27, 2025

Primary Completion Date

December 1, 2026

Study Completion Date

December 1, 2027

Conditions
NeuroblastomaNeuroblastoma RecurrentRelapsed NeuroblastomaRefractory Neuroblastoma
Interventions
DRUG

Naxitamab

Recombinant humanized anti-GD2 monoclonal antibody, single-use vial, via intravenous (into the vein) infusion per protocol.

DRUG

Irinotecan

Topoisomerase Inhibitor, single-dose vial, via intravenous infusion per standard of care

DRUG

Temozolomide

Alkylating agent, capsule, via orally (by mouth) per standard of care

DRUG

Sargramostim granulocyte-macrophage colony stimulating factor

Recombinant human granulocyte-macrophage colony stimulating factor (rhu GM-CSF), multi-use vial, via subcutaneously (under the skin) injection per standard of care

Trial Locations (2)

02115

RECRUITING

Boston Children's Hospital, Boston

RECRUITING

Dana-Farber Cancer Institute, Boston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Y-mAbs Therapeutics

INDUSTRY

lead

Steven DuBois, MD

OTHER