RecruitingPhase 1NCT07027748

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


Sponsor

Steven DuBois, MD

Enrollment

18 participants

Start Date

Jun 27, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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)


Eligibility

Min Age: 1 YearMax Age: 30 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a prolonged course of a combination of drugs — naxitamab, irinotecan, and temozolomide — is safe and feasible for children and young adults with neuroblastoma (a childhood cancer) that has come back or stopped responding to treatment. **You may be eligible if:** - You have been diagnosed with high-risk neuroblastoma (confirmed by biopsy at original diagnosis) - Your cancer has relapsed (come back) after completing standard treatment, or it progressed during standard treatment - You are in adequate physical health to receive treatment - Certain lab values (blood, kidney, liver, heart function) are within acceptable ranges **You may NOT be eligible if:** - You have active, uncontrolled infection - You have significant organ damage (heart, kidney, liver) - You are pregnant or breastfeeding - You have a history of severe allergic reaction to any of the study drugs - You have progressing cancer that has spread to the brain Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNaxitamab

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

DRUGIrinotecan

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

DRUGTemozolomide

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

DRUGSargramostim 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


Locations(2)

Boston Children's Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

View Full Details on ClinicalTrials.gov

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NCT07027748


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