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Naxitamab and GM-CSF in People With Neuroblastoma

NCT04501757 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2022-12-08

No results posted yet for this study

Summary

This is an Expanded Access Program (EAP) that will give the participants access to the drug naxitamab before it is approved by the FDA. Naxitamab will be combined with granulocyte-macrophage colony stimulating factor (GM-CSF). Participants in this study will have high-risk neuroblastoma that either went away completely after treatment (complete remission) or has come back (relapsed/refractory).

Researchers think the combination of naxitamab and GM-CSF will be effective because naxitamab and GM-CSF strengthen the immune system's response to cancer cells in different ways. Naxitamab is an antibody, like the proteins made by the immune system to protect the body from harm. Naxitamab helps the cells of the immune system to find and attack cancer cells. GM-CSF is a protein that strengthens the immune system by increasing the number of immune cells called granulocytes. Granulocytes are white blood cells that fight off cancer cells. The combination of naxitamab and GM-CSF is a type of immunotherapy.

Conditions

  • High-Risk Neuroblastoma

Interventions

BIOLOGICAL

Naxitamab/GM-CSF

naxitamab/GM-CSF for 5 Cycles

Sponsors & Collaborators

Principal Investigators

  • Brian Kushner, MD · Memorial Sloan Kettering Cancer Center

Eligibility

Min Age
18 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04501757 on ClinicalTrials.gov