FindTrial
Sign In

Naxitamab and GM-CSF in People With Neuroblastoma

Expanded Access Use of Naxitamab/GM-CSF Immunotherapy for Consolidation of Complete Remission or Relapsed/Refractory High-Risk Neuroblastoma

Status
NO_LONGER_AVAILABLE
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT04501757
Enrollment
Unknown
Registered
2020-08-06
Start date
Unknown
Completion date
Unknown
Last updated
2022-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High-Risk Neuroblastoma

Keywords

Remission High-Risk Neuroblastoma, Relapsed/Refractory High-Risk Neuroblastoma, Naxitamab, GM-CSF, 20-227

Brief 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.

Interventions

BIOLOGICALNaxitamab/GM-CSF

naxitamab/GM-CSF for 5 Cycles

Sponsors

Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER

Eligibility

Sex/Gender
ALL
Age
18 Months to No maximum

Inclusion criteria

* Patients who are ineligible to participate in study NCT03363373 (IRB# 18-375), will be considered for treatment under this expanded access protocol. * Diagnosis of NB as defined by a) histopathology (confirmed by the MSK Department of Pathology), or b) BM metastases or MIBG-avid lesion(s) plus high urine catecholamine levels * Patients must have HR-NB (MYCN-amplified stage 2/3/4/4S of any age and MYCNnonamplified stage 4 in patients greater than 18 months of age). * Patients must be in first or greater CR or have refractory or relapsed disease * If previously treated with any anti-GD2 mAb, human anti-hu3F8 antibody (HAHA) titer must be negative.

Exclusion criteria

* Active life-threatening infection * Pregnant women or women who are breastfeeding * HAHA titer positive * History of anaphylaxis CTCAE grade 4 to naxitamab

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026