Status:
NO_LONGER_AVAILABLE
Naxitamab and GM-CSF in People With Neuroblastoma
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
High-Risk Neuroblastoma
Eligibility:
All Genders
18+ years
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 st...
Eligibility Criteria
Inclusion
- 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
- Active life-threatening infection
- Pregnant women or women who are breastfeeding
- HAHA titer positive
- History of anaphylaxis CTCAE grade 4 to naxitamab
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04501757
Last Update
December 8 2022
Active Locations (1)
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1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065