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Naxitamab and GM-CSF in People With Neuroblastoma

Primary Purpose

High-Risk Neuroblastoma

Status
No longer available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
Naxitamab/GM-CSF
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for High-Risk Neuroblastoma focused on measuring Remission High-Risk Neuroblastoma, Relapsed/Refractory High-Risk Neuroblastoma, Naxitamab, GM-CSF, 20-227

Eligibility Criteria

18 Months - undefined (Child, Adult, Older Adult)All Sexes

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

Sites / Locations

  • Memorial Sloan Kettering Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 30, 2020
Last Updated
December 6, 2022
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT04501757
Brief Title
Naxitamab and GM-CSF in People With Neuroblastoma
Official Title
Expanded Access Use of Naxitamab/GM-CSF Immunotherapy for Consolidation of Complete Remission or Relapsed/Refractory High-Risk Neuroblastoma
Study Type
Expanded Access

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
No longer available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High-Risk Neuroblastoma
Keywords
Remission High-Risk Neuroblastoma, Relapsed/Refractory High-Risk Neuroblastoma, Naxitamab, GM-CSF, 20-227

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
Naxitamab/GM-CSF
Intervention Description
naxitamab/GM-CSF for 5 Cycles

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Months
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Kushner, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mskcc.org/mskcc/html/44.cfm
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

Naxitamab and GM-CSF in People With Neuroblastoma

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