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Naxitamab and GM-CSF in People With Neuroblastoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04501757
Expanded Access Status : Approved for marketing
First Posted : August 6, 2020
Last Update Posted : April 14, 2021
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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.


Condition or disease Intervention/treatment
High-Risk Neuroblastoma Biological: Naxitamab/GM-CSF

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Study Type : Expanded Access
Expanded Access Type : Treatment IND/Protocol
Official Title: Expanded Access Use of Naxitamab/GM-CSF Immunotherapy for Consolidation of Complete Remission or Relapsed/Refractory High-Risk Neuroblastoma



Intervention Details:
  • Biological: Naxitamab/GM-CSF
    naxitamab/GM-CSF for 5 Cycles

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04501757


Locations
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United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Brian Kushner, MD Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT04501757    
Other Study ID Numbers: 20-227
First Posted: August 6, 2020    Key Record Dates
Last Update Posted: April 14, 2021
Last Verified: April 2021
Keywords provided by Memorial Sloan Kettering Cancer Center:
Remission High-Risk Neuroblastoma
Relapsed/Refractory High-Risk Neuroblastoma
Naxitamab
GM-CSF
20-227
Additional relevant MeSH terms:
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Neuroblastoma
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue