- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04501757
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Expanded Access Type
- Treatment IND/Protocol
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Collaborators and Investigators
Publications and helpful links
Helpful Links
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-227 (Other Identifier: Dana-Farber Cancer Institute)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on High-Risk Neuroblastoma
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Stephan Grupp MD PhDChildren's Hospital of Philadelphia; University of Pennsylvania; Tmunity TherapeuticsRecruitingRefractory Neuroblastoma | High-risk Neuroblastoma | Relapsed NeuroblastomaUnited States
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Memorial Sloan Kettering Cancer CenterRecruitingNeuroblastoma | High-risk Neuroblastoma | Metastatic NeuroblastomaUnited States
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Children's Oncology GroupNational Cancer Institute (NCI)Active, not recruitingRecurrent Neuroblastoma | Refractory Neuroblastoma | High Risk NeuroblastomaUnited States, Canada, Puerto Rico, Australia, New Zealand
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Giselle ShollerY-mAbsRecruitingHigh-risk NeuroblastomaUnited States, Canada
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Samsung Medical CenterMinistry of Health, Republic of KoreaUnknownHigh Risk Neuroblastoma
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Gustave Roussy, Cancer Campus, Grand ParisRecruitingHigh-Risk NeuroblastomaFrance, Spain, United Kingdom, Norway, Sweden, Finland, Australia, Czechia, Italy, Netherlands, Slovenia, Switzerland, Belgium, Denmark, Greece, Lithuania
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BeiGeneCompleted
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National Cancer Institute (NCI)CompletedHigh Risk NeuroblastomaUnited States
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Gustave Roussy, Cancer Campus, Grand ParisNational Cancer Institute, FranceTerminatedVery High Risk NeuroblastomaItaly, Austria, France, Netherlands, Spain
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National Cancer Institute (NCI)Active, not recruitingGanglioneuroblastoma | High Risk NeuroblastomaUnited States, New Zealand, Australia
Clinical Trials on Naxitamab/GM-CSF
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Y-mAbs TherapeuticsRecruitingNeuroblastomaSpain, Denmark, United States, Italy, United Kingdom, Germany, Hong Kong, Canada, France
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SciClone PharmaceuticalsNot yet recruiting
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Y-mAbs TherapeuticsWithdrawnNeuroblastomaKorea, Republic of, Singapore, Hong Kong, Russian Federation
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Vietnam National UniversityCompleted
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Nationwide Children's HospitalEunice Kennedy Shriver National Institute of Child Health and Human Development...RecruitingPediatric Sepsis-induced Multiple Organ Dysfunction SyndromeUnited States
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Eastern Cooperative Oncology GroupCompletedAdult Patients (Over 55) With Acute Non-Lymphocytic Leukemia
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University Hospital TuebingenCompletedMalignant MelanomaGermany
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San Antonio Military Medical CenterNuGenerex Immuno-Oncology; Norwell, Inc.CompletedBreast CancerUnited States, Germany, Greece
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Sun Yat-sen UniversityHainan General HospitalRecruiting
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Edward NelsonCompletedPancreatic Cancer | Resectable Pancreatic AdenocarcinomaUnited States