Naxitamab and GM-CSF in People With Neuroblastoma


Study First Submitted Date 2020-07-30
Study First Posted Date 2020-08-06
Last Update Posted Date 2022-12-08
Verification Month Year December 2022
Verification Date 2022-12-31
Last Update Posted Date 2022-12-08


Sequence: 199475486
Name Memorial Sloan Kettering Cancer Center
City New York
State New York
Zip 10065
Country United States


Sequence: 52023287
Name High-Risk Neuroblastoma
Downcase Name high-risk neuroblastoma

Id Information

Sequence: 40042720
Id Source org_study_id
Id Value 20-227


Sequence: 42439913
Name United States
Removed False


Sequence: 52335651
Intervention Type Biological
Name Naxitamab/GM-CSF
Description naxitamab/GM-CSF for 5 Cycles


Sequence: 79630183 Sequence: 79630184 Sequence: 79630185 Sequence: 79630186 Sequence: 79630187
Name Remission High-Risk Neuroblastoma Name Relapsed/Refractory High-Risk Neuroblastoma Name Naxitamab Name GM-CSF Name 20-227
Downcase Name remission high-risk neuroblastoma Downcase Name relapsed/refractory high-risk neuroblastoma Downcase Name naxitamab Downcase Name gm-csf Downcase Name 20-227

Browse Conditions

Sequence: 192899735 Sequence: 192899736 Sequence: 192899737 Sequence: 192899738 Sequence: 192899739 Sequence: 192899740 Sequence: 192899741 Sequence: 192899742 Sequence: 192899743 Sequence: 192899744
Mesh Term Neuroblastoma Mesh Term Neuroectodermal Tumors, Primitive, Peripheral Mesh Term Neuroectodermal Tumors, Primitive Mesh Term Neoplasms, Neuroepithelial Mesh Term Neuroectodermal Tumors Mesh Term Neoplasms, Germ Cell and Embryonal Mesh Term Neoplasms by Histologic Type Mesh Term Neoplasms Mesh Term Neoplasms, Glandular and Epithelial Mesh Term Neoplasms, Nerve Tissue
Downcase Mesh Term neuroblastoma Downcase Mesh Term neuroectodermal tumors, primitive, peripheral Downcase Mesh Term neuroectodermal tumors, primitive Downcase Mesh Term neoplasms, neuroepithelial Downcase Mesh Term neuroectodermal tumors Downcase Mesh Term neoplasms, germ cell and embryonal Downcase Mesh Term neoplasms by histologic type Downcase Mesh Term neoplasms Downcase Mesh Term neoplasms, glandular and epithelial Downcase Mesh Term neoplasms, nerve tissue
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor


Sequence: 48181125
Agency Class OTHER
Lead Or Collaborator lead
Name Memorial Sloan Kettering Cancer Center

Overall Officials

Sequence: 29200052
Role Principal Investigator
Name Brian Kushner, MD
Affiliation Memorial Sloan Kettering Cancer Center


Sequence: 30678574
Gender All
Minimum Age 18 Months
Maximum Age N/A
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
Adult True
Child True
Older Adult True

Calculated Values

Sequence: 253874373
Number Of Facilities 1
Registered In Calendar Year 2020
Were Results Reported False
Has Us Facility True
Has Single Facility True
Minimum Age Num 18
Minimum Age Unit Months


Sequence: 4374827
Description Memorial Sloan Kettering Cancer Center

Responsible Parties

Sequence: 28791850
Responsible Party Type Sponsor