Studies
| 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 |
Facilities
| Sequence: | 199475486 |
| Name | Memorial Sloan Kettering Cancer Center |
| City | New York |
| State | New York |
| Zip | 10065 |
| Country | United States |
Conditions
| Sequence: | 52023287 |
| Name | High-Risk Neuroblastoma |
| Downcase Name | high-risk neuroblastoma |
Id Information
| Sequence: | 40042720 |
| Id Source | org_study_id |
| Id Value | 20-227 |
Countries
| Sequence: | 42439913 |
| Name | United States |
| Removed | False |
Interventions
| Sequence: | 52335651 |
| Intervention Type | Biological |
| Name | Naxitamab/GM-CSF |
| Description | naxitamab/GM-CSF for 5 Cycles |
Keywords
| 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 |
Sponsors
| 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 |
Eligibilities
| 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 |
Links
| Sequence: | 4374827 |
| Url | http://www.mskcc.org/mskcc/html/44.cfm |
| Description | Memorial Sloan Kettering Cancer Center |
Responsible Parties
| Sequence: | 28791850 |
| Responsible Party Type | Sponsor |