Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06438614
Status:
COMPLETED
Last Update Posted:
2024-06-03
First Post:
2024-03-21
Brief Title:
A Study Of Naxitamab Granulocyte Macrophage Colony Stimulating Factor For Patients With Relapsed Refractory Soft Tissue or Anti GD2 Immunotherapy Refractory Neuroblastoma
Sponsor:
Fundació Sant Joan de Déu
Organization:
Fundació Sant Joan de Déu
Study Overview
Official Title:
A Phase II Single Center Study Of Naxitamab Granulocyte Macrophage Colony Stimulating Factor GM CSF and Ifosfamide Carboplatin Etoposide For Patients With Relapsed Refractory Soft Tissue or Anti GD2 Immunotherapy Refractory Neuroblastoma
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NICE
Brief Summary:
The purpose of this study is to evaluate safety and efficacy of naxitamab granulocyte macrophage Colony Stimulating Factor GM CSF and IsofosfamideCarboplatinEtoposide NICE for Patients With Relapsed Refractory soft tissue or anti GD2 immunotherapy refractory Neuroblastoma
Detailed Description:
The anti-GD2 monoclonal antibody Naxitamab also known as hu3F8 in combination with macrophage colony-stimulating factor GM-CSF is currently under pivotal phase 3 investigation for the treatment of High-Risk Neuroblastoma Patients with Primary or Secondary Refractory Osteomedullary Disease
A subset of patients with high-risk resistant disease ie relapsed or refractory Neuroblastoma with soft tissue involvement as measured by 123I-Meta-iodobenzylguanidine MIBG 18F-FDG avid or measurable computed tomography CT magnetic resonance imaging MRI tumors outside of the bone marrow or disease refractory to Naxitamab in combination with GM-CSF has shown significant response rates to a chemoimmunotherapy combination of Naxitamab GM-CSF irinotecan and temozolomide HITS- Hu3F8 irinotecan temozolomide and sargramostim NCT03189706 Treatment is administered on an outpatient basis and toxicities include those expected from IT myelosuppression and diarrhea as well as pain and hypertension expected with Naxitamab No other greater than grade 2 related toxicities occurred in this study n46 Early responses assessed after 2 cycles were documented in 18 39 patients and here complete n 9 partial n 8 and mixed n 1 and 13 patients had stable disease Responses were achieved in refractory 3743 and progressive disease 153938 subgroups in patients who had previously received IT 123435 andor anti-GD2 MoAb 143639 and in soft tissue 622 27 MIBG-avid skeletal sites 203656 and on bone marrow histology 91275 While encouraging new strategies are warranted to further treat resistant disease
A high-dose combination of ifosfamide carboplatin and etoposide ICE has activity against Neuroblastoma without cross-resistance to widely used chemotherapy regimens
Through compassionate use 4 patients with progression of disease or refractory disease after HITS therapy have been further treated with two cycles of a combination of naxitamab Granulocyte-Macrophage Colony Stimulating Factor GM-CSF and ifosfamideCarboplatinEtoposide NICE The first patient showed a complete response
Toxicity included G2 prolonged aplasia and G3 hypertension both expected from the chemotherapy agents and hu3F8 One patient progressed after the 2 cycles and the other 2 showed stable disease according to the revised 2017 International Neuroblastoma Response Criteria INRC
In this formal trial the investigators will investigate whether the combination of Naxitamab and GM-CSF with ifosfamideCarboplatinEtoposide ICE has a synergistic treatment effect in relapsed or refractory disease The safety and efficacy of NICE Naxitamab IfosfamideCarboplatinEtoposide in patients that have not achieved complete remission with HITS chemo-immunotherapy will be assessed
A subset of patients with high-risk resistant disease ie relapsed or refractory Neuroblastoma with soft tissue involvement as measured by 123I-Meta-iodobenzylguanidine MIBG 18F-FDG avid or measurable computed tomography CT magnetic resonance imaging MRI tumors outside of the bone marrow or disease refractory to Naxitamab in combination with GM-CSF has shown significant response rates to a chemoimmunotherapy combination of Naxitamab GM-CSF irinotecan and temozolomide HITS- Hu3F8 irinotecan temozolomide and sargramostim NCT03189706 Treatment is administered on an outpatient basis and toxicities include those expected from IT myelosuppression and diarrhea as well as pain and hypertension expected with Naxitamab No other greater than grade 2 related toxicities occurred in this study n46 Early responses assessed after 2 cycles were documented in 18 39 patients and here complete n 9 partial n 8 and mixed n 1 and 13 patients had stable disease Responses were achieved in refractory 3743 and progressive disease 153938 subgroups in patients who had previously received IT 123435 andor anti-GD2 MoAb 143639 and in soft tissue 622 27 MIBG-avid skeletal sites 203656 and on bone marrow histology 91275 While encouraging new strategies are warranted to further treat resistant disease
A high-dose combination of ifosfamide carboplatin and etoposide ICE has activity against Neuroblastoma without cross-resistance to widely used chemotherapy regimens
Through compassionate use 4 patients with progression of disease or refractory disease after HITS therapy have been further treated with two cycles of a combination of naxitamab Granulocyte-Macrophage Colony Stimulating Factor GM-CSF and ifosfamideCarboplatinEtoposide NICE The first patient showed a complete response
Toxicity included G2 prolonged aplasia and G3 hypertension both expected from the chemotherapy agents and hu3F8 One patient progressed after the 2 cycles and the other 2 showed stable disease according to the revised 2017 International Neuroblastoma Response Criteria INRC
In this formal trial the investigators will investigate whether the combination of Naxitamab and GM-CSF with ifosfamideCarboplatinEtoposide ICE has a synergistic treatment effect in relapsed or refractory disease The safety and efficacy of NICE Naxitamab IfosfamideCarboplatinEtoposide in patients that have not achieved complete remission with HITS chemo-immunotherapy will be assessed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None