Ignite Creation Date:
2024-05-06 @ 5:56 PM
Last Modification Date:
2024-10-26 @ 2:38 PM
Study NCT ID:
NCT05489887
Status:
RECRUITING
Last Update Posted:
2024-04-08
First Post:
2022-08-04
Brief Title:
Naxitamab Added to Induction for Newly Diagnosed High-Risk Neuroblastoma
Sponsor:
Giselle Sholler
Organization:
Milton S Hershey Medical Center
Study Overview
Official Title:
A Phase II Study of Naxitamab Added to Induction Therapy for Subjects With Newly Diagnosed High-Risk Neuroblastoma
Status:
RECRUITING
Status Verified Date:
2024-09
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:
None
Brief Summary:
This is a prospective multicenter clinical trial in subjects with newly diagnosed high-risk neuroblastoma to evaluate the efficacy and safety of administering naxitamab with standard induction therapy The initial chemotherapy will include 5 cycles of multi-agent chemotherapy Naxitamab will be added to all 5 Induction cycles We hypothesize that the addition of anti-GD2 therapy to induction chemotherapy will result in improved end of induction responses and improved survival
Detailed Description:
This is a prospective multicenter clinical trial in subjects with newly diagnosed high-risk neuroblastoma to evaluate the efficacy and safety of administering naxitamab with standard induction therapy
All subjects will be followed for disease response event free survival overall survival and toxicity Extent of disease will be measured and assessed for changes throughout the course of the study All efficacy analyses will be performed on the evaluable population which will consist of all enrolled subjects subjects who initiate treatment with naxitamab in combination with GM-CSF plus standard induction therapy and who have measurable disease at baseline
The initial chemotherapy Induction regimen will utilize sequential administration of 5 cycles of multi-agent chemotherapy Naxitamab will be added to all 5 Induction cycles
Stem cell mobilization and collection will occur after the 2nd cycle of induction
Surgical resection of the primary tumor will ideally occur after the 4th cycle of Induction but may be delayed until after the 5th cycle of Induction if medically necessary
Disease status evaluations will occur at the following time points 1 pre-treatment 2 post Cycle 2 Induction 3 Prior to surgical resection if performed 4 End of Induction which includes surgery and 5 cycles of chemotherapy and 5 End of AdditionalSalvage Therapy as needed
The current standard of care for high-risk neuroblastoma involves 5-7 cycles of induction chemotherapy with surgical removal of the tumor after 4-5 cycles of chemotherapy followed by high-dose chemotherapy plus autologous stem cell transplant then radiation to the primary tumor bed followed by anti-GD2 immunotherapy and cis retinoic acid This results in a less than 60 disease free survival for high-risk NB a survival rate that still greatly needs improvement Two areas in which improvements can be made include 1 to improve response rate to induction chemotherapy and 2 to improve EFS by improving maintenance therapy to prevent relapse
We hypothesize that the addition of anti-GD2 therapy to induction chemotherapy will result in improved end of induction responses and improved survival
All subjects will be followed for disease response event free survival overall survival and toxicity Extent of disease will be measured and assessed for changes throughout the course of the study All efficacy analyses will be performed on the evaluable population which will consist of all enrolled subjects subjects who initiate treatment with naxitamab in combination with GM-CSF plus standard induction therapy and who have measurable disease at baseline
The initial chemotherapy Induction regimen will utilize sequential administration of 5 cycles of multi-agent chemotherapy Naxitamab will be added to all 5 Induction cycles
Stem cell mobilization and collection will occur after the 2nd cycle of induction
Surgical resection of the primary tumor will ideally occur after the 4th cycle of Induction but may be delayed until after the 5th cycle of Induction if medically necessary
Disease status evaluations will occur at the following time points 1 pre-treatment 2 post Cycle 2 Induction 3 Prior to surgical resection if performed 4 End of Induction which includes surgery and 5 cycles of chemotherapy and 5 End of AdditionalSalvage Therapy as needed
The current standard of care for high-risk neuroblastoma involves 5-7 cycles of induction chemotherapy with surgical removal of the tumor after 4-5 cycles of chemotherapy followed by high-dose chemotherapy plus autologous stem cell transplant then radiation to the primary tumor bed followed by anti-GD2 immunotherapy and cis retinoic acid This results in a less than 60 disease free survival for high-risk NB a survival rate that still greatly needs improvement Two areas in which improvements can be made include 1 to improve response rate to induction chemotherapy and 2 to improve EFS by improving maintenance therapy to prevent relapse
We hypothesize that the addition of anti-GD2 therapy to induction chemotherapy will result in improved end of induction responses and improved survival
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?:
False
Is an FDA AA801 Violation?:
None