Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00210470
Status:
COMPLETED
Last Update Posted:
2020-12-11
First Post:
2005-09-13
Brief Title:
A Phase 2 Clinical Trial of the Safety and Effects of IRX-2 in Treating Patients With Operable Head and Neck Cancer
Sponsor:
Brooklyn ImmunoTherapeutics LLC
Organization:
Brooklyn ImmunoTherapeutics LLC
Study Overview
Official Title:
A Phase 2 Open-label Trial of the Safety and Biological Effect of Subcutaneous IRX-2 With Cyclophosphamide Indomethacin and Zinc in Patients With Resectable Cancer of the Head and Neck
Status:
COMPLETED
Status Verified Date:
2020-12
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 was a Phase 2a trial to investigate the safety and biological activity of the RIX-2 Regimen in patients with untreated resectable squamous cell cancer of the head and neck HNSCC
Detailed Description:
IRX-2 is a primary cell-derived biologic that reduces the immune suppression that is often seen in the cancer tumor micro-environment restores immune function and activates a coordinated immune response against the tumor IRX-2 is a complex proprietary therapeutic containing numerous active cytokine components which restores and activates multiple immune cell types including T cells dendritic cells and natural killer cells to recognize and destroy tumors
The present study administered the IRX-2 Regimen to 27 patients as a neoadjuvant before surgery therapy and the main objective of the study was to determine the safety and tolerability of the IRX-2 regimen
The present study administered the IRX-2 Regimen to 27 patients as a neoadjuvant before surgery therapy and the main objective of the study was to determine the safety and tolerability of the IRX-2 regimen
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?:
None
Is an FDA AA801 Violation?:
None