Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06338657
Status:
RECRUITING
Last Update Posted:
2024-05-17
First Post:
2024-03-14
Brief Title:
FID-007 Followed by Standard of Care Surgery in Head and Neck Cancer
Sponsor:
University of Southern California
Organization:
University of Southern California
Study Overview
Official Title:
A Window of Opportunity Study of Taxanes in Head and Neck Cancer
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase I trial studies on how the PEOX-based polymer encapsulated paclitaxel FID-007 FID-007 affects the immune cells around the tumor patients with head and neck squamous cell carcinoma The active drug in FID-007 is paclitaxel an established chemotherapy drug that has been shown to kill cancer cells FID-007 is a packaged form of paclitaxel using a polyethylozaxoline PEOX polymer which may allow the drug to reach deeper into tumors and less into normal cells by being smaller This study is being done to help identify future treatment options and better understand how to improve outcomes of patients with head and neck cancers after surgery
Detailed Description:
PRIMARY OBJECTIVE
I To describe the phenotypical and functional changes of different T cell subsets within the tumor microenvironment after treatment with FID-007
SECONDARY OBJECTIVES
I To describe the adverse events associated with neoadjuvant FID-007 prior to surgery for head and neck cancer
II To evaluate preliminary evidence of efficacy by describing the rate of major and complete pathologic response
III To describe the rates of locoregional recurrence and rate of distant metastasis at 2 years after surgery
EXPLORATORY OBJECTIVE
I Explore association between pathologic response and phenotypical and functional changes in T cell subsets
OUTLINE
Patients receive FID-007 intravenously IV over 30 minutes once a week for 3 weeks on days 1 8 and 15 of a single 28 day cycle in the absence of disease progression or unacceptable toxicity Patients then undergo standard of care surgery Patients undergo computed tomography CT or magnetic resonance imaging MRI during screening and blood sample collection throughout the study
After completion of study treatment patients are followed up every 3 months for 2 years
I To describe the phenotypical and functional changes of different T cell subsets within the tumor microenvironment after treatment with FID-007
SECONDARY OBJECTIVES
I To describe the adverse events associated with neoadjuvant FID-007 prior to surgery for head and neck cancer
II To evaluate preliminary evidence of efficacy by describing the rate of major and complete pathologic response
III To describe the rates of locoregional recurrence and rate of distant metastasis at 2 years after surgery
EXPLORATORY OBJECTIVE
I Explore association between pathologic response and phenotypical and functional changes in T cell subsets
OUTLINE
Patients receive FID-007 intravenously IV over 30 minutes once a week for 3 weeks on days 1 8 and 15 of a single 28 day cycle in the absence of disease progression or unacceptable toxicity Patients then undergo standard of care surgery Patients undergo computed tomography CT or magnetic resonance imaging MRI during screening and blood sample collection throughout the study
After completion of study treatment patients are followed up every 3 months for 2 years
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30CA014089 | NIH | USC Norris Comprehensive Cancer Center | httpsreporternihgovquickSearchP30CA014089 |
| NCI-2024-01367 | REGISTRY | None | None |
| 7H-23-5 | OTHER | None | None |