Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-25 @ 9:46 PM
Study NCT ID:
NCT06664151
Status:
RECRUITING
Last Update Posted:
2025-10-02
First Post:
2024-10-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase 0 Window of Opportunity Trial of Intratumoral Seasonal Influenza Immunization in Cutaneous Squamous Cell Carcinoma (CSCC) Patients Awaiting Curative Excision
Sponsor:
Dana-Farber Cancer Institute
Organization:
Study Overview
Official Title:
A Phase 0 Window of Opportunity Trial of Intratumoral Seasonal Influenza Immunization in Cutaneous Squamous Cell Carcinoma (CSCC) Patients Awaiting Curative Excision
Status:
RECRUITING
Status Verified Date:
2025-10
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 study is investigating the effects on immune cells of injecting the influenza vaccine (also known as "flu shot") into cutaneous squamous cell carcinoma (CSCC) tumors prior to having standard-of-care Mohs excision surgery. The study will help understand if the addition of the influenza vaccine could improve the immune system response against the cancer.
The names of the study drug involved in this study is:
-Fluzone Influenza vaccine (flu shot)
The names of the study drug involved in this study is:
-Fluzone Influenza vaccine (flu shot)
Detailed Description:
This Phase 0, window-of-opportunity study is investigating the effects on immune cells of injecting the influenza vaccine (also known as "flu shot") into cutaneous squamous cell carcinoma (CSCC) tumors prior to having standard-of-care Mohs excision surgery. This study will help understand if the addition of the influenza vaccine can improve the immune system response against the cancer.
The research study procedures include screening for eligibility, in-clinic visits, blood tests, and measurements and photographs of tumors.
It is expected that 25 people will take part in this research study.
The research study procedures include screening for eligibility, in-clinic visits, blood tests, and measurements and photographs of tumors.
It is expected that 25 people will take part in this research study.
Study Oversight
Has Oversight DMC:
True
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?: