RecruitingEarly Phase 1NCT06664151

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

Enrollment

25 participants

Start Date

Nov 26, 2024

Study Type

INTERVENTIONAL

Conditions

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)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether injecting the seasonal influenza (flu) vaccine directly into a skin squamous cell carcinoma tumor — a type of skin cancer — can trigger an immune response that helps fight the cancer before surgical removal. It is a short "window of opportunity" trial: participants receive the injection and then proceed to their planned cancer surgery. **You may be eligible if...** - You are 18 or older - You have been diagnosed with cutaneous squamous cell carcinoma (skin cancer) confirmed by biopsy - Your skin tumor is between 10 and 39 mm in its longest dimension - You are scheduled for Mohs surgery (a precise type of skin cancer removal) - You are generally in good enough health to participate **You may NOT be eligible if...** - Your skin tumor is smaller than 10 mm or larger than 39 mm - You are not a candidate for Mohs surgery - You are under 18 (this cancer type is extremely rare in children) - You have HIV with a detectable viral load, or uncontrolled hepatitis B or C Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALFluzone Trivalent

Inactivated influenza vaccine, 0.5mL single-dose, pre-filled syringe, via intratumoral (into a tumor) injection per protocol.


Locations(2)

Brigham and Women's Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

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NCT06664151


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