Phase 0 Study of Flu Vaccine Injection into Skin Squamous Cell Carcinoma Tumors Before Surgery to Boost Immune Response

What this Trial Is About

Researchers are studying the effects of injecting the seasonal influenza vaccine directly into cutaneous squamous cell carcinoma CSCC tumors before patients undergo standard Mohs excision surgery. This Phase 0, window-of-opportunity trial aims to understand if the influenza vaccine can boost the immune systems response against this type of skin cancer. The study involves adults diagnosed with CSCC who are preparing for curative surgery. Participants will receive the Fluzone influenza vaccine injected into their tumor on days 1 and 8. On day 15, they will have the standard Mohs micrographic surgery to remove the tumor, with tissue collected for analysis. Follow-up visits occur on day 21 for suture removal and day 38 to monitor recovery and any effects. During the study, participants will have blood tests, tumor measurements, and photographs taken to track changes. Researchers will assess immune cell changes, tumor size, and safety outcomes up to 38 days. The main measurement is the change in CD8 T-cell density within the tumor. Participants will be monitored closely throughout the trial, which is expected to include 25 people.

A Phase 0 Window of Opportunity Trial of Intratumoral Seasonal Influenza Immunization in Cutaneous Squamous Cell Carcinoma (CSCC) Patients Awaiting Curative Excision