Actively Recruiting
Phase 0 Study of Flu Vaccine Injection into Skin Squamous Cell Carcinoma Tumors Before Surgery to Boost Immune Response
Led by Dana-Farber Cancer Institute · Updated on 2025-10-02
25
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
A Phase 0 Window of Opportunity Trial of Intratumoral Seasonal Influenza Immunization in Cutaneous Squamous Cell Carcinoma (CSCC) Patients Awaiting Curative Excision
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of cutaneous squamous cell carcinoma confirmed by biopsy, including mixed histology types
- Skin tumor measuring between 10 mm and 39 mm by clinical exam
- Candidate for Mohs micrographic surgery to remove tumor
- Age 18 years or older
- ECOG performance status of 3 or less (Karnofsky score 40% or higher)
- Ability to understand and sign informed consent
- For participants with HIV, must be on effective therapy with undetectable viral load in past 6 months
- For participants with chronic hepatitis B, viral load must be undetectable on therapy if needed
- For participants with hepatitis C, must be cured or have undetectable viral load if on treatment
You will not qualify if you...
- Tumors with high-risk features such as peri-neural invasion over 0.1 mm, invasion beyond subcutaneous fat, or larger than 3.9 cm
- Evidence of metastases from CSCC currently or in the past
- History of solid organ or bone marrow transplant
- Allergic reactions to seasonal flu vaccine
- History of Guillain-Barré syndrome
- Uncontrolled illnesses including severe heart disease
- Receiving other investigational cancer treatments
- History of other malignancy that could interfere with study assessments
- Psychiatric or social conditions limiting study compliance
- Women of child-bearing potential and men must agree to use contraception during and after study
- Pregnant or nursing women
- Previous flu vaccination is allowed but not required or prohibited
Research Team
K
Karam Khaddour, MD
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here