Actively Recruiting
A Phase 0 Window of Opportunity Trial of Intratumoral Seasonal Influenza Immunization in Cutaneous Squamous Cell Carcinoma (CSCC) Patients Awaiting Curative Excision
Led by Dana-Farber Cancer Institute · Updated on 2025-10-02
25
Participants Needed
2
Research Sites
91 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official 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 size between 10 and 39 mm in longest dimension by clinical exam
- Candidate for treatment by Mohs micrographic surgery
- Age 18 years or older
- ECOG performance status 0 to 3 (Karnofsky 40% or higher)
- Ability and willingness to sign informed consent
- For HIV patients, on effective anti-retroviral therapy with undetectable viral load within 6 months
- For hepatitis B patients, undetectable viral load on suppressive therapy if needed
- For hepatitis C patients, treated and cured or currently on treatment with undetectable viral load
You will not qualify if you...
- High-risk CSCC features such as peri-neural invasion >0.1 mm, invasion beyond subcutaneous fat, or tumor diameter over 3.9 cm
- Evidence of metastases including in-transit/satellite, nodal, or distant from CSCC
- History of solid organ or allogeneic bone marrow transplant
- History of allergic reactions to seasonal flu vaccine
- History of Guillain-Barré syndrome
- Uncontrolled illnesses including severe cardiac disease or recent myocardial infarction
- Receiving other investigational cancer treatments
- Past malignancies likely to interfere with study safety or efficacy assessments
- Psychiatric or social conditions limiting study compliance
- Women of child-bearing potential and men must agree to use contraception during and after the study
- Pregnant or nursing women
- Routine flu vaccination history does not exclude participation
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215
Actively Recruiting
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
K
Karam Khaddour, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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