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Influenza Vaccine for Cutaneous Squamous Cell Carcinoma

This study is looking at whether injecting the "flu shot" (Fluzone Trivalent) directly into skin tumors (cutaneous squamous cell carcinoma or CSCC) can help your immune system fight the cancer. You might be able to join if you have CSCC that has been confirmed by a biopsy and your tumor is between 10 and 39 millimeters in size. Researchers will measure changes in certain immune cells (CD8+ T-cells) in your tumor up to 15 days after the injection to see if this approach is successful. The study is currently unclear on its recruitment status and plans to enroll 25 people.

Study design
This is an interventional study, not specifying a phase, that plans to enroll 25 participants.
What's involved
You would undergo screening, in-clinic visits, blood tests, and have your tumors measured and photographed.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures changes in immune cells up to 15 days after the intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06664151

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

Recruiting
EARLY_PHASE1Ages 18+InterventionalTreatment
Dana-Farber Cancer Institute
~25 participants
Updated 2025-10-02 on ClinicalTrials.gov
What's tested:Fluzone Trivalent

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mean Percent Change of CD8+ T-cells Density
Measured over Up to 15 Days

Conditions

Skin Cancer
Cutaneous Squamous Cell Carcinoma (CSCC)
Cutaneous Squamous Cell Cancer

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Skin Squamous Cell Carcinoma

NCT06664151

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Brigham and Women's Hospital

    Boston, Massachusettsstudy coordinator listed

    Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusettsstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Karam Khaddour, MD · PRINCIPAL_INVESTIGATOR · Dana-Farber Cancer Institute

Who to contact

Karam Khaddour, MD
[email protected]
617-632-6571
Email the study team

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Eligibility criteria

Inclusion

Participants must have a diagnosis of cutaneous squamous cell carcinoma that has been biopsied and confirmed histologically. Mixed histology (such as basosquamous carcinoma, sarcomatous carcinoma) is allowed.
Participants must have a skin tumor that measures 10 - 39 mm (not less than 10 mm and not more than 39 mm) in longest dimension by clinical exam. (Participants may have more than one untreated CSCC at the time of enrollment, but only one CSCC may be treated with the study agent.)
Participants must be candidates for treatment (excision) by Mohs micrographic surgery.
Age ≥18 years. Because CSCC is exceptionally rare in patients \<18 years of age, children are excluded from this study.
ECOG performance status ≤3 (Karnofsky ≥40%, see Appendix A).
Ability to understand and the willingness to sign a written informed consent document.
For participants with a past medical history of Human immunodeficiency virus (HIV), they must be on effective anti-retroviral therapy with undetectable viral load measured within the 6 months prior to enrollment.
For participants with a past medical history of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
For participants with a past medical history of hepatitis C virus (HCV) infection, they must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.

Exclusion

CSCC with the following high-risk features including peri-neural invasion of \>0.1 mm caliber, and invasion of tissue beyond the subcutaneous fat, and a diameter \> 3.9 cm.
Evidence of in-transit/satellite, nodal, or distant metastases from CSCC, in the present or in the past medical history, including evidence from physical exam of primary site and draining lymph node basin.
History of solid organ transplant or allogeneic bone marrow transplant.
History of allergic reactions attributed to the seasonal flu vaccine.
History of Guillain-Barré syndrome.
Participants with any uncontrolled intercurrent illness, including uncontrolled cardiac disease (New York Heart Association Class III or IV heart failure, myocardial infarction in the 6 months prior to enrollment, unstable angina).
Participants who are receiving any other investigational agents for treatment of cancer.
Participants with a past medical history of another malignancy whose natural history or treatment is likely to interfere with the safety or efficacy assessment of the investigational regimen, according to the treating investigator.
Participants with psychiatric illness/social situations that would limit compliance with study requirements.
Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of intratumoral flu vaccine administration. Patients who do not agree to comply with these precautions are ineligible.
Pregnant or nursing (breast-feeding) women are excluded from this study because there is an unknown but potential risk to multiple injections of flu vaccine in pregnant or nursing women.
Note: Previous treatment with flu vaccination is not an exclusion criterion. Routine intramuscular seasonal influenza vaccination is not required nor prohibited.

What this trial measures

  • Mean Percent Change of CD8+ T-cells DensityUp to 15 Days

    CD8+ T-cell infiltration density (as measured by cells/mm2) on tumors is collected at the time of Mohs micrographic surgery compared to baseline (time of diagnostic biopsy).