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)
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.
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.
Single group
Fluzone Trivalent
Biological/VaccineInactivated influenza vaccine, 0.5mL single-dose, pre-filled syringe, via intratumoral (into a tumor) injection per protocol.
Mean Percent Change of CD8+ T-cells Density
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).
Change in Tumor Diameter
Evaluate the change in tumor diameter based on day 1 screening and the biopsy from the time of diagnosis.
Adverse Events
Adverse events rate is defined as the percentage of participants who have experienced adverse events based on CTCAE 5.0
Mean Percent Change of Tumor Microenvironment Markers Compared Before and After Intratumoral Influenza Vaccination
Evaluation of the differences of effect on the mean percent change of tumor microenvironment markers before and after the administration of intratumoral influenza vaccine in CSCC lesions
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