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)
This Phase 0, window-of-opportunity 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. This study will help understand if the addition of the influenza vaccine can improve the immune system response against the cancer. The research study procedures include screening for eligibility, in-clinic visits, blood tests, and measurements and photographs of tumors. It is expected that 25 people will take part in this research study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Inactivated influenza vaccine, 0.5mL single-dose, pre-filled syringe, via intratumoral (into a tumor) injection per protocol.
Brigham and Women's Hospital
Boston, Massachusetts, United States
RECRUITINGDana-Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITINGMean 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).
Time frame: Up to 15 Days
Change in Tumor Diameter
Evaluate the change in tumor diameter based on day 1 screening and the biopsy from the time of diagnosis.
Time frame: Up to 15 Days
Adverse Events
Adverse events rate is defined as the percentage of participants who have experienced adverse events based on CTCAE 5.0
Time frame: Up to 38 days
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
Time frame: Up to 15 Days
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