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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY

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)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• 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.

Locations
United States
Massachusetts
Brigham and Women's Hospital
RECRUITING
Boston
Dana-Farber Cancer Institute
RECRUITING
Boston
Contact Information
Primary
Karam Khaddour, MD
karam_khaddour@dfci.harvard.edu
617-632-6571
Time Frame
Start Date: 2024-11-26
Estimated Completion Date: 2026-08-30
Participants
Target number of participants: 25
Treatments
Experimental: Fluzone Vaccine in Cutaneous Squamous Cell Carcinoma
Enrolled participants will complete:~* Baseline visit~* Days 1 and 8: Flu shot injection once~* Day 15: Standard-of-care Mohs excision surgery and tissue collection.~* Day 21 follow up visit with suture removal.~* Day 38 follow up visit
Related Therapeutic Areas
Sponsors
Leads: Dana-Farber Cancer Institute

This content was sourced from clinicaltrials.gov