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

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorDana-Farber Cancer Institute

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Fluzone Trivalent

Treatment groups

25 Participants
are divided into 1 treatment group

Sponsors and collaborators