Skin Cancer study: Fluzone Trivalent
Official title A Phase 0 Window of Opportunity Trial of Intratumoral Seasonal Influenza Immunization in Cutaneous Squamous Cell Carcinoma (CSCC) Patients Awaiting Curative Excision
ClinicalTrials.gov ID: NCT06664151
What this study is testing
What is Fluzone Trivalent?
Fluzone Trivalent is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for skin cancer.
Also referred to as Influenza Vaccine, Flu shot.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see how giving the flu vaccine directly into the tumor changes immune cells and whether it might boost the body’s response to the cancer.
- Who it's for
- People with cutaneous squamous cell carcinoma who are scheduled for Mohs excision surgery.
- What's involved
- Participants receive a single injection of the flu vaccine into the tumor, then undergo their usual surgery. Blood and tissue samples may be taken to study immune effects.
- Time commitment
- One pre‑surgery visit for the injection and sample collection, followed by the standard surgical appointment.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants must have a diagnosis of cutaneous squamous cell carcinoma that has been biopsied and confirmed histologically.
- 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 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).
You likely can't join if
- CSCC with the following high-risk features including peri-neural invasion of \>0.1 mm caliber, and invasion of tissue beyond the subcutaneous fat...
- Evidence of in-transit/satellite, nodal, or distant metastases from CSCC, in the present or in the past medical history, including evidence from...
- 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...
See the full eligibility criteria
- 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 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.
- 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...
- 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 how well it works assessment of the investigational regimen, according to the...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Boston, Massachusetts, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.