Flu Shot for Skin Cancer

Recruiting at 1 trial location

Overseen By Karam Khaddour, MD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Dana-Farber Cancer Institute

Must not be taking: Investigational cancer agents

Disqualifiers: Organ transplant, Guillain-Barré, uncontrolled illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: 2 weeks

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether injecting a flu shot directly into skin cancer tumors can boost the body's immune response before standard cancer surgery. It specifically targets individuals with cutaneous squamous cell carcinoma to determine if the flu vaccine can enhance cancer treatment. Participants must have a confirmed diagnosis of this skin cancer, with a tumor size between 10 and 39 mm, and plan to undergo Mohs surgery, a precise technique for skin cancer removal. As an Early Phase 1 trial, this research aims to understand how the treatment works in people, offering participants a chance to contribute to groundbreaking cancer research.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on investigational cancer treatments, you may not be eligible to participate.

What prior data suggests that the Fluzone Influenza vaccine is safe for use in this study?

Research shows that the flu shot, officially called the influenza vaccine, is generally safe for people. The Fluzone flu vaccine, used in this study, has been administered to many individuals to prevent the flu and has a strong safety record. Studies have found that this vaccine is safe even for cancer patients taking medications that affect their immune systems. These patients do not face a higher risk of serious immune reactions.

This trial explores a new approach by injecting the flu shot directly into skin cancer tumors. Although this method is new, the vaccine itself is known to be well-tolerated. Current evidence suggests that using the flu shot in this way should be safe, but specific data on this use is still being gathered. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for skin cancer?

Researchers are excited about using the Fluzone influenza vaccine for treating cutaneous squamous cell carcinoma because it offers a novel approach that differs from the typical surgical and radiation treatments. Unlike standard treatments that primarily focus on removing or destroying cancer cells, the flu vaccine might stimulate the immune system to recognize and attack cancer cells more effectively. This potential immunotherapeutic effect is what sets it apart, as it could enhance the body’s natural defenses to fight the cancer with minimal invasiveness. If successful, this approach could lead to quicker recovery times and reduced side effects compared to traditional cancer treatments.

What evidence suggests that the flu shot might be an effective treatment for skin cancer?

Research has shown that injecting the flu shot directly into tumors might help the immune system fight cancer. In this trial, participants will receive the Fluzone vaccine as part of their treatment for cutaneous squamous cell carcinoma. Some studies have found that flu vaccines can be safe and helpful for cancer patients, improving their ability to fight infections. Early results suggest this method could shrink tumors by activating immune cells. The flu shot may help the body better recognize and attack cancer cells. Although it's too soon for firm conclusions, this approach appears promising based on current research. ^{1 3 5 6 7}

Who Is on the Research Team?

Karam Khaddour, MD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

This trial is for patients with cutaneous squamous cell carcinoma (CSCC), a type of skin cancer, who are scheduled for Mohs surgery. Participants should not have received the flu shot recently or be allergic to it.

Inclusion Criteria

My skin cancer has been confirmed by a biopsy.

I am eligible for skin cancer removal surgery.

I had hepatitis C but am cured, or I'm being treated with no detectable virus.

Exclusion Criteria

History of allergic reactions attributed to the seasonal flu vaccine.

My skin cancer has spread to nearby lymph nodes or other parts of the body.

My skin cancer is aggressive, invading deep tissues or is larger than 3.9 cm.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants receive the Fluzone influenza vaccine injected into CSCC tumors

2 weeks

3 visits (in-person)

Surgery

Participants undergo standard-of-care Mohs excision surgery and tissue collection

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including suture removal and additional follow-up

3 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Fluzone Influenza vaccine

Trial Overview The study tests injecting the Fluzone influenza vaccine directly into CSCC tumors before surgical removal. It aims to see if this can boost the body's immune response against cancer cells.

How Is the Trial Designed?

Group I: Fluzone Vaccine in Cutaneous Squamous Cell Carcinoma Experimental Treatment 1 Intervention

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

Fluzone Influenza vaccine is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Fluzone for:

• Influenza prophylaxis

Approved in European Union as Fluzone for:

• Influenza prophylaxis

Approved in Canada as Fluzone for:

• Influenza prophylaxis

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Published Research Related to This Trial

In a study of 127 lung cancer patients receiving nivolumab, influenza vaccination did not significantly increase the incidence of immune-related adverse events (irAEs) compared to non-vaccinated patients, with rates of 26% for vaccinated and 22% for non-vaccinated individuals.

The study found no significant differences in serious irAEs, treatment discontinuation, death, or tumor response between vaccinated and non-vaccinated groups, suggesting that influenza vaccination is safe and should be encouraged for lung cancer patients undergoing anti-PD-1 therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influenza vaccination in patients with lung cancer receiving anti-programmed death receptor 1 immunotherapy does not induce immune-related adverse events. Wijn, DH., Groeneveld, GH., Vollaard, AM., et al.[2019]

Fluzone Intradermal Quadrivalent vaccine, introduced for the 2015-2016 season, includes two B-strain lineage viruses, enhancing its effectiveness against influenza by providing broader protection.

The vaccine utilizes a unique microinjection system, which not only improves the delivery method but also aims to alleviate logistical challenges for healthcare providers during vaccination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fluzone® Intradermal Quadrivalent Influenza Vaccine. Robertson, CA., Tsang, P., Landolfi, VA., et al.[2018]

Fluzone Intradermal, approved by the FDA in 2011, is the first influenza vaccine in the USA that uses a microinjection system for intradermal delivery, requiring a lower antigen content (9 µg) compared to conventional intramuscular vaccines (15 µg).

Clinical trials demonstrated that Fluzone Intradermal is safe and has immunogenicity comparable to traditional intramuscular vaccines, which may help improve influenza vaccination rates among adults aged 18 to 64.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fluzone(®) Intradermal vaccine: a promising new chance to increase the acceptability of influenza vaccination in adults. Ansaldi, F., de Florentiis, D., Durando, P., et al.[2011]

Fluzone High-Dose is an injectable influenza vaccine specifically designed for individuals aged 65 and older, containing a higher amount of hemagglutinin antigen to improve immune response compared to standard vaccines.

The FDA approved Fluzone High-Dose for this age group due to their increased risk of severe influenza outcomes, although the Advisory Committee on Immunization Practices did not express a preference for it over other vaccines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Licensure of a high-dose inactivated influenza vaccine for persons aged >or=65 years (Fluzone High-Dose) and guidance for use - United States, 2010. [2017]

The intradermal (ID) influenza vaccine demonstrated immune responses comparable to the intramuscular (IM) vaccine in a study of 4292 adults, meeting non-inferiority criteria for antibody levels against all three virus strains tested (H1N1, H3N2, and B).

While local injection site reactions were more frequent with the ID vaccine, they were mostly mild and transient, indicating that the ID vaccine is a well-tolerated alternative to the IM vaccine despite slightly higher rates of local discomfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intradermally-administered influenza virus vaccine is safe and immunogenic in healthy adults 18-64 years of age. Gorse, GJ., Falsey, AR., Fling, JA., et al.[2018]

The Fluzone Intradermal (ID) vaccine was found to be as immunogenic as the standard intramuscular (IM) vaccine, showing no significant differences in antibody responses for all three viral strains tested.

While the ID vaccine had higher rates of local reactions like erythema and swelling compared to the IM vaccine, it was well-tolerated overall, with no serious adverse events reported, indicating it can be safely used for annual revaccination in adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of revaccination with reduced dose intradermal and standard dose intramuscular influenza vaccines in adults 18-64 years of age. Gorse, GJ., Falsey, AR., Johnson, CM., et al.[2013]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06664151

Study Details | NCT06664151 | A Phase 0 Window of ... This study is investigating the effects on immune cells of injecting the influenza vaccine (also known as "flu shot") into cutaneous squamous cell carcinoma ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8365730/

Influenza vaccination in cancer patients receiving immune ... The aim of this systematic review was to summarize the available data on the safety and efficacy of influenza vaccination in cancer patients receiving ICIs.

3. dana-farber.org dana-farber.org/clinical-trials/24-491

A Phase 0 window of opportunity trial of intratumoral ... This study is investigating the effects on immune cells of injecting the influenza vaccine (also known as "flu shot") into cutaneous squamous cell carcinoma ...

4. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-09576

Intratumoral Trivalent Influenza Vaccine for the Treatment ... This early phase I trial studies how well giving the seasonal flu shot (trivalent influenza vaccine) in the tumor (intratumoral) works in shrinking ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9412390/

Safety and Efficacy of Influenza Vaccination in Patients ... Vaccination against influenza is safe, reduces mortality and improves infection-related outcomes among adults with cancer [11,12]. Consequently, annual ...

6. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/549537

A Phase 0 Window of Opportunity Trial of Intratumoral ... This study is investigating the effects on immune cells of injecting the influenza vaccine (also known as "flu shot") into cutaneous ...

7. trial.medpath.com trial.medpath.com/drug/6ff9869c314fbf0e/fluzone

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