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Cancer Vaccine

Flu Shot for Skin Cancer

Phase < 1

Recruiting

Led By Karam Khaddour, MD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must be candidates for treatment (excision) by Mohs micrographic surgery.

Age ≥18 years.

Must not have

CSCC with high-risk features including peri-neural invasion of >0.1 mm caliber, invasion of tissue beyond the subcutaneous fat, and a diameter > 3.9 cm.

Evidence of in-transit/satellite, nodal, or distant metastases from CSCC.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 38 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is looking at how injecting the flu shot into skin cancer tumors before surgery can affect the immune system's response to the cancer. The goal is to see if the flu shot can help the immune

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include typical reactions to a flu shot like soreness at injection site, fever, fatigue, headache and muscle pain but occurring in the area where the tumor is located.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am eligible for skin cancer removal surgery.

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I am 18 years old or older.

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

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I have HIV but am on effective treatment with an undetectable viral load.

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My chronic hepatitis B virus infection is under control with undetectable viral load.

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My skin tumor is between 10 and 39 mm in size.

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I can care for myself but may not be able to do any physical work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I have had a solid organ or bone marrow transplant.

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I have had Guillain-Barré syndrome in the past.

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I do not have any uncontrolled illnesses, including heart conditions.

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I have had cancer before that might affect this treatment's safety or results.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 38 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 38 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 38 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean Percent Change of CD8+ T-cells Density

Secondary study objectives

Adverse Events

Change in Tumor Diameter

Mean Percent Change of Tumor Microenvironment Markers Compared Before and After Intratumoral Influenza Vaccination

Side effects data

From 2023 Phase 4 trial • 267 Patients • NCT05007041

COVID-19 Infection

Upper Respiratory Infection

Cardiovascular Accident (CVA), Unspecified Mechanism

Left partial cranial nerve III palsy

Acute Hyperkalemia

Shortness of Breath

Acute pulmonary embolism and acute deep vein thrombosis

100%

80%

60%

40%

20%

Study treatment Arm

Recombinant Zoster Vaccine (RZV) and High-Dose Quadrivalent Influenza Vaccine

Recombinant Zoster Vaccine (RZV) and Quadrivalent Adjuvanted Influenza Vaccine

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Fluzone Vaccine in Cutaneous Squamous Cell CarcinomaExperimental Treatment1 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

0 / 13Eligibility criteria met