RECRUITING

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

Conditions

Skin Cancer Cutaneous Squamous Cell Carcinoma (CSCC)Cutaneous Squamous Cell Cancer Cutaneous Squamous Cell Carcinoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Official Title

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

Quick Facts

Study Start:2024-11

Study Completion:2025-08-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06664151

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 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.	* 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, unstable angina). * 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 efficacy assessment of the investigational regimen, according to the treating investigator. * 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. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of intratumoral flu vaccine administration. Patients who do not agree to comply with these precautions are ineligible. * 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.

Inclusion Criteria

Exclusion 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 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.

* 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, unstable angina).
* 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 efficacy assessment of the investigational regimen, according to the treating investigator.
* 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. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of intratumoral flu vaccine administration. Patients who do not agree to comply with these precautions are ineligible.
* 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.

Contacts and Locations

Study Contact

Karam Khaddour, MD

CONTACT

617-632-6571

karam_khaddour@dfci.harvard.edu

Principal Investigator

Karam Khaddour, MD

PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Study Locations (Sites)

Brigham and Women's Hospital

Boston, Massachusetts, 02215

United States

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

United States

Collaborators and Investigators

Sponsor: Dana-Farber Cancer Institute

Karam Khaddour, MD, PRINCIPAL_INVESTIGATOR, Dana-Farber Cancer Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11

Study Completion Date2025-08-30

Study Record Updates

Study Start Date2024-11

Study Completion Date2025-08-30

Terms related to this study

Keywords Provided by Researchers

Skin Cancer
Cutaneous Squamous Cell Carcinoma
Cutaneous Squamous Cell Cancer

Additional Relevant MeSH Terms

Skin Cancer
Cutaneous Squamous Cell Carcinoma (CSCC)
Cutaneous Squamous Cell Cancer