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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT06664151
Phase
EARLY_PHASE1
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Fluzone Trivalent — BIOLOGICAL
    Inactivated influenza vaccine, 0.5mL single-dose, pre-filled syringe, via intratumoral (into a tumor) injection per protocol.

Study Details

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)

Key Dates

Start date
Nov 26, 2024
Status verified
Oct 2025
Primary completion
Aug 30, 2026
Completion
Aug 30, 2026

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Fluzone Vaccine in Cutaneous Squamous Cell Carcinoma
    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

Primary Outcome Measure

Mean Percent Change of CD8+ T-cells Density [ Time Frame: Up to 15 Days ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02215
Karam Khaddour, MD
[email protected]
617-632-6571
Karam Khaddour, MD (PRINCIPAL_INVESTIGATOR)
Dana-Farber Cancer InstituteBostonMassachusetts02215
Karam Khaddour, MD
[email protected]
617-632-6571
Karam Khaddour, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Skin cancer
By specialty
OncologySkin cancerDermatology
By research site
Brigham and Women's Hospital· Boston, MADana-Farber Cancer Institute· Boston, MA

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