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Trial Title:
A Phase 0 Window of Opportunity Trial of Intratumoral Seasonal Influenza Immunization in Cutaneous Squamous Cell Carcinoma (CSCC) Patients Awaiting Curative Excision
NCT ID:
NCT06664151
Condition:
Skin Cancer
Cutaneous Squamous Cell Carcinoma (CSCC)
Cutaneous Squamous Cell Cancer
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Skin Neoplasms
Neoplasms, Squamous Cell
Vaccines
Conditions: Keywords:
Skin Cancer
Cutaneous Squamous Cell Carcinoma
Cutaneous Squamous Cell Cancer
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Fluzone Trivalent
Description:
Inactivated influenza vaccine, 0.5mL single-dose, pre-filled syringe, via intratumoral
(into a tumor) injection per protocol.
Arm group label:
Fluzone Vaccine in Cutaneous Squamous Cell Carcinoma
Other name:
Influenza Vaccine
Other name:
Flu shot
Summary:
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)
Detailed description:
This Phase 0, window-of-opportunity 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. This
study will help understand if the addition of the influenza vaccine can improve the
immune system response against the cancer.
The research study procedures include screening for eligibility, in-clinic visits, blood
tests, and measurements and photographs of tumors.
It is expected that 25 people will take part in this research study.
Criteria for eligibility:
Criteria:
Inclusion 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.
Exclusion Criteria:
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Brigham and Women's Hospital
Address:
City:
Boston
Zip:
02215
Country:
United States
Contact:
Last name:
Karam Khaddour, MD
Phone:
617-632-6571
Email:
karam_khaddour@dfci.harvard.edu
Investigator:
Last name:
Karam Khaddour, MD
Email:
Principal Investigator
Facility:
Name:
Dana-Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Contact:
Last name:
Karam Khaddour, MD
Phone:
617-632-6571
Email:
karam_khaddour@dfci.harvard.edu
Investigator:
Last name:
Karam Khaddour, MD
Email:
Principal Investigator
Start date:
October 2024
Completion date:
August 30, 2025
Lead sponsor:
Agency:
Dana-Farber Cancer Institute
Agency class:
Other
Source:
Dana-Farber Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06664151
