A Phase 0 Window of Opportunity Trial of Intratumoral Seasonal Influenza Immunization in Cutaneous Squamous Cell Carcinoma (CSCC) Patients Awaiting Curative Excision
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Mean Percent Change of CD8+ T-cells Density
研究概览
简要总结
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)
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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
干预措施: Fluzone Trivalent (Biological)
结局指标
主要结局
Mean Percent Change of CD8+ T-cells Density
时间窗: Up to 15 Days
CD8+ T-cell infiltration density (as measured by cells/mm2) on tumors is collected at the time of Mohs micrographic surgery compared to baseline (time of diagnostic biopsy).
次要结局
- Change in Tumor Diameter(Up to 15 Days)
- Adverse Events(Up to 38 days)
- Mean Percent Change of Tumor Microenvironment Markers Compared Before and After Intratumoral Influenza Vaccination(Up to 15 Days)
研究者
Karam Khaddour
Principle Investigator
Dana-Farber Cancer Institute