A Window of Opportunity Trial of Intratumoral Injection of Copaxone® in Patients With Percutaneously Accessible Tumors
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 10
- 试验地点
- 3
- 主要终点
- Proportion of participants that experience Treatment Related Adverse Events (TRAEs) or Treatment Related Serious Adverse Events (TRSAEs)
研究概览
简要总结
The investigator believes that injecting Copaxone into tumors will help participants immune system fight cancer. This has been studied in mice and has shown encouraging results. Copaxone is a safe medication currently used to treat Multiple Sclerosis (MS) and has very few side effects. To be considered for this trial a tumor must be easy to be injected and must be at least the size of a pea. Participants will be closely monitored for any side effects. Tissue from before surgery will be compared to tissue after the treatment and surgery to be checked for immune response and anti-tumor effects.
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
- •Ability of participant or Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent.
- •Have confirmed diagnosis of squamous cell cancer or cutaneous squamous cell cancer or basal cell carcinoma.
- •Have one or more tumors measuring at least 5 mm in diameter.
- •No prior therapy for this malignancy.
- •Women of child-bearing potential and men with partners of child-bearing potential must agree to practice sexual abstinence, or to use two forms of adequate contraception (hormonal AND barrier method of birth control) prior to study entry, for the duration of study participation until the end of study treatment. If a woman becomes pregnant or suspects she is pregnant while participating in this study, she should inform her treating physician immediately.
- •Men of child-bearing potential must not father a child or donate sperm while on this study until the end of study treatment.
- •Physician feels the patient is medically fit for the trial.
排除标准
- •Current or anticipated use of other investigational agents while participating in this study.
- •Pregnant or breast feeding. There is a potential for congenital abnormalities and for this regimen to harm breast feeding infants (if applicable) Planned treatment with chemotherapy and/or radiation therapy prior to standard of care surgery. Concurrent treatment with anti-cancer therapy is not allowed.
- •Hypersensitivity to Copaxone® or glatiramer acetate, mannitol, or any component of the formulation.
- •A known condition that leads to immunosuppression such as Acquired Immunodeficiency Syndrome (AIDS) or concurrent use of immunosuppressive therapy.
研究组 & 干预措施
Intratumoral Copaxone
Eligible subjects receive at least 1 and up to 3 doses of Copaxone® 40 milligrams (mg) intratumorally prior to standard of care surgery. The doses will be administered at least 48 hours apart. The last dose will be given within 96 hours of standard of care surgery.
干预措施: Copaxone (Drug)
结局指标
主要结局
Proportion of participants that experience Treatment Related Adverse Events (TRAEs) or Treatment Related Serious Adverse Events (TRSAEs)
时间窗: up to 6 weeks
Participants will be evaluated for TRAEs and TRSAEs from the time of the first injection (Day 1) through the time they go to surgery. TRAEs and TRSAEs will be evaluated per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
次要结局
- Immune Biomarker Level(Up to 6 weeks)