Window of Opportunity Pilot Study of Topical Tranexamic Acid for Cutaneous Squamous Cell Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 32
- 主要终点
- Percentage of subjects who have a reduction in tumor size
研究概览
简要总结
Tranexamic Acid (TXA) is a safe and effective antifibrinolytic drug used systemically to control bleeding and topically to treat melasma and rosacea. TXA suppresses the viability of multiple human/murine cancer cell lines and Plasmin formation, which prevents cleavage of the CDCP1 protein to a more oncogenic form. TXA appears to act through additional anticancer mechanisms that include reduction of S6K1 and STAT3 phosphorylation on sites required for their activation.
Uptake by cancer results in blockade of protein synthesis, and alter signaling through the amino acid-sensitive mTORC1/S6K1 and GCN2/eiF2a/ATF4 pathways. This is expected to induce autophagy, which may mediate some of the biological effects of TXA on cells. This effect of TXA is expected to be most prominent in cells that rely on high levels of basal protein synthesis such as cancer cells. Currently no clinical treatment in this space to spare or improve surgical outcomes.
Positive results could help reduce tumor size and suppress new cancer cell production before surgical interventions are taken. This treatment could improve the outcomes and treatments of people with skin cancer. If this window study is successful further studies will focus on patients with unresectable disease or those with lesions in areas difficult for surgical intervention.
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
- •Adults ≥ 18 years of age.
- •A clinical diagnosis of squamous cell carcinoma confirmed pathologically through biopsy (shave, punch, or partial excision) consistent with Stage I or II cutaneous squamous cell carcinoma, including those but not limited to those with high-risk features by BWH staging criteria:
- •Depth/invasion: > 2 mm thickness (Breslow thickness), Clark level ≥ IV, Perineural invasion
- •Anatomic: Primary site ear
- •Location: Primary site hair-bearing lip
- •Differentiation: Poorly differentiated or undifferentiated
- •Ability to apply topical treatment 3 times per day and record event times in a journal
- •Use of other topical creams on affected areas
- •Cutaneous squamous cell carcinoma secondary to immunosuppression and/or HIV allowed
- •Subjects must not have more than one active malignancy at the time of enrollment (Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen [as determined by the treating physician or approved by the PI] may be included).
- •Written informed consent obtained from the subject and the subject agrees to comply with all the study-related procedures, such as ability to apply topical treatment 3 times per day and record times in a journal.
- •Subjects of childbearing potential (SOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for at least 1 week after the last application of study treatment to minimize the risk of pregnancy. Prior to study enrollment, subjects of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy.
排除标准
- •Allergy to TXA or any of its components
- •Active skin infection at or near the tumor site
- •Known stage III or IV disease
- •Disease without measurable surface area following biopsy
- •Subjects of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 1 week after the last application of study treatment.
- •Subjects who are confirmed to be pregnant or breastfeeding.
- •History of any other disease, metabolic dysfunction, clinical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician.
- •Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.
研究组 & 干预措施
Topical tranexamic acid
干预措施: Tranexamic acid (Drug)
结局指标
主要结局
Percentage of subjects who have a reduction in tumor size
时间窗: 35 days
Determine the percentage of subjects who have a reduction in tumor size at the time of definitive surgery, as compared to tumor size at baseline. This is measured by comparing the total tumor area before treatment with the total tumor area at the time of definitive surgery. Tumor area will be measured via images and will be calculated using length x width x height in mm.
次要结局
- Difference in surgical defect size and tumor area at the time of surgery(At the time of surgery)
- Maximal tumor reduction(35 days)
- Treatment compliance(21-28 days)
- Treatment tolerance(21-28 days)