Window of Opportunity Trial of Fenofibrate in Patients With High-grade Cervical Intraepithelial Neoplasia and Invasive Cervical Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Change in p53 levels
研究概览
简要总结
Normally, p53 helps prevent tumors from forming in the body. Early studies have shown that Fenofibrate, a cholesterol-lowering drug, can restore normal function to p53 and can change the metabolism of HPV-positive tumors in a way that stops the growth of tumors. The purpose of this study is to understand how Fenofibrate can be used to treat HPV-positive cervical cancers and cervical dysplasia. Researchers will examine collected tissue samples and investigate various genes and proteins to see whether Fenofibrate has an effect on HPV-positive cervical cancers and cervical dysplasia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participants must have histologically or cytologic confirmed high grade dysplasia or cervical cancer. Histologic types include squamous cell, adenocarcinoma or adenosquamous cell carcinoma.
- •Participants must be eligible for surgical management with LEEP, CKC or hysterectomy or chemoradiation
- •Age ≥ 18 years
- •Normal liver function (AST, ALT, bilirubin within institutional normal limits).
- •Participants must be English speaking
- •Participants must have the ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Participants with active liver disease, including primary biliary cirrhosis and unexplained, liver function abnormality
- •Participants with severe kidney impairment (CrCl ≤30 mL/min calculated using Cockcroft-Gault), or end-stage kidney disease on dialysis
- •Participants with preexisting gallbladder disease including active gallstones
- •Known hypersensitivity to fenofibrate or fenofibric acid
- •Participants that are pregnant or breast feeding due to unknown risk to developing fetus/infant. Please note: Participants of child-bearing potential (have had menses within the past year or have not had total hysterectomy) are actively screened for pregnancy prior to diagnostic procedures and screened again prior to treatment.
研究组 & 干预措施
Excisional procedure + Fenofibrate
Participants with high-grade dysplasia will receive 200mg of Fenofibrate starting on the day of enrollment and will continue the drug administration daily for 2-4 weeks +/- 7 days until their excisional procedure
干预措施: Fenofibrate (Drug)
Hysterectomy or chemoradiation + fenofibrate
Participants with invasive cervical cancer will receive 200mg of Fenofibrate starting on the day of enrollment and will continue the drug administration daily for 2-4 weeks +/- 7 days until their definitive hysterectomy or chemoradiation
干预措施: Fenofibrate (Drug)
Excisional procedure + Fenofibrate
Participants with high-grade dysplasia will receive 200mg of Fenofibrate starting on the day of enrollment and will continue the drug administration daily for 2-4 weeks +/- 7 days until their excisional procedure
干预措施: Cervical Conization (Procedure)
Hysterectomy or chemoradiation + fenofibrate
Participants with invasive cervical cancer will receive 200mg of Fenofibrate starting on the day of enrollment and will continue the drug administration daily for 2-4 weeks +/- 7 days until their definitive hysterectomy or chemoradiation
干预措施: Hysterectomy (Procedure)
Hysterectomy or chemoradiation + fenofibrate
Participants with invasive cervical cancer will receive 200mg of Fenofibrate starting on the day of enrollment and will continue the drug administration daily for 2-4 weeks +/- 7 days until their definitive hysterectomy or chemoradiation
干预措施: Chemoradiation (Radiation)
结局指标
主要结局
Change in p53 levels
时间窗: Up to six weeks after study enrollment
Changes in p53 levels from initial biopsy to repeat sampling at the time of surgery
Change in tumor metabolic status
时间窗: Up to six weeks after study enrollment
Changes in tumor metabolic status from initial biopsy to repeat sampling at the time of surgery evaluated via immunohistochemical testing
次要结局
- Fenofibrate tolerability(Up to six weeks after study enrollment)
研究者
Lindsay Ferguson, MD
Principal Investigator
Case Comprehensive Cancer Center