Window of Opportunity Trial of Fenofibrate in Patients With High-grade Cervical Intraepithelial Neoplasia and Invasive Cervical Carcinoma
Lindsay Ferguson, MD
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * 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. Exclusion Criteria: * Par…
Interventions
- DrugFenofibrate
Fenofibrate is an FDA approved drug for cardiovascular indications and have decades of data supporting a favorable safety profile event with chronic use.
- ProcedureCervical Conization
Cold knife conization or loop electrosurgical excision to remove cells and tissue in the cervix
- ProcedureHysterectomy
In a hysterectomy, the uterus, cervix, both ovaries, both fallopian tubes, and nearby tissue are removed.
- RadiationChemoradiation
Chemotherapy uses anti cancer (cytotoxic) drugs to destroy cancer cells. The drugs circulate throughout the body in the bloodstream. Radiotherapy uses high energy waves similar to x-rays to kill cancer cells.
Location
- University Hospitals Cleveland Medical Center, Case Comprehensive Cancer CenterCleveland, Ohio