Fenofibrate in Patients With Cervical Intraepithelial Neoplasia and Invasive Cervical Carcinoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18+
SponsorLindsay Ferguson, MD
About this trial
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 criteria
Qualifiers
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).
Disqualifiers
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
Trial design
Treatments tested in this trial
- Fenofibrate
- Cervical Conization
- Hysterectomy
- Chemoradiation
Treatment groups
24 Participants
are divided into 2 treatment groupsSponsors and collaborators
Lindsay Ferguson, MD
Lead sponsor
Case Comprehensive Cancer Center
Sponsor institution
Source ClinicalTrials.gov