RecruitingPhase 1NCT06191133

Fenofibrate in Patients With Cervical Intraepithelial Neoplasia and Invasive Cervical Carcinoma

Window of Opportunity Trial of Fenofibrate in Patients With High-grade Cervical Intraepithelial Neoplasia and Invasive Cervical Carcinoma

Sponsor

Lindsay Ferguson, MD

Enrollment

24 participants

Start Date

Nov 20, 2024

Study Type

INTERVENTIONAL

Conditions

Cervical Intraepithelial Neoplasia Invasive Cervical Cancer

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

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria6

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 Criteria5

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.

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.