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

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug, Radiation
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Ohio
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
RECRUITING
Cleveland
Contact Information
Primary
Lindsay A Ferguson, MD
lindsay.ferguson@uhhospitals.org
216-844-3954
Time Frame
Start Date: 2024-11-20
Estimated Completion Date: 2026-11-30
Participants
Target number of participants: 24
Treatments
Experimental: 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
Experimental: 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
Sponsors
Leads: Lindsay Ferguson, MD

This content was sourced from clinicaltrials.gov