Using Fenofibrate to treat cervical cancer and dysplasia

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

This study is testing if Fenofibrate, a cholesterol-lowering drug, can help treat cervical cancer and pre-cancerous changes by trying to improve how cells work and slow down tumor growth.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Case Comprehensive Cancer Center (other)
• Locations: 1 site (Cleveland, Ohio)
• Trial ID: NCT06191133 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of Fenofibrate, a cholesterol-lowering medication, on patients with cervical intraepithelial neoplasia and invasive cervical carcinoma. Researchers aim to understand how Fenofibrate can restore normal p53 function and alter the metabolism of HPV-positive tumors to inhibit their growth. The study will involve examining tissue samples and analyzing various genes and proteins to assess the drug's impact on these conditions. Participants will undergo surgical management or chemoradiation as part of their treatment.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with confirmed high-grade cervical dysplasia or cancer who are eligible for surgical management or chemoradiation.

Not a fit: Patients with active liver disease, severe kidney impairment, or known hypersensitivity to Fenofibrate may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with HPV-positive cervical cancers and dysplasia.

How similar studies have performed: While the use of Fenofibrate in this context is novel, early studies suggest potential efficacy in restoring p53 function in HPV-positive tumors.

Eligibility criteria

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:

* 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.

Where this trial is running

Cleveland, Ohio

• University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center — Cleveland, Ohio, United States (RECRUITING)

Study contacts

• Principal investigator: Lindsay Ferguson, MD — University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
• Study coordinator: Lindsay A Ferguson, MD

Conditions: Cervical Intraepithelial Neoplasia, Invasive Cervical Cancer, Fenofibrate