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Recruiting NCT06191133

Fenofibrate in Patients With Cervical Intraepithelial Neoplasia and Invasive Cervical Carcinoma

Phase I Interventional Cervical Intraepithelial Neoplasia Invasive Cervical Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Fenofibrate, Cervical Conization, Hysterectomy, Chemoradiation.
Who it may be relevant to
Registry conditions: Cervical Intraepithelial Neoplasia, Invasive Cervical Cancer. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Fenofibrate
    Fenofibrate is an FDA approved drug for cardiovascular indications and have decades of data supporting a favorable safety profile event with chronic use.
  • Procedure Cervical Conization
    Cold knife conization or loop electrosurgical excision to remove cells and tissue in the cervix
  • Procedure Hysterectomy
    In a hysterectomy, the uterus, cervix, both ovaries, both fallopian tubes, and nearby tissue are removed.
  • Radiation Chemoradiation
    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.

Primary outcome measures

  • Change in p53 levels [Time frame: Up to six weeks after study enrollment]
  • Change in tumor metabolic status [Time frame: Up to six weeks after study enrollment]
Secondary outcome measures (1)
  • Fenofibrate tolerability [Time frame: Up to six weeks after study enrollment]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center — Cleveland

Identifiers

NCT: NCT06191133 · CASE3822

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗