Clinical trial NCT06191133: Fenofibrate in Patients With Cervical Intraepithelial Neoplasia and Invasive Cervical Carcinoma
Official title: Window of Opportunity Trial of Fenofibrate in Patients With High-grade Cervical Intraepithelial Neoplasia and Invasive Cervical Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Cervical Intraepithelial Neoplasia
Invasive Cervical Cancer
Keywords: Fenofibrate
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Primary outcomes:
measure: Change in p53 levels
timeFrame: Up to six weeks after study enrollment
measure: Change in tumor metabolic status
timeFrame: Up to six weeks after study enrollment
Secondary outcomes:
measure: Fenofibrate tolerability
timeFrame: Up to six weeks after study enrollment
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
name: Lindsay Ferguson, MD
role: PRINCIPAL_INVESTIGATOR
References: