Fenofibrate in Patients With Cervical Intraepithelial Neoplasia and Invasive Cervical Carcinoma

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Lindsay Ferguson, MD
Study ID
NCT06191133
Phase
PHASE1
Status
Recruiting
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Conditions

  • Cervical Intraepithelial Neoplasia
  • Invasive Cervical Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Nov 20, 2024
Status verified
Sep 2025
Primary completion
Jun 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
24 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Change in p53 levels [ Time Frame: Up to six weeks after study enrollment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer CenterClevelandOhio44106
Lindsay A Ferguson, MD
[email protected]
216-844-3954

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By research site
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center· Cleveland, OH

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