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Fenofibrate in Patients With Cervical Intraepithelial Neoplasia and Invasive Cervical Carcinoma

ConditionsCervical Intraepithelial NeoplasiaInvasive Cervical Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18+
SponsorLindsay Ferguson, MD

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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/Surgery

    Cold knife conization or loop electrosurgical excision to remove cells and tissue in the cervix

  • Hysterectomy

    Procedure/Surgery

    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.

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: Excisional procedure + FenofibrateExperimental treatment 2 interventions
Group B: Hysterectomy or chemoradiation + fenofibrateExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Change in p53 levels

Changes in p53 levels from initial biopsy to repeat sampling at the time of surgery

Time frame
Up to six weeks after study enrollment
2

Change in tumor metabolic status

Changes in tumor metabolic status from initial biopsy to repeat sampling at the time of surgery evaluated via immunohistochemical testing

Time frame
Up to six weeks after study enrollment

Secondary outcomes

1

Fenofibrate tolerability

Assess tolerability of fenofibrate by comparing lab values at baseline to values at conclusion of treatment

Time frame
Up to six weeks after study enrollment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Lindsay Ferguson, MD

Lead sponsor

Case Comprehensive Cancer Center

Sponsor institution

Source ClinicalTrials.gov
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