Window of Opportunity Trial of Fenofibrate in Patients With High-grade Cervical Intraepithelial Neoplasia and Invasive Cervical Carcinoma
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 24
- Locations
- 2
- Primary Endpoint
- Change in p53 levels
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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
Intervention: Cervical Conization (Procedure)
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
Intervention: Hysterectomy (Procedure)
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
Intervention: Chemoradiation (Radiation)
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
Intervention: Fenofibrate (Drug)
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
Intervention: Fenofibrate (Drug)
Outcomes
Primary Outcomes
Change in p53 levels
Time Frame: Up to six weeks after study enrollment
Changes in p53 levels from initial biopsy to repeat sampling at the time of surgery
Change in tumor metabolic status
Time Frame: Up to six weeks after study enrollment
Changes in tumor metabolic status from initial biopsy to repeat sampling at the time of surgery evaluated via immunohistochemical testing
Secondary Outcomes
- Fenofibrate tolerability(Up to six weeks after study enrollment)
Investigators
Lindsay Ferguson, MD
Principal Investigator
Case Comprehensive Cancer Center