Cervical Intraepithelial Neoplasia, Invasive Cervical Cancer
Conditions
Keywords
Fenofibrate
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.
Interventions
DRUGFenofibrate
Fenofibrate is an FDA approved drug for cardiovascular indications and have decades of data supporting a favorable safety profile event with chronic use.
PROCEDURECervical Conization
Cold knife conization or loop electrosurgical excision to remove cells and tissue in the cervix
PROCEDUREHysterectomy
In a hysterectomy, the uterus, cervix, both ovaries, both fallopian tubes, and nearby tissue are removed.
RADIATIONChemoradiation
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.
Sponsors
Lindsay Ferguson, MD
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in p53 levels | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Fenofibrate tolerability | Up to six weeks after study enrollment | Assess tolerability of fenofibrate by comparing lab values at baseline to values at conclusion of treatment |
Countries
United States
Contacts
CONTACTLindsay A Ferguson, MD
PRINCIPAL_INVESTIGATORLindsay Ferguson, MD
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Outcome results
None listed