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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Fenofibrate is an FDA approved drug for cardiovascular indications and have decades of data supporting a favorable safety profile event with chronic use.
Cold knife conization or loop electrosurgical excision to remove cells and tissue in the cervix
In a hysterectomy, the uterus, cervix, both ovaries, both fallopian tubes, and nearby tissue are removed.
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.
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
RECRUITINGChange 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
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
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
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