Fenofibrate in Patients With Cervical Intraepithelial Neoplasia and Invasive Cervical Carcinoma

Cervical Intraepithelial Neoplasia Clinical Trial

Official title:

Window of Opportunity Trial of Fenofibrate in Patients With High-grade Cervical Intraepithelial Neoplasia and Invasive Cervical Carcinoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06191133
• Other study ID #: CASE3822
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: August 1, 2024
• Est. completion date: May 31, 2025

Study information

• Verified date: April 2024
• Source: Case Comprehensive Cancer Center
• Contact: Lindsay A Ferguson, MD
• Phone: 216-844-3954
• Email: lindsay.ferguson[@]uhhospitals.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: May 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects must have histologically or cytologic confirmed high grade dysplasia or cervical cancer. Histologic types include squamous cell, adenocarcinoma or adenosquamous cell carcinoma.
• Subjects must be eligible for surgical management with LEEP, CKC or hysterectomy or chemoradiation
• Subjects receiving treatment at University Hospital Seidman Cancer Center
• Age = 18 years
• Subjects must be English speaking
• Subjects must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

• Subjects with a history of hepatic or renal insufficiency
• Subjects that are pregnant or breast feeding because of potential due to unknown risk to developing fetus/infant. Please note: Patients are actively screened for pregnancy prior to diagnostic cervical colposcopy procedures and screened again prior to treatment of surgical pathology.

Related Conditions & MeSH terms

• Carcinoma in Situ
• Cervical Intraepithelial Neoplasia
• Neoplasms
• Uterine Cervical Dysplasia

Intervention

Drug:
• Fenofibrate
Fenofibrate is an FDA approved drug for cardiovascular indications and have decades of data supporting a favorable safety profile event with chronic use.

Procedure:
• Cervical Conization
Cold knife conization or loop electrosurgical excision to remove cells and tissue in the cervix
• Hysterectomy
In a hysterectomy, the uterus, cervix, both ovaries, both fallopian tubes, and nearby tissue are removed.

Radiation:
• Chemoradiation
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Lindsay Ferguson, MD

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in p53 levels	Changes in p53 levels from initial biopsy to repeat sampling at the time of surgery	Up to six weeks after study enrollment
Primary	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	Up to six weeks after study enrollment
Secondary	Fenofibrate tolerability	Assess tolerability of fenofibrate by comparing lab values at baseline to values at conclusion of treatment	Up to six weeks after study enrollment