24 Participants Needed

Fenofibrate for Cervical Cancer

LA
Overseen ByLindsay A Ferguson, MD
Age: 18+
Sex: Female
Trial Phase: Phase 1
Sponsor: Lindsay Ferguson, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug fenofibrate for cervical cancer?

Research shows that fenofibrate can cause cancer cells, including cervical cancer cells, to die and stop growing by triggering a process called apoptosis (a type of programmed cell death) and halting the cell cycle. This suggests it might be effective against cervical cancer.12345

Is fenofibrate safe for use in humans?

Fenofibrate has been used for many years to lower cholesterol and triglycerides, and it is generally considered safe with a low frequency of side effects. Common side effects include stomach issues, muscle pain, skin problems, and dizziness. Long-term studies and extensive use in Europe and the US have shown it to be well-tolerated, with serious side effects being rare.12456

How does the drug fenofibrate work differently for cervical cancer compared to other treatments?

Fenofibrate is unique in treating cervical cancer because it works by inducing apoptosis (programmed cell death) and causing cell cycle arrest in cancer cells, which is different from traditional chemotherapy that often targets rapidly dividing cells more broadly.14789

What is the purpose of 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.

Research Team

LF

Lindsay Ferguson, MD

Principal Investigator

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Eligibility Criteria

This trial is for English-speaking adults over 18 with high-grade cervical dysplasia or cervical cancer (squamous cell, adenocarcinoma, adenosquamous carcinoma) who are being treated at University Hospital Seidman Cancer Center. They must be eligible for surgical management or chemoradiation and able to give informed consent.

Inclusion Criteria

I am eligible for surgery or chemoradiation as treatment.
I can understand and am willing to sign the consent form.
You are currently being treated at University Hospital Seidman Cancer Center.
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 200mg of Fenofibrate daily for 2-4 weeks until their excisional procedure or definitive hysterectomy/chemoradiation

2-4 weeks

Follow-up

Participants are monitored for changes in p53 levels and tumor metabolic status up to six weeks after study enrollment

6 weeks

Treatment Details

Interventions

  • Fenofibrate
Trial Overview Researchers are testing if Fenofibrate can treat HPV-positive cervical cancers and dysplasia by restoring p53 function and altering tumor metabolism. The study involves tissue sample analysis to observe the drug's effects on genes and proteins related to these conditions.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Hysterectomy or chemoradiation + fenofibrateExperimental Treatment3 Interventions
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
Group II: Excisional procedure + FenofibrateExperimental Treatment2 Interventions
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

Fenofibrate is already approved in United States, European Union, Canada for the following indications:

πŸ‡ΊπŸ‡Έ
Approved in United States as Fenofibrate for:
  • High cholesterol
  • Severe high triglycerides
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Approved in European Union as Fenofibrate for:
  • Mixed hyperlipidemia
  • Primary hypercholesterolemia
  • Severe hypertriglyceridemia
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Approved in Canada as Fenofibrate for:
  • Hyperlipidemia
  • Hypertriglyceridemia

Find a Clinic Near You

Who Is Running the Clinical Trial?

Lindsay Ferguson, MD

Lead Sponsor

Trials
1
Recruited
20+

Findings from Research

Fenofibrate was found to reduce the viability of HeLa cervical cancer cells in a dose-dependent manner, primarily through inducing cell cycle arrest in the G0-G1 phase and triggering caspase-dependent apoptosis.
The study also revealed that fenofibrate activated autophagy, which may help cancer cells survive; thus, combining fenofibrate with an autophagy inhibitor could enhance its anticancer effects against cervical cancer.
Fenofibrate Exerts Anticancer Effects on Human Cervical Cancer HeLa Cells via Caspase-Dependent Apoptosis and Cell Cycle Arrest.Song, SY., Lee, SY., Ko, YB., et al.[2022]
Fenofibrate significantly inhibits the growth of human ovarian cancer cells (SKOV3) in vitro, with a maximum inhibition rate of 72.41% after 72 hours of treatment at higher concentrations.
The drug also induces apoptosis in SKOV3 cells in a concentration-dependent manner and reduces cell migration, suggesting potential therapeutic effects against ovarian cancer, although the exact mechanisms require further investigation.
[Effects of fenofibrate on the growth and migration of ovarian cancer cells in vitro].Wang, H., He, CH., Bai, LP., et al.[2018]
Fenofibrate effectively induces apoptosis in mantle cell lymphoma (MCL) cells, reducing viable cell numbers by 50% at a concentration of approximately 20 microM over 72 hours, demonstrating its potential as a treatment option.
The mechanism of action involves the inhibition of the TNF-alpha/NF-kappaB signaling pathway, and since fenofibrate is already considered safe for human use, it could be a promising therapeutic strategy for patients with MCL.
Fenofibrate induces effective apoptosis in mantle cell lymphoma by inhibiting the TNFalpha/NF-kappaB signaling axis.Zak, Z., Gelebart, P., Lai, R.[2013]

References

Fenofibrate Exerts Anticancer Effects on Human Cervical Cancer HeLa Cells via Caspase-Dependent Apoptosis and Cell Cycle Arrest. [2022]
[Effects of fenofibrate on the growth and migration of ovarian cancer cells in vitro]. [2018]
Fenofibrate induces effective apoptosis in mantle cell lymphoma by inhibiting the TNFalpha/NF-kappaB signaling axis. [2013]
Fenofibrate induces apoptosis of triple-negative breast cancer cells via activation of NF-ΞΊB pathway. [2022]
Anticancer Properties of Fenofibrate: A Repurposing Use. [2022]
Safety of fenofibrate--US and worldwide experience. [2018]
Fenofibrate treatment is associated with better glycemic control and lower serum leptin and insulin levels in type 2 diabetic patients with hypertriglyceridemia. [2022]
Protective role of lipanthyl in women taking oral contraceptives. [2013]
[Pharmacology of fenofibrate (author's transl)]. [2013]
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