Atorvastatin for Cancer

Overseen By KUCC Navigation

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Joaquina Baranda

Must not be taking: Investigational agents, Statins, Myopathy drugs

Disqualifiers: Pregnancy, Squamous cell cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 1-4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether atorvastatin, a medication commonly used to lower cholesterol, can reduce a specific protein (mutant p53) in certain types of cancer. The focus is on solid tumors and relapsed Acute Myeloid Leukemia (AML). Participants should have a confirmed malignant disease and plan to undergo surgery. Those who have had previous AML treatment and are between treatment regimens might also qualify. The trial aims to determine if taking atorvastatin for 1 to 4 weeks can make a difference before surgery. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to early-stage cancer research.

Will I have to stop taking my current medications?

The trial requires that you have not used systemic therapy like chemotherapy, immunotherapy, or hormonal therapy within the last 30 days. Also, you cannot use other investigational agents or statins in the past 30 days. If you're on these medications, you may need to stop them before joining the trial.

Is there any evidence suggesting that atorvastatin is likely to be safe for humans?

Research has shown that atorvastatin, a drug commonly used to lower cholesterol, is being studied for its potential effects on cancer. Studies indicate that atorvastatin is generally safe and well-tolerated. A large review found no connection between statin use and a higher cancer risk. In fact, another analysis found fewer new cancer cases and deaths among patients using statins compared to those who did not.

This trial is in an early stage, focusing on ensuring the treatment's safety for humans. Since atorvastatin is already approved for other uses, this provides some confidence about its safety. However, each study is unique, and this trial will help confirm its safety for this specific purpose. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Atorvastatin is unique because it's being explored as a cancer treatment, which is different from its usual role in managing cholesterol. Researchers are excited about atorvastatin because it may have anti-cancer properties, potentially interfering with cancer cell growth and survival. This is particularly intriguing since standard cancer treatments typically involve chemotherapy, radiation, or targeted therapies, which can have significant side effects. Atorvastatin could offer a novel approach with a potentially different side effect profile, making it a promising area of research in oncology.

What evidence suggests that atorvastatin might be an effective treatment for malignant diseases?

Research suggests that atorvastatin, a drug commonly used to lower cholesterol, might also aid in cancer treatment. Some studies have found that individuals taking statins, including atorvastatin, experienced fewer new cancer cases and deaths compared to those not taking these drugs. In this trial, participants will receive atorvastatin to assess its effects on cancer. Evidence from previous studies indicates that taking atorvastatin for two weeks before surgery can slow tumor growth in breast cancer patients. While these findings are encouraging, researchers continue to study atorvastatin's effectiveness in lowering mutant p53 protein levels in solid tumors and in cases of relapsed Acute Myeloid Leukemia (AML). Early research shows promise, but more information is needed to confirm its effects on these specific cancers. ^{2 4 6 7 8}

Who Is on the Research Team?

Joaquina Baranda, MD

Principal Investigator

The University of Kansas Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with various cancers, including solid tumors and blood cancers like relapsed AML, who are scheduled for surgery or between treatments. Participants must have TP53-positive or negative tumors, not be on recent cancer therapies, and have good organ function. Pregnant women can't join; neither can those with certain health conditions like active liver disease or a history of rhabdomyolysis.

Inclusion Criteria

A negative urine or serum pregnancy test within 7 days before Day 1 dose of study medication, if female participant is of childbearing potential.

I understand the study and can sign the consent myself.

My tumor is positive for the TP53 protein.

Exclusion Criteria

Hypersensitivity to atorvastatin or any component of the formulation

I had cancer before, but it's been in complete remission for over 2 years and I don't need treatment now.

I have been diagnosed with squamous cell cancer of the oropharynx.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive atorvastatin at a dose of 80 mg/day for 1 to 4 weeks

1-4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Atorvastatin

Trial Overview The trial tests if Atorvastatin (80 mg/day) taken for 1-4 weeks affects the levels of mutant p53 protein in malignant diseases. It's designed to see if this common cholesterol-lowering drug could help treat different types of cancer by targeting a specific protein involved in tumor growth.

How Is the Trial Designed?

Group I: Atorvastatin Experimental Treatment 1 Intervention

Atorvastatin 80 milligrams (mg) per day, orally for 1 - 4 weeks before surgery (surgery not part of clinical trial)

Atorvastatin is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Lipitor for:

• Hypercholesterolemia
• Mixed dyslipidemia
• Homozygous familial hypercholesterolemia

Approved in United States as Lipitor for:

• Hypercholesterolemia
• Mixed dyslipidemia
• Homozygous familial hypercholesterolemia
• Prevention of cardiovascular disease

Approved in Canada as Lipitor for:

• Hypercholesterolemia
• Mixed dyslipidemia
• Homozygous familial hypercholesterolemia
• Prevention of cardiovascular disease

Approved in Japan as Lipitor for:

• Hypercholesterolemia
• Mixed dyslipidemia
• Homozygous familial hypercholesterolemia

Approved in China as Lipitor for:

• Hypercholesterolemia
• Mixed dyslipidemia
• Homozygous familial hypercholesterolemia

Approved in Switzerland as Lipitor for:

• Hypercholesterolemia
• Mixed dyslipidemia
• Homozygous familial hypercholesterolemia

Who Is Running the Clinical Trial?

Joaquina Baranda

Lead Sponsor

Trials

1

Recruited

50+

Published Research Related to This Trial

In a study using rat models, atorvastatin and lovastatin did not significantly reduce the incidence of estrogen receptor-positive mammary cancers, indicating limited efficacy in cancer prevention.

While statins did not enhance the effectiveness of tamoxifen or bexarotene in reducing cancer multiplicity, they were able to lower triglyceride levels in bexarotene-treated rats, suggesting a potential role in managing lipid levels rather than directly preventing cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lack of efficacy of the statins atorvastatin and lovastatin in rodent mammary carcinogenesis. Lubet, RA., Boring, D., Steele, VE., et al.[2018]

Atorvastatin effectively reduced serum cholesterol levels in mice but did not decrease the size or number of chemically induced liver tumors, indicating it does not inhibit hepatocellular carcinoma (HCC) growth.

The study challenges the idea that long-term atorvastatin use may protect against HCC, as it showed no beneficial effects on tumor growth despite changes in drug uptake transporters in tumor tissue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chemically induced mouse liver tumors are resistant to treatment with atorvastatin. Braeuning, A., Bucher, P., Hofmann, U., et al.[2022]

Atorvastatin is a highly effective statin that significantly lowers LDL and total cholesterol levels, and it is the first statin proven to reduce triglycerides in patients with high triglyceride levels.

In addition to its cholesterol-lowering effects, atorvastatin has beneficial non-lipid effects, such as improving blood vessel function and reducing inflammation, although clinical trial evidence is still limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atorvastatin. Wierzbicki, AS.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10473877/

The effects of statins in patients with advanced-stage cancers Statin therapy has been shown to reduce mortality in a wide range of cancer types and overall stages. Still, there is uncertainty about its efficacy.

2. nature.com nature.com/articles/s41598-024-53252-4

Long-term use of anti-cholesterol drugs and cancer risks in ... A meta-analysis of data from 26 randomized controlled studies found no association between the use of statin and cancer incidence. However, the ...

3. lipidworld.biomedcentral.com lipidworld.biomedcentral.com/articles/10.1186/s12944-023-01955-4

The association of statin therapy and cancer: a meta-analysis According to their findings, the statin therapy group had fewer new cancer diagnoses and fewer cancer deaths than the control group. The trial ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10359995/

New insights into the therapeutic potentials of statins in ... Similarly, 2-week atorvastatin treatment before surgery decreased tumor cell proliferation in patients with primary invasive breast cancer (Feldt et al., 2015).

5. cancer.gov cancer.gov/news-events/cancer-currents-blog/2023/lymphoma-statin-reduces-chemo-heart-damage

Statin Protects Heart during Lymphoma Treatment - NCI A cholesterol-lowering drug may help reduce the risk of heart failure in people with lymphoma who receive chemotherapy drugs called anthracyclines.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2910322/

Statin Use and Cancer Risk: A Comprehensive Review [67] A large case-control study examining clinical outcomes in patients with already existing colorectal cancer found a 30% decreased odds in metastasis among ...

7. lipidworld.biomedcentral.com lipidworld.biomedcentral.com/counter/pdf/10.1186/s12944-023-01955-4.pdf?utm_source=consensus

The association of statin therapy and cancer: a meta-analysis According to their findings, the statin therapy group had fewer new cancer diagnoses and fewer cancer deaths than the con- trol group. The trial conducted in ...

8. fredhutch.org fredhutch.org/en/news/spotlight/2024/06/exploring-the-potential-of-statins-in-reducing-breast-cancer-mor.html

Exploring the potential of statins in reducing breast cancer ... Recent findings show how statins, commonly used for lowering cholesterol, may offer new hope in improving survival rates for breast cancer ...