150 Participants Needed

Atorvastatin for Melanoma

WY
Overseen ByWesley Yu, M.D.
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 6 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Do I have to stop taking my current medications for the trial?

The trial requires that you stop taking any statins if you have been on them in the past year. Additionally, you cannot take cyclosporine, erythromycin, fibrates, niacin, or any other medication that is not compatible with statin treatment. For other medications, the protocol does not specify, so it's best to discuss with the trial team.

What data supports the effectiveness of the drug Atorvastatin for treating melanoma?

Research suggests that statins, like Atorvastatin, may have potential in preventing melanoma due to their lipid-lowering and anti-inflammatory effects. However, specific studies on Atorvastatin for melanoma are limited, and more research is needed to confirm its effectiveness.12345

Is atorvastatin generally safe for humans?

Atorvastatin, also known as Lipitor, is a medication commonly used to lower cholesterol and has been studied for its safety in humans. In clinical trials with similar drugs like lovastatin, no significant differences in adverse events were found compared to placebo, suggesting a good safety profile.12346

How does the drug Atorvastatin differ from other treatments for melanoma?

Atorvastatin, commonly used to lower cholesterol, is being explored for melanoma treatment, which is unique because it is not a standard cancer therapy like immune checkpoint inhibitors or BRAF-MEK inhibitors. This approach is novel as it investigates the potential of a cardiovascular drug in cancer treatment, possibly offering a new mechanism of action compared to existing melanoma therapies.7891011

What is the purpose of this trial?

This clinical trial tests whether atorvastatin prevents metastasis of resected high-risk stage IIA, IIB or IIIA melanoma. The vast majority of melanomas are diagnosed at an early, localized stage. However, approximately 10-15% of these localized melanomas will eventually metastasize, despite appropriate local treatment. Once metastasis occurs, median survival is less than two years. Melanomas at high risk of metastasis can be identified by gene expression profiling. Statin drugs, like atorvastatin, have been used to treat high cholesterol for the prevention of major adverse cardiovascular events, but not for preventing melanoma metastasis. Statins could prevent melanoma metastasis through decreasing tumor cell migration, decreasing tumor cell adhesion, and increasing immune system response. Statins are also efficient inhibitors of new lymphatic vessels formation. Since tumor lymphatic vessels serve as highways to lymph nodes and may suppress immune system responses, statins may block a critical step towards melanoma metastasis. Using atorvastatin may have the potential to prevent metastasis and improve outcomes in patients with resected high-risk melanoma.

Research Team

WY

Wesley Yu, M.D.

Principal Investigator

OHSU Knight Cancer Institute

Eligibility Criteria

This trial is for adults over 18 with a specific type of skin cancer called high-risk stage IIA cutaneous melanoma that's been surgically removed. They must not have had other melanoma treatments or certain medications, and should be generally healthy with no evidence of cancer spread. Women who can get pregnant must agree to use birth control.

Inclusion Criteria

My melanoma test result is class 2B.
My scans show no signs of cancer spread, and any suspicious areas have been tested and are not cancerous.
I can take care of myself but might not be able to do heavy physical work.
See 9 more

Exclusion Criteria

I am currently on a statin or was on one in the past year.
I am not taking medication that interferes with statin treatment.
Participant who in the opinion of the investigator, has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive atorvastatin or placebo orally once per day for up to 5 years, with regular CT and/or MRI scans to monitor disease progression

5 years

Follow-up

Participants are monitored for recurrence-free survival, distant metastasis-free survival, and overall survival after treatment completion

5 years

Treatment Details

Interventions

  • Atorvastatin
Trial Overview The study tests if atorvastatin, commonly used for cholesterol, can prevent the spread (metastasis) of resected high-risk melanoma by affecting tumor cell behavior and immune response. Participants will either receive atorvastatin or a placebo while being monitored through scans and health records.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm II (Atorvastatin)Experimental Treatment4 Interventions
Patients receive atorvastatin PO daily (QD) in the absence of disease progression or unacceptable toxicity for up to 5 years and undergo CT and/or undergo MRI throughout the study.
Group II: Arm I (Placebo)Placebo Group4 Interventions
Patients receive placebo PO daily (QD) in the absence of disease progression or unacceptable toxicity for up to 5 years and undergo CT and/or MRI throughout the study.

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

Find a Clinic Near You

Who Is Running the Clinical Trial?

OHSU Knight Cancer Institute

Lead Sponsor

Trials
239
Recruited
2,089,000+

Oregon Health and Science University

Collaborator

Trials
1,024
Recruited
7,420,000+

Kuni Foundation

Collaborator

Trials
3
Recruited
270+

Findings from Research

A systematic review of 16 randomized controlled trials involving 62,197 participants found that lipid-lowering medications (statins and fibrates) showed a 10% reduction in melanoma incidence for statins and a 42% reduction for fibrates, although these results were not statistically significant.
The study suggests that while there is some evidence that statins and fibrates may reduce melanoma risk, more research is needed to confirm these findings, and current best practice for melanoma prevention remains limiting UV exposure.
Statins and fibrates for preventing melanoma.Dellavalle, RP., Drake, A., Graber, M., et al.[2022]
In a study involving female B6D2F1 mice with melanoma, the combination of lovastatin and TNF-alpha significantly inhibited tumor growth and improved survival rates compared to control and single treatment groups.
The results suggest that lovastatin may enhance the antitumor effects of TNF-alpha, indicating a potential synergistic relationship that could be beneficial for cancer therapy.
Synergistic antitumor activity of tumor necrosis factor-alpha and lovastatin against MmB16 melanoma in mice.Feleszko, W., Lasek, W., Gołab, J., et al.[2013]
In a randomized, double-blind trial with 80 participants, lovastatin did not show any benefit in reducing melanoma-related biomarkers compared to placebo over a 6-month period.
While lovastatin effectively lowered total serum cholesterol and LDL levels, it did not impact the histopathologic atypia of atypical nevi or any other clinical or molecular markers related to melanoma risk.
A randomized, double-blind, placebo-controlled phase II clinical trial of lovastatin for various endpoints of melanoma pathobiology.Linden, KG., Leachman, SA., Zager, JS., et al.[2021]

References

Statins and fibrates for preventing melanoma. [2022]
Synergistic antitumor activity of tumor necrosis factor-alpha and lovastatin against MmB16 melanoma in mice. [2013]
A randomized, double-blind, placebo-controlled phase II clinical trial of lovastatin for various endpoints of melanoma pathobiology. [2021]
Autocrine secretion of 15d-PGJ2 mediates simvastatin-induced apoptotic burst in human metastatic melanoma cells. [2022]
Melanoma chemoprevention: a role for statins or fibrates? [2019]
Is statin use associated with a reduced incidence, a reduced Breslow thickness or delayed metastasis of melanoma of the skin? [2007]
Cardiovascular disease and malignant melanoma. [2023]
Cutaneous melanoma: Latest developments. [2020]
9.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[Melanoma: from molecular studies to the treatment breakthrough]. [2018]
Challenging resistance mechanisms to therapies for metastatic melanoma. [2022]
Anti-PD-1 and Novel Combinations in the Treatment of Melanoma-An Update. [2020]
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