Atorvastatin for Melanoma
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?
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
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
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
Follow-up
Participants are monitored for recurrence-free survival, distant metastasis-free survival, and overall survival after treatment completion
Treatment Details
Interventions
- Atorvastatin
Atorvastatin is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
- Hypercholesterolemia
- Mixed dyslipidemia
- Homozygous familial hypercholesterolemia
- Hypercholesterolemia
- Mixed dyslipidemia
- Homozygous familial hypercholesterolemia
- Prevention of cardiovascular disease
- Hypercholesterolemia
- Mixed dyslipidemia
- Homozygous familial hypercholesterolemia
- Prevention of cardiovascular disease
- Hypercholesterolemia
- Mixed dyslipidemia
- Homozygous familial hypercholesterolemia
- Hypercholesterolemia
- Mixed dyslipidemia
- Homozygous familial hypercholesterolemia
- Hypercholesterolemia
- Mixed dyslipidemia
- Homozygous familial hypercholesterolemia
Find a Clinic Near You
Who Is Running the Clinical Trial?
OHSU Knight Cancer Institute
Lead Sponsor
Oregon Health and Science University
Collaborator
Kuni Foundation
Collaborator