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Atorvastatin for Preventing Disease Metastasis in Patients With Resected High-Risk Stage IIA, IIB, or IIIA Melanoma
Sponsor: OHSU Knight Cancer Institute
Summary
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.
Official title: A Decentralized Phase II Randomized Controlled Trial of Atorvastatin in Resected High-Risk Melanoma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2024-09-01
Completion Date
2029-09-01
Last Updated
2026-03-13
Healthy Volunteers
No
Conditions
Interventions
Atorvastatin
Given PO
Placebo Administration
Given orally (PO)
Computed Tomography
Undergo CT
Magnetic Resonance Imaging
Undergo MRI
Electronic Health Record Review
Ancillary studies
Locations (1)
OHSU Knight Cancer Institute
Portland, Oregon, United States