Study on Atorvastatin for Preventing Cancer Spread in Patients with High-Risk Stage IIA Melanoma

Sponsor: OHSU Knight Cancer Institute

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06157099

Provider View

This clinical trial is testing whether atorvastatin, a drug commonly used to lower cholesterol, can help prevent the spread of melanoma in patients who have had high-risk stage IIA melanoma surgically removed.

Patient Parameters

Program Overview

This study is exploring if atorvastatin can stop melanoma from spreading in patients who have had high-risk stage IIA melanoma removed. While most melanomas are caught early, about 10-15% can spread even after treatment. Once melanoma spreads, survival rates drop significantly. Atorvastatin, a drug used to lower cholesterol, might help prevent melanoma from spreading by stopping cancer cells from moving and sticking together, and by boosting the immune system. It may also block the formation of new pathways that cancer uses to spread. This study aims to see if atorvastatin can improve outcomes for these patients.

Description

The main goal of this study is to see if atorvastatin can help patients with high-risk melanoma live longer without the cancer coming back, compared to a placebo. Secondary goals include comparing how long patients live without the cancer spreading to other parts of the body, overall survival rates, and the usefulness of genetic testing in predicting melanoma behavior.

Participants will be randomly assigned to one of two groups:

  • Group 1: Will take a placebo pill once a day for up to 5 years, unless the cancer progresses or side effects become unacceptable. They will also have regular CT or MRI scans.
  • Group 2: Will take atorvastatin once a day for up to 5 years, under the same conditions as Group 1, and will also have regular scans.

After finishing the study treatment, participants will be monitored for another 5 years.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older, any gender or race.
  • Must have been diagnosed with stage IIA melanoma that has been completely removed by surgery.
  • Must not have had any other treatments for melanoma besides surgery.
  • Must start the study within 10 weeks of surgery, with some flexibility for delays.
  • Must show no signs of cancer spread on imaging tests.
  • Must be in good general health, with a performance status score of 2 or less.
  • Must have normal liver function and creatine kinase levels.
  • HIV-positive patients can participate if their viral load is undetectable.
  • Can have other cancers if they don't interfere with this study.
  • Women must not be pregnant or breastfeeding and must use effective birth control if they can become pregnant.

Exclusion Criteria

  • Cannot be taking any other experimental drugs.
  • Cannot have severe allergies to atorvastatin or similar drugs.
  • Cannot be currently taking or have taken statins in the past year.
  • Cannot be taking certain medications that interact with statins.
  • Cannot have any condition or history that might interfere with the study or not be in their best interest to participate.
  • Cannot have psychiatric or substance abuse issues that would prevent them from following the study requirements.

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