← Back to Search

HMG-CoA Reductase Inhibitor

Atorvastatin for Melanoma

Phase 2

Recruiting

Led By Wesley Yu, M.D.

Research Sponsored by OHSU Knight Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

DecisionDx Melanoma test result completed and resulted as class 2B

Participant must have no evidence of metastatic disease on imaging as determined by investigator assessment. All suspicious lesions amenable to biopsy should be confirmed negative for malignancy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomization to death due to any cause, assessed up to 5 years

Awards & highlights

Study Summary

This trial tests if atorvastatin can prevent metastasis of high-risk stage IIA melanoma, which can spread & reduce survival time. Statins may block a critical step towards melanoma metastasis & improve outcomes.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Atorvastatin may cause muscle pain, liver changes, digestive issues, and in rare cases severe allergic reactions. It might also affect pregnancy; hence women capable of childbearing need to use contraception during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My melanoma test result is class 2B.

Select...

My scans show no signs of cancer spread, and any suspicious areas have been tested and are not cancerous.

Select...

I can take care of myself but might not be able to do heavy physical work.

Select...

My liver tests, specifically ALT, are within normal limits.

Select...

I have only had surgery for my melanoma, with no prior radiation therapy.

Select...

My skin cancer was confirmed and fully removed; it was stage IIA.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization to death due to any cause, assessed up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomization to death due to any cause, assessed up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to death due to any cause, assessed up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Recurrence-free survival (RFS)

Secondary outcome measures

Distant metastasis-free survival (DMFS)

Overall survival (OS)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm II (Atorvastatin)Experimental Treatment4 Interventions

Patients receive atorvastatin PO once per day in the absence of disease progression or unacceptable toxicity for up to 5 years and undergo CT and/or MRI throughout the study.

Group II: Arm I (Placebo)Placebo Group4 Interventions

Patients receive placebo PO once per day in the absence of disease progression or unacceptable toxicity for up to 5 years and undergo CT and/or MRI throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Atorvastatin

1998

Completed Phase 4

~10900

Computed Tomography

2017

Completed Phase 2

~2720

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

OHSU Knight Cancer InstituteLead Sponsor

230 Previous Clinical Trials

2,090,576 Total Patients Enrolled

2 Trials studying Cutaneous Melanoma

180 Patients Enrolled for Cutaneous Melanoma

Oregon Health and Science UniversityOTHER

974 Previous Clinical Trials

7,385,762 Total Patients Enrolled

2 Trials studying Cutaneous Melanoma

180 Patients Enrolled for Cutaneous Melanoma

Kuni FoundationUNKNOWN

1 Previous Clinical Trials

110 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any more participants being accepted into this research study?

"The clinicaltrial.gov listing suggests that this particular trial is not actively enrolling volunteers, even though the webpage was last modified on November 27th 2023. Although this study does not need participants currently, there are 710 other research projects recruiting patients at the moment."

Answered by AI

To what extent can Arm II (Atorvastatin) be a hazard to individuals?

"Atorvastatin (Arm II) is deemed relatively safe, as it earned a score of 2 on the 1 to 3 safety scale. This rating comes from its Phase 2 status, which implies that there is some data attesting to its security but not enough evidence for efficacy yet."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Atorvastatin for Preventing Disease Metastasis in Patients With Resected High-Risk Stage IIA Melanoma

Wesley Yu, M.D. 2024. "Atorvastatin for Preventing Disease Metastasis in Patients With Resected High-Risk Stage IIA Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06157099.

All > Vancouver > Lipitor