Using atorvastatin to prevent melanoma from spreading in high-risk patients
A Decentralized Phase II Randomized Controlled Trial of Atorvastatin in Resected High-Risk Melanoma
This study is testing if the cholesterol-lowering drug atorvastatin can help prevent melanoma from spreading in patients who are at high risk after surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | OHSU Knight Cancer Institute Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Portland, Oregon) |
| Trial ID | NCT06157099 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of atorvastatin in preventing metastasis in patients with resected high-risk stage IIA, IIB, or IIIA melanoma. Participants are randomly assigned to receive either atorvastatin or a placebo for up to five years, with regular imaging to monitor disease progression. The primary goal is to compare recurrence-free survival between the two groups, while secondary objectives include assessing distant metastasis-free survival and overall survival. Additionally, the study explores the clinical utility of gene expression profiling in melanoma management.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with completely resected high-risk stage IIA, IIB, or IIIA cutaneous melanoma.
Not a fit: Patients who have received prior treatment for melanoma or those with unresected disease will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of melanoma metastasis and improve survival rates for high-risk patients.
How similar studies have performed: While statins have been primarily used for cardiovascular issues, there is emerging interest in their potential role in cancer treatment, though this specific application remains novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \>= 18 years. Both men and women and members of all races and ethnic groups are eligible for inclusion * Participants must have a diagnosis of American Joint Committee on Cancer (AJCC 8th) edition pathological stage IIA, IIB, or IIIA cutaneous melanoma that has been histologically confirmed and completely resected * Participants must not have been previously treated for melanoma beyond complete surgical resection. Participants must not have been treated with radiation therapy for their melanoma before study entry * No more than 10 weeks may elapse between final surgical resection and randomization. If there is a delay of 1 to 7 days exceeding 10 weeks due to unforeseen circumstances, the eligibility should be discussed with the principal investigator (at OHSU coordinating center) and the decision documented. A delay of 1 to 7 days for screening imaging requirements will be allowed if sponsor has allowed a 1-week extension between surgical resection and randomization * 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 * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 50%) * Liver function normal as defined by: Alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase (\[SGPT\]) =\< 2.5 × laboratory defined upper limit of normal * Creatine kinase (CK) =\< 3 × laboratory defined upper limit of normal * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with an undetectable viral load within 6 months prior to consent are eligible for this trial * Participant with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial * A participant is eligible to participate if they are not pregnant or breastfeeding, AND at least one of the following is true: Is not a person of childbearing potential (WOCBP); OR Is a WOCBP and agrees to use adequate contraception (hormonal or barrier method of birth control; abstinence) before study entry, and for the duration of study participation * The effects of atorvastatin on the developing human fetus are still under investigation. Animal data and retrospective human data suggest that statins may adversely affect pregnancy, thus WOCBP must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) before study entry, and for the duration of study participation. Should a participant become pregnant or suspect a pregnancy while participating in this study, the individual should inform their treating physician immediately Exclusion Criteria: * Participants who are receiving any other investigational agents * Participant who has a history of severe hypersensitivity (\>= grade 3) attributed to compounds of similar chemical or biologic composition to atorvastatin or other agents used in the study * Participants who are currently taking a statin or have taken a statin in the year before enrollment * Patients currently taking cyclosporine, erythromycin, fibrates, niacin, or any other medication that is contraindicated with statin treatment in the view of the investigator * 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 * Participant who has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
Where this trial is running
Portland, Oregon
- OHSU Knight Cancer Institute — Portland, Oregon, United States (Recruiting)
Study contacts
- Principal investigator: Wesley Yu, M.D. — OHSU Knight Cancer Institute
- Study coordinator: Wesley Yu, M.D.
- Email: yuwe@ohsu.edu
- Phone: 503-418-3376
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.