RECRUITING

Atorvastatin for Preventing Disease Metastasis in Patients With Resected High-Risk Stage IIA, IIB, or IIIA Melanoma

Conditions

Clinical Stage IIA Cutaneous Melanoma AJCC v8 Clinical Stage IIB Cutaneous Melanoma AJCC v8 Pathologic Stage IIIA Cutaneous Melanoma AJCC v8

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2024-09-01

Study Completion:2029-09-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06157099

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Wesley Yu, M.D.

CONTACT

503-418-3376

yuwe@ohsu.edu

Principal Investigator

Wesley Yu, M.D.

PRINCIPAL_INVESTIGATOR

OHSU Knight Cancer Institute

Study Locations (Sites)

OHSU Knight Cancer Institute

Portland, Oregon, 97239

United States

Collaborators and Investigators

Sponsor: OHSU Knight Cancer Institute

Wesley Yu, M.D., PRINCIPAL_INVESTIGATOR, OHSU Knight Cancer Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-01

Study Completion Date2029-09-01

Study Record Updates

Study Start Date2024-09-01

Study Completion Date2029-09-01

Terms related to this study

Additional Relevant MeSH Terms

Clinical Stage IIA Cutaneous Melanoma AJCC v8
Clinical Stage IIB Cutaneous Melanoma AJCC v8
Pathologic Stage IIIA Cutaneous Melanoma AJCC v8