Spots Global Cancer Trial Database for Prevention of Recurrence and Metastasis in Genetically High-Risk Melanomas
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Trial Identification
Brief Title: Prevention of Recurrence and Metastasis in Genetically High-Risk Melanomas
Official Title: Prevention of Recurrence and Metastasis in Genetically High-Risk Melanomas
Study ID: NCT04285749
Conditions
Study Description
Brief Summary: The purpose of this study is to determine whether a medication, fluvastatin, can change melanoma to a state that is less likely to metastasize or recur. Fluvastatin is experimental in this setting because it is not approved by the Food and Drug Administration (FDA) for treatment or prevention of melanoma. However, fluvastatin has been approved by the FDA for treating high cholesterol.
Detailed Description: This is an open-label, single arm, study assessing the activity of fluvastatin in shifting the transcriptome in melanoma. Subjects with melanoma will be asked to participate and all subjects will receive the study drug, fluvastatin, for 2 weeks. The primary objective of this study to determine whether administration of fluvastatin changes the melanoma transcriptome The secondary objective of this study is to determine whether administration of fluvastatin changes the gene expression profile of Class 2 melanoma to Class 1 melanoma.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Contact Details
Name: Wesley Yu, MD
Affiliation: University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Role: PRINCIPAL_INVESTIGATOR
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