NCT04285749

Prevention of Recurrence and Metastasis in Genetically High-Risk Melanomas

• Status: Withdrawn
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Malignant Melanoma

Interventions

Type	Name	Description
DRUG	Fluvastatin	Fluvastatin PO 80mg QD for 2 weeks
OTHER	RNA-sequencing	RNA-sequencing will be completed on the original diagnostic biopsy and the final melanoma excision
OTHER	Gene expression profiling	Gene expression profiling will be completed on the original diagnostic biopsy and the final melanoma excision

Timeline

• Start date: 2020-11-06
• Primary completion: 2021-04-01
• Completion: 2021-04-01
• First posted: 2020-02-26
• Last updated: 2020-07-27

Regulatory

• FDA-regulated drug study