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Prevention of Recurrence and Metastasis in Genetically High-Risk Melanomas

NCT04285749 · Status: WITHDRAWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL

Last updated 2020-07-27

No results posted yet for this study

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.

Conditions

  • Malignant Melanoma

Interventions

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

Sponsors & Collaborators

  • Case Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Wesley Yu, MD · University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-06
Primary Completion
2021-04-01
Completion
2021-04-01
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04285749 on ClinicalTrials.gov