Prevention of Recurrence and Metastasis in Genetically High-Risk Melanomas

NCT ID: NCT04285749

Last Updated: 2020-07-27

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: EARLY_PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-06
• Study Completion Date: 2021-04-01

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.

Conditions

Malignant Melanoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fluvastatin

Participants will receive Fluvastatin for 2 weeks.

RNA-sequencing and gene expression profiling will be completed on the original diagnostic biopsy and the final melanoma excision.

Group Type: EXPERIMENTAL

Fluvastatin

Intervention Type: DRUG

Fluvastatin PO 80mg QD for 2 weeks

RNA-sequencing

Intervention Type: OTHER

RNA-sequencing will be completed on the original diagnostic biopsy and the final melanoma excision

Gene expression profiling

Intervention Type: OTHER

Gene expression profiling will be completed on the original diagnostic biopsy and the final melanoma excision

Interventions

Fluvastatin

Fluvastatin PO 80mg QD for 2 weeks

Intervention Type: DRUG

RNA-sequencing

RNA-sequencing will be completed on the original diagnostic biopsy and the final melanoma excision

Intervention Type: OTHER

Gene expression profiling

Gene expression profiling will be completed on the original diagnostic biopsy and the final melanoma excision

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Histologically or cytologically confirmed melanoma clinically staged as AJCC Stage 1-3.
• Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

• Participant having received a statin drug within 1 month of study enrollment.
• Participant receiving any other investigational agents.
• History of adverse reactions (eg. myalgias, transaminitis, or rhabdomyolysis) attributed to compounds of similar chemical or biologic composition to fluvastatin or other agents used in this study.
• Participants with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, liver disease, or psychiatric illness/social situations that would limit compliance with study requirements.
• Participant currently pregnant (as assessed by positive pregnancy test prior to enrollment) or breastfeeding

--Pregnant or breastfeeding women are excluded from this study because Fluvastatin has the potential for teratogenic or abortifacient effects. Women of childbearing potential will be asked to take a pregnancy test prior to enrollment (unless a pregnancy test administered within the last month is present in the medical record and is negative). A woman of childbearing potential is defined as a premenopausal female capable of becoming pregnant. Men do not need to use contraception while taking this medication.

• Participants currently receiving BRAF inhibitors, MEK inhibitors, immunotherapy, or any other non-surgical treatment for melanoma.
• Participants currently receiving nucleoside reverse transcriptase inhibitors. These participants are excluded because use of NRTIs may confound the transcriptome measurements used in this study since as described above they are predicted to modify melanoma gene expression.
• Any condition or situation that, in the investigator's opinion, may put the patient at significant risk, or may significantly interfere with the patient's participation in the study.
• Participants concurrently taking macrolide antibiotics (eg erythromycin, clarithromycin), azole antifungals (eg itraconazole, ketoconazole), protease inhibitors (eg ritonavir, telaprevir), gemfibrozil, cyclosporine, danazol, amiodarone, amlodipine, verapamil, diltiazem, azithromycin, carbamazepine, phenytoin, or rifampin are excluded.
• Participants with baseline ALT greater than 3 times the upper limit of normal.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wesley Yu, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Other Identifiers

CASE4619

Identifier Type: -

Identifier Source: org_study_id