Prevention of Recurrence and Metastasis in Genetically High-Risk Melanomas

Malignant Melanoma Clinical Trial

Official title:

Prevention of Recurrence and Metastasis in Genetically High-Risk Melanomas

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04285749
• Other study ID #: CASE4619
• Status: Withdrawn
• Phase: Early Phase 1
• Start date: November 6, 2020
• Est. completion date: April 1, 2021

Study information

• Verified date: July 2020
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 1, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Malignant Melanoma
• Melanoma
• Recurrence

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Genetic profile shift in melanoma transcriptome	The study team will report which of the 28 genes had significant expression changes. A 2-fold change in the appropriate direction with a p-value of at least 0.05 will be considered significant for potential therapeutic value. P-values will be corrected for the false discovery rate using the Benjamini-Hochberg procedure. Fluvastatin successful in shifting the genetic profile in a therapeutic manner if at least half of the 28 genes have significant expression changes	Two weeks
Secondary	Number of patients who convert from Class 2 to Class 1	Number of patients who convert from Class 2 to Class 1 profile on retesting	Two weeks