Prevention of Recurrence and Metastasis in Genetically High-Risk Melanomas
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 主要终点
- Genetic profile shift in melanoma transcriptome
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed melanoma clinically staged as AJCC Stage 1-
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Fluvastatin (Drug)
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.
干预措施: RNA-sequencing (Other)
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.
干预措施: Gene expression profiling (Other)
结局指标
主要结局
Genetic profile shift in melanoma transcriptome
时间窗: Two weeks
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
次要结局
- Number of patients who convert from Class 2 to Class 1(Two weeks)