Disulfiram and Chelated Zinc for the Rx of Disseminated Mets Mel That Has Failed First Line Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 12
- 主要终点
- Overall Response Rate to Treatment of Melanoma With Disulfiram and Chelated Zinc
研究概览
简要总结
Primary Objectives Determine the response rate associated with treatment of refractory disseminated malignant melanoma with disulfiram and chelated zinc.
Secondary Objectives Determine the progression-free survival associated with treatment of refractory disseminated malignant melanoma with disulfiram and chelated zinc.
Determine the overall survival associated with treatment of refractory disseminated malignant melanoma with disulfiram and chelated zinc.
Determine the toxicity associated with treatment of refractory disseminated malignant melanoma with disulfiram and chelated zinc Determine the effect of disulfiram and chelated zinc on in vivo protein S-glutathionylation.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subjects must fulfill all the following inclusion criteria to be eligible for participation in the study, unless otherwise specified:
- •Male and female patients with stage IV melanoma cancer with biopsy proven metastases demonstrated by imaging studies. Extent of disease should be documented by CT scanning of the chest, abdomen and pelvis, or PET/CT scanning. At least one site of disease should be measurable by RECIST criteria.
- •Age of 18 years or more
- •ECOG performance status of 0 - 2
- •Patients must have received and progressed after or not responded to at least one cycle of first line therapy (chemotherapy, biotherapy, or biochemotherapy) or are unwilling or ineligible to undergo standard therapy
- •Patients with brain metastases along with disease at other sites are eligible to participate if their brain disease has been treated with surgery or radiation
- •Not currently receiving other cancer chemotherapy
- •Not currently participating in another study
- •Baseline AST and ALT not greater than 2.0 X upper limit of normal
- •Able and willing to provide informed consent and to comply with study procedures
- •Able to ingest oral medications
- •No known allergy to disulfiram or zinc gluconate
- •Willing to refrain from ingestion of alcoholic beverages while on the study
- •Serum copper within the normal range at baseline, or if outside the normal range, the PI will review for clinical significance
排除标准
- •Potential study subjects who meet any of the following criteria are not eligible for participation in the study:
- •Participation in another clinical trial of a therapeutic drug during the past 30 days
- •Addiction to alcohol or cocaine
- •Baseline AST or ALT greater than 2.0 X upper limit of normal
- •Unable to ingest oral medications
- •Unable to undergo CT scanning because of inability to lie recumbent in the scanner;
- •Actively receiving cytotoxic cancer chemotherapy agents
- •Evidence of thiuram allergy (may present as contact allergy to rubber or elastic)
- •Current use of sertraline and cyclosporine
- •Women of child-bearing potential who are not using a commonly accepted effective means of contraception; women of child-bearing potential will have a pregnancy test before enrollment
- •Need for warfarin or theophylline, the metabolism of which is likely influenced by disulfiram
- •Pregnant women and nursing mothers are not allowed to enroll on this study
- •Patients who are taking medications metabolized by cytochrome P450 2E1, including chlorzoxazone or halothane and its derivatives
研究组 & 干预措施
Disulfiram and chelated zinc
There is only one arm. All patients are treated wtih disulfiram and chelated zinc.
干预措施: disulfiram and chelated zinc (Drug)
结局指标
主要结局
Overall Response Rate to Treatment of Melanoma With Disulfiram and Chelated Zinc
时间窗: Response to treatment will be measured by RECIST evaluation at disease assessment time-points from date of randomization until the date of first documented progression or death from any cause whichever came first (up to 15 months.)
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT scanning of the chest, abdomen and pelvis, or PET/CT scanning.: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
次要结局
- Progression Free Survival(Every 56 days - for up to two years)