An Open-label, Biomarker Study of Arsenic Trioxide for the Treatment of Patients With Basal Cell Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Percent Change in Biomarker (GLI2 Protein) Levels
研究概览
简要总结
This pilot clinical trial studies arsenic trioxide in treating patients with basal cell carcinoma. Drugs used in chemotherapy, such as arsenic trioxide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stop them from dividing
详细描述
PRIMARY OBJECTIVES:
I. To determine whether administration of arsenic trioxide (ATO) to patients with basal cell carcinoma is associated with a reduction in Gli messenger ribonucleic acid (mRNA) and protein levels in tumor biopsy samples, when compared to baseline levels.
SECONDARY OBJECTIVES:
I. To determine whether there is evidence of tumor size reduction of ATO against basal cell carcinoma in humans.
OUTLINE:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Treatment (arsenic trioxide)
Patients receive arsenic trioxide IV over 2 hours on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: arsenic trioxide (Drug)
结局指标
主要结局
Percent Change in Biomarker (GLI2 Protein) Levels
时间窗: baseline to day 33
次要结局
- Patients With Stable Disease Post Treatment(After 3 cycles of treatment (approx. 61 days))
- Patients With Progressive Disease Post Treatment by RECIST Criteria(After 3 treatment cycles (approx. 61 days))
- Incidence of Grade 3/4 Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0(Baseline to cycle 3)
研究者
Jean Yuh Tang
Associate Professor of Dermatology
Stanford University