A Phase I Study Evaluating the Efficacy and Safety of Sodium Selenite in Combination With Palliative Radiation Therapy in Patients With Metastatic Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Safety and tolerability of the combination using the NCI Common Toxicity Criteria v4.0 grading system for adverse events
研究概览
简要总结
The purpose of this study is to determine the maximum-tolerated dose (MTD) of sodium selenite when administered in combination with radiation therapy to subjects with metastatic cancer based on safety and tolerability.
详细描述
Primary Objectives:
- To determine the maximum tolerated dose (MTD) of sodium selenite when given in combination with palliative radiation therapy
- To assess the safety and tolerability of the combination of sodium selenite and palliative radiation therapy in metastatic cancer
Secondary Objectives:
- To assess the pharmacokinetics of sodium selenite
- To evaluate the anti tumor activity of sodium selenite and palliative radiation therapy when given in combination
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
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Treatment (sodium selenite and radiation therapy)
Patients receive sodium selenite PO 2 hours before daily radiation therapy treatments. Treatment continues for the duration of the course of radiation therapy in the absence of disease progression or unacceptable toxicity.
干预措施: radiation therapy (Radiation)
Treatment (sodium selenite and radiation therapy)
Patients receive sodium selenite PO 2 hours before daily radiation therapy treatments. Treatment continues for the duration of the course of radiation therapy in the absence of disease progression or unacceptable toxicity.
干预措施: sodium selenite (Drug)
Treatment (sodium selenite and radiation therapy)
Patients receive sodium selenite PO 2 hours before daily radiation therapy treatments. Treatment continues for the duration of the course of radiation therapy in the absence of disease progression or unacceptable toxicity.
干预措施: laboratory biomarker analysis (Other)
Treatment (sodium selenite and radiation therapy)
Patients receive sodium selenite PO 2 hours before daily radiation therapy treatments. Treatment continues for the duration of the course of radiation therapy in the absence of disease progression or unacceptable toxicity.
干预措施: pharmacological study (Other)
Treatment (sodium selenite and radiation therapy)
Patients receive sodium selenite PO 2 hours before daily radiation therapy treatments. Treatment continues for the duration of the course of radiation therapy in the absence of disease progression or unacceptable toxicity.
干预措施: questionnaire administration (Other)
结局指标
主要结局
Safety and tolerability of the combination using the NCI Common Toxicity Criteria v4.0 grading system for adverse events
时间窗: Up to 2 years
Safety observations and measurements including adverse events, laboratory data, vital signs, and performance status will be summarized.
MTD defined as the maximum dose at which =< 1 of 3 to 6 subjects in a dose group experience a drug-related dose-limiting toxicity, graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version (v)4.0
时间窗: 3 weeks
次要结局
- Pharmacokinetic (PK) profile(Week 1, day 1: at predose; 15 minutes; and at 1, 2, 4, and 24 hours; weeks 2 and 4, day 1: at predose and 1 hour)
- Overall biochemical response rate(Up to 11 weeks)
- Tumor responses within the radiation therapy field, assessed using Response Evaluation Criteria in Solid Tumors 1.1(Up to 2 years)
- Response rate (complete response, partial response and stable disease) within the radiation therapy field(Up to 2 years)