Translational Phase I Trial of Escalating Doses of 5-Chloro-2'-Deoxycytidine (CldC) With a Fixed Dose of Tetrahydrouridine Combined With External Brain Radiation for Metastatic Carcinoma to the Brain
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- To establish a dose range of CldC for further clinical studies (Phase II clinical trials) based on safety and toxicity.
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs, such as cytochlor and tetrahydrouridine, may make tumor cells more sensitive to radiation therapy.
PURPOSE: This phase I trial is studying the side effects and best dose of cytochlor when given together with tetrahydrouridine and external-beam radiation therapy in treating patients with cancer that has spread to the brain.
详细描述
OBJECTIVES:
Primary
- Establish the safety and toxicity profile of cytochlor and H4U when given in combination with external-beam radiotherapy for 2 weeks after treatment with the drugs alone in the previous week.
Secondary
- Determine the effectiveness of H4U to inhibit systemic cytidine deaminase (CD) during the course of treatment with cytochlor and H4U.
- Perform detailed pharmacokinetic studies to determine the levels of cytochlor and its metabolites in serum and in urine in weeks 1, 2, and 3 during treatment.
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
- 21 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
CldC + H4U
干预措施: Cytochlor (Drug)
CldC + H4U
干预措施: Tetrahydrouridine (Drug)
CldC + H4U
干预措施: Radiation Therapy (Radiation)
结局指标
主要结局
To establish a dose range of CldC for further clinical studies (Phase II clinical trials) based on safety and toxicity.
时间窗: 2 Years
b) Establish the safety and toxicity profile of CldC+ H4U when given in combination with RT for 2 weeks following treatment with the drug alone for 3 days in the week prior to the combined treatment.
时间窗: Duration of study treatment
次要结局
- Cytochlor and metabolite levels in urine at weeks 1, 2, and 3(Pharmacokinetic sampling at protocol-specified timepoints during duration of treatment)
- a) Determine the effectiveness of H4U to inhibit systemic cytidine deaminase (CD) during the course of treatment with CldC + H4U.(At protocol specified timepoints during treatment)
- Cytochlor and metabolite levels in serum at weeks 1, 2, and 3(Pharmacokinetic sampling at protocol-specified timepoints during duration of treatment)
研究者
Brian Lally
Assistant Professor of Clinical
University of Miami