NCT01163487已完成1 期
Phase I Trial of Metabolic Reprogramming Therapy for Treatment of Recurrent Head and Neck Cancers
Daniel T. Chang1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2010年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- To determine the maximum tolerated dose of DCA in patients with recurrent head and neck cancer who have failed first-line therapy.
研究概览
简要总结
The purpose of this study is to study the effect of the drug DCA (dichloroacetate) on recurrent head and neck cancers. Part of this study will also use EF5 PET scan to study tumor hypoxia.
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
- •Pathologically confirmed head and neck squamous cell carcinoma
- •Age > 18 years old
- •Patients must have unresectable disease in which there is no accepted potentially curative treatment option
- •Patients must have acceptable organ and marrow function as defined below:
- •leukocytes >3,000/uL
- •absolute neutrophil count >1,500/uL
- •platelets >90,000/uL
- •total bilirubin <=1.5X normal institutional limits
- •AST(SGOT)/ALT(SGPT) <=2.5 X normal institutional limits with the following exceptions:
- •Patients with documented tumors involving the liver who have Grade <2 elevations in AST, ALT, and/or alkaline phosphatase are eligible if <5X ULN.
- •Patients with documented tumors involving bone who have a Grade <2 elevation in alkaline phosphatase are eligible if <5X ULN.
- •creatinine <=1.5X normal institutional limits OR creatinine clearance >50 mL/min on the basis of the Cockcroft-Gault glomerular filtration rate estimation
- •Patients must have non-cranial gross disease that is greater than 1 cm on CT scan prior to enrollment
- •Disease must be FDG-avid on PET scanning
- •Creatinine within normal institutional limits
- •Eastern Clinical Oncology Group performance status 0, 1 or 2 (Appendix 1)
- •Life expectancy > 12 weeks
- •Both men and women and members of all races and ethnic groups are eligible for this trial.
排除标准
- •Women who are pregnant
- •Administration of any systemic cytotoxic agents within the last 2 weeks of enrollment
- •Patients who are unwilling or unable to provide informed consent
- •Patients who have potentially curable disease
- •Participation in another concurrent treatment protocol
研究组 & 干预措施
Dichloroacetate (DCA)
Experimental
25 mg/kg/day, 37.5 mg/kg, or 50 mg/kg/day oral DCA.
干预措施: Dichloroacetate (Drug)
Dichloroacetate (DCA)
Experimental
25 mg/kg/day, 37.5 mg/kg, or 50 mg/kg/day oral DCA.
干预措施: EF5 (Device)
结局指标
主要结局
To determine the maximum tolerated dose of DCA in patients with recurrent head and neck cancer who have failed first-line therapy.
时间窗: Duration of study
次要结局
未报告次要终点
研究者
Daniel T. Chang
Assistant Professor of Radiation Oncology
Stanford University
研究点 (1)
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