Phase I Study of ET-743 in Pediatric Refractory Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 47
- 主要终点
- Progression Free Survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Ecteinascidin 743 may be an effective treatment for solid tumors.
PURPOSE: Phase I trial to study the effectiveness of ecteinascidin 743 in treating children who have refractory solid tumors.
详细描述
OBJECTIVES: I. Determine the maximum tolerated dose and dose-limiting toxicity of ecteinascidin 743 in pediatric patients with refractory solid tumors. II. Determine the pharmacokinetics of this drug in these patients. III. Determine the antitumor activity of this drug in this patient population.
OUTLINE: This is a dose escalation, multicenter study. Patients are stratified according to pretreatment (pretreated vs less heavily pretreated). Patients receive ecteinascidin 743 IV over 3 hours on day 1. Treatment continues every 3 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of ecteinascidin 743 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicities.
PROJECTED ACCRUAL: A total of 3-20 patients will be accrued for this study within 2 years.
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
- 1 Year 至 17 Years（Child）
- 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
Therapy ECTEINASCIDIN 743 (1100 ug/m2 )
干预措施: ECTEINASCIDIN 743 (Drug)
ECTEINASCIDIN 743 (1300 ug/m2)
干预措施: ECTEINASCIDIN 743 (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: Length of study
次要结局
- Dose Limiting Toxicity
- Determine a safe and tolerable dose of vincristine, when administered with irinotecan
- Determine the pharmacokinetics of vincristine and irinotecan(Length of study)
- Determine the incidence and severity of other toxicities(Length of study)
- Seek preliminary evidence of anti-tumor activity of irinotecan plus vincristine(Length of study)