A Phase I Study of Temozolomide, Oral Irinotecan, and Vincristine for Children With Refractory Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 18
- 主要终点
- Determine maximum tolerated dose (MTD) of oral irinotecan
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as temozolomide, vincristine, and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of irinotecan when given together with temozolomide and vincristine in treating young patients with refractory solid tumors.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose and recommended phase II dose of irinotecan when administered with temozolomide and vincristine in young patients with refractory solid tumors, including brain tumors.
- Determine the toxic effects of this regimen in these patients.
- Compare the toxic effects of this regimen in patients with low- vs high-risk UGT1A1 genotypes.
- Determine the pharmacokinetics of irinotecan in these patients.
Secondary
- Determine, preliminarily, the antitumor activity of this regimen in these patients.
- Correlate UGT1A1, UGT1A7, UGT1A9, and BCRP genotypes with the pharmacokinetics and pharmacodynamics of irinotecan and its metabolites in these patients.
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 21 Years（Child, 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
Oral Irinotecan, temozolomide and vincristine sulfate
see detailed description
干预措施: irinotecan hydrochloride (Drug)
Oral Irinotecan, temozolomide and vincristine sulfate
see detailed description
干预措施: temozolomide (Drug)
Oral Irinotecan, temozolomide and vincristine sulfate
see detailed description
干预措施: vincristine sulfate (Drug)
结局指标
主要结局
Determine maximum tolerated dose (MTD) of oral irinotecan
时间窗: length of study
To estimate the maximum tolerated dose (MTD) of oral irinotecan administered on two different schedules together with fixed-dose temozolomide and vincristine in children with refractory solid tumors or brain tumors
次要结局
- To preliminarily define the antitumor activity(Length of study)