EUCTR2006-004982-32-AT进行中（未招募）不适用
Cerebrospinal fluid (CSF) and plasma pharmocokinetics of liposomal cytarabine (DepoCyte®) after intrathecal administration in children with malignant brain tumors and leptomeningeal dissemination
Medical University of Vienna, Department of Pedatrics0 个研究点开始时间: 2007年2月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Female or male, aged between 0 and 19 years (at time of first study dose)
- •Malignant brain tumor with leptomeningeal dissemination or risk of leptomeningeal dissemination, for whom no routine protocol is available (for example, AT/RT or Infantile malignant glioma)
- •Relapse of a brain tumor with leptomeningeal dissemination or risk of leptomeningeal dissemination of any histology
- •Treatment with intrathecal administered liposomal cytarabine for therapeutic reasons
- •Life expectancy of at least 8 weeks
- •Written informed consent of parents
- •Serum creatinine < 1.5 mg/L
- •Total serum bilirubin < 2.0 mg/dL and ALT less than 5 times upper limit of normal
- •Platelet count > 40.000/mm3 within 48 hours before first treatment
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years)
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Treatment with liposomal cytarabine not indicated
- •Evidence of obstructive hydrocephalus or compartmentalization of CSF flow
- •Severe uncontrolled infection
研究者
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