EUCTR2009-016080-11-NL进行中（未招募）不适用
A COMPREHENSIVE AND TARGETED THERAPY APPROACH IN PEDIATRIC MALIGNANT PONTINE GLIOMAS - Comprehensive and multitargeted therapy for malignant pontine gliomas
VU University Medical Center0 个研究点开始时间: 2010年6月9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
- •-Patients with newly diagnosed DIPG
- •-Patients with newly diagnosed, unresectable grade II-IV pontine glioma.
- •-Age between 3 years and 18 years
- •-Willingness to perform a pregnancy test in females of child bearing age
- •-Written informed consent
- •Laboratory findings:
- •-Platelet count = 100 x109/L (transfusion independent)
- •-Peripheral absolute neutrophil count (ANC) = 1.0 x109/L
- •-Adequate Liver Function defined as:
- •oDirect bilirubin = 1.5 x upper limit of normal (ULN) for age
- •oSGPT (ALAT) < 5 x upper limit of normal (ULN) for age.
- •-Adequate Renal Function Defined As:
- •oSerum creatinine = 1.5 x upper limit of normal (ULN) for age.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Pilocytic (grade 1) astrocytomas
- •-Presence of diffuse leptomeningeal disease.
- •-Patients having been pre-treated for DIPG
- •-Performance status (Lansky or Karnofsky score) of 50% or less
- •-Pregnant or breastfeeding
- •-Other contra-indications for chemotherapy
- •-Neurofibromatosis type I, because of the much better prognosis of this patient group.
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