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临床试验/NL-OMON44907
NL-OMON44907已完成2 期

A comprehensive and targeted therapy approach in pediatric malignant pontine gliomas - DIPG study VUmc 01

Vrije Universiteit Medisch Centrum0 个研究点目标入组 9 人开始时间: 待定最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
9

研究概览

简要总结

Trial ended prematurely

研究设计

研究类型
Interventional

入排标准

年龄范围
2 至 17(—)

入选标准

  • Patients with newly diagnosed, unresectable grade II-IV pontine glioma.
  • - Age between 3 and 18 years
  • - Willingness to perform a pregnancy test in females of child bearing age
  • - Written informed consent
  • - Platelet count * 100 x10 9/L (transfusion independent)
  • - Peripheral absolute neutrophil count (ANC) * 1.0 x10 9/L
  • - Direct bilirubin * 1.5 x upper limit of normal (ULN) for age
  • - SGPT (ALAT) < 5 x upper limit of normal (ULN) for age.
  • - Adequate Renal Function Defined As:
  • - Serum creatinine * 1.5 x upper limit of normal (ULN) for age;Phase B: patients with progressive disease after radiotherapy

排除标准

  • - Pilocytic (grade 1) astrocytomas
  • - Cervicomedullary junction tumors
  • - Presence of diffuse leptomeningeal disease.
  • - Performance status (Lansky or Karnofsky score) of 40% or less
  • - Life expectancy of less than six weeks without further therapy
  • - Pregnant or breastfeeding
  • - Other contra-indications for chemotherapy
  • - Neurofibromatosis type I

研究者

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