EUCTR2005-000459-14-ES进行中（未招募）不适用
A Stratified Phase II Study of Cetuximab (ErbituxTM) for the Treatment of Recurrent Glioblastoma Multiforme / Estudio de fase II estratificado de cetuximab para el tratamiento del glioblastoma multiforme recidivante - Cetuximab for recurrent GBM
Oncologisch Centrum, Academisch Ziekenhuis Vrije Universiteit Brussel0 个研究点目标入组 54 人开始时间: 2007年7月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 54
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
- •1.Recurrent GBM (de novo or secondary) after previous treatment by neurosurgery,
- •radiotherapy and temozolomide chemotherapy.
- •2.Availability of pretreatment tumor tissue for IHC and FISH analysis of the EGF-
- •Receptor and gene.
- •3.Measurable disease on GdMRI of the brain.
- •4.Proven disease progression on sequential GdMRI prior to study entry.
- •5.Life expectancy of at least 3 months and WHO-PS > 2.
- •6.A stable dose of corticosteroids for at least 1 week before study entry.
- •7.Standard phase II exclusion criteria for cytotoxic drug studies and Cetuximab
- •8. Informative result from EGFR FISH analysis on pretreatment GBM tissue.
- •Are the trial subjects under 18? no
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Standard phase II exclusion criteria for cytotoxic drug studies and Cetuximab
研究者
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