JPRN-UMIN000025033已完成2 期
Phase II study of Convection-enhanced delivery of Nimustine Hydrochloride combined with systemic Temozolomide against recurrent gliomas at brainstem - ACNU/CED plus systemic TMZ against recurrent gliomas at brainstem: Phase II study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- ot applicable 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1) Co-existence of uncured cancer. 2) Co-existence of meningitis or pneumonia that require treatment. 3) Women in pregnancy or possibly pregnant women or breast feeding women 4) Existence of active inflammation (CRP>2.0) 5) Severe liver dysfunction (GOT>100 IU/l or GPT>100 IU/l) 6) Existence of bone marrow insufficiency: WBC(<3,000/mm3), Hb (<8.0 g/dl), Plt(<10x104/mm3) 7) Renal dysfunction: Cre (adult >1.5 mg/dl, pediatric > 2 x upper limitation of corresponding age and sex) 8) Existence of hemorrhagic diathesis 9) Patients taking anti-coagulants or anti-platelet agents. 10) Existence of mental disorder that makes participation to this study difficult. 11) Poor control of diabetes mellitus 12) Past history of acute myocardial infarction within 3 months or unstable angina. 13) Past history of pulmonary fibrosis or interstitial pneumoniae.
研究者
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