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临床试验/JPRN-UMIN000005125
JPRN-UMIN000005125已完成1 期

Phase I study of Convection-enhanced delivery of Nimustine Hydrochloride combined with oral Temozolomide against recurrent gliomas at brainstem - CED of ACNU plus oral TMZ against recurrent gliomas at brainstem: Phase I study

Department of Neurosurgery, Tohoku University Graduate School of Medicine0 个研究点目标入组 15 人开始时间: 2011年2月22日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
15

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) Pregnant women 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 (>1.5 mg/dl) 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

发起方
Department of Neurosurgery, Tohoku University Graduate School of Medicine

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