JPRN-jRCTs021180011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
Tominaga Teiji0 个研究点目标入组 35 人开始时间: 2019年3月25日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 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
- •1) Cases diagnosed clinically as well as radiologically as recurrent glioma at brainstem will be recruited. Recurrent cases of diffuse brainstem glioma as well as recurrent cases of gliomas originating from surrounding structure, i.e. thalamus, cerebellum, etc, and infiltrating brainstem will be included. In the recurrent cases of glioma originating from surrounding structure, histological diagnosis of the initial tumor is necessary. Since the disease occupy brainstem region, histological diagnosis of brainstem lesion is not necessary.
- •2) Recurrent cases after treatment with radiation therapy.
- •3) At least 4 weeks interval from prior radiation and/or chemotherapy.
- •4) Appropriate systemic condition: WBC (>3,000/mm3), Hb (>8.0 g/dl), Plt (>10x104/mm3), GOT (<100 IU/l), GPT (<100 IU/l), Cre (adult<1.5 mg/dl, pediatric<2 x upper limitation of corresponding age and sex) should be cleared.
- •5) Informed consent taken from the patient. In case it is difficult to get the signature of patient due to neurological deficits, representative person may sign as long as patient is able to understand and give his approval.
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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