A Phase I/II trial of Temozolomide and ACNU Combination Chemotherapy for Patients with Recurrent Malignant Glioma - A Phase I/II trial of Temozolomide and ACNU Combination Chemotherapy for Patients with Recurrent Malignant Glioma

Department of Neurosurgery Kyoto University Graduate School of Medicine0 个研究点目标入组 49 人开始时间: 2011年9月12日最近更新: 2023年10月17日

适应症

试验速览

阶段: 1 期
状态: 已完成
发起方
入组人数: 49

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

Eligible patients: 49(I:15, II:40). Median age: 50. Histology: glioblastoma(73%), anaplastic astrocytoma(22%), anaplastic oligodendroglioma(4%). Phase I: MTD: TMZ 150 mg/m2 plus ACNU 40 mg/m2. Phase II: Toxicity: mainly grade 3 or 4 hematological. PFS at 6 and 12 months: 24%(95% CI, 12-35%) and 8% (95% CI, 4-15%). Median PFS: 13 months (95% CI, 9.2-17.2 months). OS at 6 and 12: 78% (95% CI, 67-89%) and 49% (95% CI, 33-57%). Median OS: 11.8 months (95% CI, 8.2-14.5 months).

研究设计

研究类型: Interventional

入排标准

年龄范围: 20years-old 至 80years-old（—）
性别: All

入选标准

未提供

排除标准

•1) After two chemotherapy regimens 2) Co-existence of uncured cancer. 3) Infection with systemic therapy indicated 4) fever over 38 degrees Celsius 5) Co-existence of meningitis 6) Women during pregnancy, possible pregnancy or breast-feeding 7) Psychosis 8) Uncontrollable diabetes mellitus or administration of insulin 9) Unstable angina within 3 weeks, or with a history of myocardial infarction within 6 months 10) Interstitial pneumonia, or fibroid lung 11) Patients who can 't receive gadolinium 12) After stereotactic radiation or boron neutron capture therapy 13) Symptomatic cerebrovascular disease

研究者

发起方

Department of Neurosurgery Kyoto University Graduate School of Medicine

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