The Efficacy and Safety of Temozolomide in Patients With Relapsed or Advanced Anaplastic Oligodendroglioma and Oligoastrocytoma: a Multicenter, Single-arm, Phase II Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Progression free survival (PFS)
研究概览
简要总结
The purpose of this study is to determine the efficacy and safety of temozolomide in patient with relapsed or advanced anaplastic oligodendroglioma and anaplastic oligoastrocytoma.
详细描述
Patient with relapsed or advanced anaplastic oligodendroglioma and anaplastic oligoastrocytoma will be enrolled. Enrolled patients will begin on temozolomide 200 mg/m2/d in a fasting state for 5 consecutive days (1,000 mg/m2 per 28-day cycle). Patients who were previously treated with any chemotherapy initially received temozolomide 150 mg/m2/d for 5 days (750 mg/m2 per cycle).Patients will be receving a total 6 cycles of chemotheray (4weeks/cycle * 6cycles = 24weeks). If the patients shows responses to Temozolomide, treatment can be continued by the investigator's discretion.
During the administration of Temozolomide, vital signs, physical examination, ECOG performance status, height, weight, hematology and chemistry test, adverse events and concomitant drugs will be evaluated every four weeks. Brain MRI for tumor assessment will be performed once every 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven anaplastic oligodendroglioma or oligoastrocytoma
- •Progressed or relapsed after surgery or radiation therapy
- •Female or male aged 20 years or over
- •At least 1 measurable mass lesion
- •ECOG performance status 0-3
- •Adequate organ function
- •absolute neutrophil count > 1,500/μL
- •platelet count > 75,000/μL
- •hemoglobin greater than 9 g/dL or 900g/L
- •serum creatinine less than 1.5 times the upper limit of laboratory normal
- •total serum bilirubin less than 1.5 times the upper limit of laboratory normal
- •AST or ALT less than three times the upper limit of laboratory normal
排除标准
- •Prior course of temozolomide
- •Combined glioblastoma
- •Pregnant woman
研究组 & 干预措施
Temozolomide
Temozolomide 200 mg/m2/d in a fasting state for 5 consecutive days
干预措施: Temozolomide (Drug)
结局指标
主要结局
Progression free survival (PFS)
时间窗: 6 month
PFS will be examined with Kaplan-Meier method.
次要结局
- Overall survival (OS)(1 years)
- progression-free survival (PFS)(1 year)
- Objective response rate (ORR)(1 year)
- Number of Participants with Adverse Events(1 years)
研究者
Tae Min Kim
Associate Professor
Seoul National University Hospital
