A Phase II Study of Temozolomide (TEMODAR) in the Treatment of Adult Patients With Supratentorial Low Grade Glioma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Response Rate (Complete and Partial Response)
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well temozolomide works in treating patients with supratentorial low-grade glioma.
详细描述
OBJECTIVES:
Primary
- Determine the efficacy of temozolomide, defined as response rate (complete and partial response), in patients with supratentorial mixed low-grade glioma.
Secondary
- Assess the safety profile of temozolomide in patients with supratentorial low-grade glioma.
- Assess the time to tumor progression in patients treated with temozolomide.
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
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Temozolomide
Temozolomide
干预措施: temozolomide (Drug)
结局指标
主要结局
Response Rate (Complete and Partial Response)
时间窗: 12 months
Assessment of treatment response was determined by MRI in conjunction with neurological examination and steroid requirement assessment derived from Macdonald's criteria. Complete response was defined as complete disappearance of lesion on consecutive MRI scans with stable or improved neuro exam and steroids. Partial response was defined as a 50% reduction in lesion size or that tumor burden was "definitely better" than prior scan with stable or improved neuro exam and steroids.
次要结局
- Time to Tumor Progression(time from registration until date of the first documented progression, an average of 1 year)
- Safety Profile(Time from registration up to 13 months)
研究者
Susan Chang
MD
University of California, San Francisco