Phase II Study of 7 Days On/7 Days Off Temozolomide in Patients With High-Grade Glioma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 6 Month Progression-free Survival
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 recurrent high-grade glioma.
详细描述
OBJECTIVES:
Primary
- Determine the efficacy, as measured by 6-month progression-free survival, of a dose-intense temozolomide treatment schedule in patients with recurrent high-grade glioma.
Secondary
- Assess the toxicities of this dose-intense temozolomide.
- Determine the overall survival of patients treated with this dose-intense schedule.
- Determine whether methylation status of the MGMT gene within patients' tumors predicts greater efficacy (progression-free survival), in patients treated on this protocol.
- Determine whether patients' tumors have functional alterations of the mismatch repair (MMR) system by PCR analysis for microsatellite instability (MSI) and whether such alterations may influence outcome in patients treated on this protocol.
- Determine how initial success with temozolomide may influence outcome in recurrent patients treated on this protocol by evaluating patients progressing after two first-line adjuvant courses of temozolomide, patients progressing within 6 months after the 6th adjuvant course of temozolomide, and patients progressing 6 months after temozolomide is voluntarily discontinued.
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 —（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
single arm trial; Patients treated with temozolomide at a dose of 150mg/m2 daily for seven consecutive days of every other week. One 28-day cycle will include treatment with temozolomide on days 1-7 and days 15-21 with no treatment on days 8-14
干预措施: temozolomide (Drug)
结局指标
主要结局
6 Month Progression-free Survival
时间窗: First day of treatment until progression or until 6 months mark
Efficacy of dose-intense temozolomide treatment schedule, as measured by 6 months progression-free survival
次要结局
- Patients With Tumors With Functional Alterations of the Mismatch Repair (MMR) System(prior to start of study)
- Patients Progressing After Two First-line Adjuvant Courses of Temozolomide(After two first-line adjuvant courses of temozolomide)
- Patients Progressing Within 6 Months After 6th Adjuvant Course of Temozolomide(Within 6 months after 6th adjuvant course of temozolomide)
- Patients Progressing 6 Months After Temozolomide is Voluntarily Discontinued(From beginning of voluntarily temozolomide discontinued up to 6 months)
- Progression-free Survival (PFS) Based on Tumor MGMT (O(6)-Methylguanine-DNA Methyltransferase) Promoter Methylation Status.(First day of treatment until progression or until 6 months mark)
- Overall Survival(up to 2 years after treatment)