A Phase I Trial of the Protease Inhibitor Nelfinavir and Concurrent Radiation and Temozolomide in Patients With WHO Grade IV Glioma
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose of nelfinavir mesylate
研究概览
简要总结
RATIONALE: Nelfinavir mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells. 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. Giving nelfinavir mesylate together with radiation therapy and temozolomide may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of nelfinavir mesylate when given together with radiation therapy and temozolomide in treating patients with glioblastoma multiforme.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of nelfinavir mesylate when given concurrently with radiotherapy and temozolomide followed by temozolomide alone in patients with glioblastoma multiforme.
- Determine the safety and dose-limiting toxicities of this regimen in these patients.
Secondary
- Determine the progression-free survival (PFS) and overall survival (OS) of patients treated with this regimen.
- Compare the observed median values of PFS and OS obtained in this study to the historical median values of 6.9 months and 14.6 months, respectively.
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
Single arm
NFV-RT-Tem
干预措施: nelfinavir mesylate (Drug)
Single arm
NFV-RT-Tem
干预措施: temozolomide (Drug)
Single arm
NFV-RT-Tem
干预措施: adjuvant therapy (Procedure)
Single arm
NFV-RT-Tem
干预措施: radiation therapy (Radiation)
结局指标
主要结局
Maximum tolerated dose of nelfinavir mesylate
时间窗: 90 days
Dose-limiting toxicities as assessed by NCI CTC v3.0
时间窗: 90 days
次要结局
- Progression-free survival(One year)
- Overall survival(5 years)