Phase I/II Trial of Radiosurgery Plus Bevacizumab in Patients With Recurrent/Progressive Glioblastoma
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Overall survival of patients with recurrent GBM treated with bevacizumab, irinotecan and radiosurgery
研究概览
简要总结
RATIONALE: Radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of glioblastoma by blocking blood flow to the tumor. Drugs used in chemotherapy such as irinotecan hydrochloride work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiosurgery together with bevacizumab and irinotecan hydrochloride may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving radiosurgery together with bevacizumab and irinotecan hydrochloride works in treating patients with recurrent glioblastoma.
详细描述
PRIMARY OBJECTIVES:
I. To determine the overall survival of patients with recurrent GBM treated with bevacizumab, irinotecan and radiosurgery
SECONDARY OBJECTIVES:
I. To evaluate the toxicities of the combination of bevacizumab, irinotecan and radiosurgery.
II. To evaluate the progression-free survival of patients treated with bevacizumab, irinotecan and radiosurgery.
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
Arm I
Patients receive bevacizumab IV over 30 minutes on days 1 and 15. Patients also receive irinotecan hydrochloride IV on days 1 and 15 beginning in course 2. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo radiosurgery 10-14 days after beginning bevacizumab.
干预措施: radiosurgery (Radiation)
Arm I
Patients receive bevacizumab IV over 30 minutes on days 1 and 15. Patients also receive irinotecan hydrochloride IV on days 1 and 15 beginning in course 2. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo radiosurgery 10-14 days after beginning bevacizumab.
干预措施: bevacizumab (Biological)
Arm I
Patients receive bevacizumab IV over 30 minutes on days 1 and 15. Patients also receive irinotecan hydrochloride IV on days 1 and 15 beginning in course 2. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo radiosurgery 10-14 days after beginning bevacizumab.
干预措施: irinotecan hydrochloride (Drug)
结局指标
主要结局
Overall survival of patients with recurrent GBM treated with bevacizumab, irinotecan and radiosurgery
时间窗: Patients are followed for 18 months.
次要结局
- Treatment-related toxicity(Courses repeat every 28 days in the absence of unacceptable toxicity.)
- Progression-free survival, defined as the interval from randomization to progression or death, whichever occurs first(Patients are followed for 18 months.)