A Phase II Safety Study of Bevacizumab in Patients With Multiple Recurrent or Progressive Malignant Gliomas
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 4
- 主要终点
- Progression-free Survival at 6 Months
研究概览
简要总结
RATIONALE: 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 tumor cells by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well bevacizumab works in treating patients with recurrent or progressive glioma.
详细描述
OBJECTIVES:
- Determine the safety of single-agent bevacizumab in the treatment of patients with recurrent or progressive malignant glioma.
- Determine the efficacy of bevacizumab, in terms of progression-free survival at 6 months, in these patients.
- Assess changes in tumoral blood flow based on magnetic resonance (MR) perfusion and tissue changes by MR spectroscopy.
OUTLINE: This is a pilot study.
Patients receive bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
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
结局指标
主要结局
Progression-free Survival at 6 Months
时间窗: After all patients have surpassed the 6 month post-treatment timepoint
The number of patients experiencing progression free survival (PFS) was calculated at the 6-month time point.
Safety of Treatment
时间窗: From treatment initiation, throughout treatment and up to 30 days post-treatment, for up to 1 year.
Safety of treatment will be defined by the number of patients that experience grade 3 and 4 adverse events where causal relationship with bevacizumab cannot be completely ruled out. Adverse events will be graded using Common Terminology Criteria for Adverse Events v3.0 (CTCAE) where: Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE
Tumoral Blood Flow Changes
时间窗: Before and after treatment
To assess changes in tumoral blood flow based on MR Perfusion and tissue changes by MR spectroscopy.
次要结局
未报告次要终点
研究者
Jeffrey Raizer
Jeffrey Raizer, MD
Northwestern University