Phase II Trial of Bevacizumab in Patients With Recurrent or Progressive Meningiomas
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 9
- 主要终点
- Progression Free Survival (PFS) of Patients With Recurrent or Progressive Meningiomas Treated With Bevacizumab 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.
PURPOSE: This phase II trial is studying how well bevacizumab works in treating patients with recurrent or progression meningiomas.
详细描述
PRIMARY OBJECTIVES:
I. To determine the efficacy of bevacizumab in patients with recurrent or progressive benign and atypical/malignant meningiomas, despite prior therapy, as measured by six-month progression-free survival.
SECONDARY OBJECTIVES:
I. To describe the response rate and overall-survival in this patient population.
II. To evaluate the safety profile of bevacizumab in patients with recurrent meningiomas.
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 (PFS) of Patients With Recurrent or Progressive Meningiomas Treated With Bevacizumab at 6 Months
时间窗: From the start of treatment and up until 6 months of treatment or follow up
Progression Free Survival (PFS) of patients with recurrent or progressive benign and atypical/malignant Meningiomas (grades I-III), despite prior therapy treated with bevacizumab will be defined from the time of registration to the study until the time of first documentation of progressive disease or death from any cause. Progressive disease will be assessed based on the Macdonald Criteria and is defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, or clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR clear worsening or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
次要结局
- Safety Profile of Bevacizumab(Every 2 weeks or 3 weeks while on treatment up to 30 days after the last dose. The maximum duration any one patient was on treatment was approximately 5 years.)
- Number of Patients With Each Response(From start of treatment and approximately every 8 weeks for up to approximately 5 years ( maximum duration any one patient was on treatment))
- Levels of VEGF, VEGRfR2 and HER2 Expression in Tumor Tissue as Compared to Response(At baseline and every 8 weeks until disease progression or death. The maximum duration any one patient was on treatment was approximately 5 years.)
- Number of Patients Alive at 1 Year, 2 Years and 3 Years Post Treatment Initiation (Overall Survival) for Patients With Recurrent or Progressive Meningiomas Treated With Bevacizumab(At 1 year, 2 years, 3 years post treatment initiation)