A Phase II Trial of Bevacizumab for Patients With Recurrent High-Grade Gliomas
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Progression Free Survival at 6 Months.
研究概览
简要总结
Background:
Bevacizumab is a genetically engineered antibody that blocks the growth of new blood vessels in tumors. Inhibiting the formation of these blood vessels may slow or stop disease progression by diminishing the supply of life-sustaining nutrients and oxygen the blood delivers to the tumor.
Bevacizumab is approved for treating colorectal cancer and has shown activity against brain tumor cells in laboratory and animal tests.
Objectives:
To examine the safety and side effects of bevacizumab in patients with recurrent brain tumors.
To determine the anti-tumor activity of bevacizumab in patients with recurrent brain tumors.
Eligibility:
Patients 18 years of age and older with a brain tumor that continues to grow after receiving standard treatments.
Design:
Patients complete the following procedures during the study:
- Infusions of bevacizumab through a vein once every 2 weeks in 4-week treatment cycles.
- Positron emission tomography (PET) scan before the first dose of bevacizumab, at the end of the first treatment cycle, and as needed after that.
- Magnetic resonance imaging (MRI) scan before the first dose of bevacizumab, within 48-96 hours after the first dose of bevacizumab in the first treatment cycle, and then every 4 weeks. One tube of blood for research is collected at the time of each MRI scan to look at specific cells.
- Physical and neurological examinations every 2 weeks for the first treatment cycle and then every 4 weeks.
- Quality-of-life questionnaires every 4 weeks.
详细描述
Background
- In vivo experiments have documented the ability of anti-vascular endothelial growth factor (VEGF) antibodies like bevacizumab to inhibit tumor growth in various preclinical tumor models, including gliomas.
- Given the pronounced neovasculature associated with over-expression of VEGF in malignant gliomas, and abundant published data demonstrating the dependence of glioma growth on the maintenance and proliferation of this neovasculature, bevacizumab represents a potentially promising new therapeutic approach to these otherwise refractory tumors.
Objective
- To establish data regarding the anti-tumor activity of bevacizumab in patients with recurrent high-grade gliomas as determined by progression-free-survival.
- To obtain information regarding the safety of bevacizumab administered to patients with recurrent high-grade gliomas.
Eligibility
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
Anaplastic Glioma (AG)
Anaplastic astrocytoma Anaplastic oligodendroglioma Anaplastic mixed oligoastrocytoma Malignant astrocytoma (not otherwise specified) 10 mg/kg intravenously over 90 minutes every 2 weeks on a 28 day cycle. First dose is given over 90 minutes and subsequent doses are given over 30 minutes.
干预措施: Bevacizumab (Drug)
Glioblastoma Multiforme (GBM)
Glioblastoma multiforme Gliosarcoma 10 mg/kg intravenously over 90 minutes every 2 weeks on a 28 day cycle. First dose is given over 90 minutes and subsequent doses are given over 30 minutes.
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Percentage of Participants With Progression Free Survival at 6 Months.
时间窗: 6 months
Percentage of participants surviving without progression of disease after six months of study entry. Progression is defined as a 25% increase in lesions, clear worsening of any evaluable disease, or appearance of any new lesion/site (e.g. by computed tomography, magnetic resonance imaging), or failure to return for evaluation due to death or deteriorating condition.
Number of Participants With Adverse Events
时间窗: 5 years
Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.
次要结局
未报告次要终点
研究者
Teri Kreisl, M.D.
Principal Investigator
National Institutes of Health Clinical Center (CC)