Bevacizumab in Combination With Irinotecan for Malignant Gliomas
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Activity in terms of progression-free survival
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. Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with irinotecan may kill more tumors cells.
PURPOSE: This phase II trial is studying the side effects of bevacizumab and how well giving bevacizumab together with irinotecan works in treating patients with recurrent or refractory gliomas.
详细描述
OBJECTIVES:
Primary
- Determine the safety of bevacizumab and irinotecan hydrochloride in patients with recurrent or refractory grade 3 or 4 malignant gliomas.
Secondary
- Determine the activity of this regimen, in terms of progression-free survival, in these patients.
研究设计
- 研究类型
- Interventional
- 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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed primary grade 3 or 4 malignant glioma of 1 of the following types:
- •Glioblastoma multiforme
- •Gliosarcoma
- •Anaplastic astrocytoma
- •Anaplastic oligodendroglioma
- •Patients with recurrent disease whose original diagnostic pathology confirmed malignant glioma will not need re-biopsy
- •Measurable recurrent or residual primary disease on contrast-enhanced MRI or CT scan
- •Failed ≥ 1 prior chemotherapy regimen (with or without radiotherapy)
- •PATIENT CHARACTERISTICS:
- •Karnofsky performance status 60-100%
- •Hematocrit > 29%
- •Absolute neutrophil count > 1,500/mm^3
- •Platelets > 125,000/mm^3
- •Serum SGOT and bilirubin < 1.5 times upper limit of normal
- •Creatinine < 1.5 mg/dL
- •Urine protein:creatinine ratio ≤ 1.0
- •Blood pressure ≤ 150/100 mmHg
- •No unstable angina
- •No New York Heart Association class II or greater congestive heart failure
- •No myocardial infarction within the past 6 months
- •No stroke within the past 6 months
- •No clinically significant peripheral vascular disease
- •No evidence of bleeding diathesis or coagulopathy
- •No significant traumatic injury within the past 28 days
- •PRIOR CONCURRENT THERAPY:
- •At least 4 weeks must have elapsed since prior chemotherapy or radiotherapy unless there is unequivocal evidence of tumor progression
- •At least 6 weeks since prior surgical resection
- •No previous major surgical procedures or open biopsies within 28 days prior to study entry
- •No previous minor surgical procedures, fine needle aspirations, or core biopsies within 7 days prior to study entry
- •No anticipated need for major surgical procedures during the course of the study
- •No concurrent aspirin, non-steroidal anti-inflammatory drugs, or clopidogrel
排除标准
- 未提供
结局指标
主要结局
Activity in terms of progression-free survival
Safety
次要结局
未报告次要终点