Phase I/II Trial for Patients With Recurrent Resectable Glioblastoma Multiforme Using Surgery With Implantable BCNU Polymer Followed by Post-operative Irinotecan and Bevacizumab
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- To assess disease free survival
研究概览
简要总结
The purpose of this research study is to try and identify a more effective treatment plan to improve survival rates for patients with a recurrent Glioblastoma Multiforme (GBM) brain tumor that can be removed by brain surgery.
The study will record what effects (good and bad) the combination of surgery with chemotherapy wafers inserted in the spot where the patient's tumor was during your surgery and post-operative chemotherapy has on the patient and their survival rate over the next 12 months.
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
- •Histopathologically proven diagnosis of GBM in the past with MRI findings compatible with disease recurrence. Multifocal disease is permitted.
- •Must have had prior treatment with standard doses of Temodar
- •KPS >50; ECOG <3
- •Predicted life expectancy of > 3 months
- •Study entry must be within 5 weeks of surgical resection
排除标准
- •Prior exposure to VEGF inhibitors or Irinotecan
- •Intracranial bleed as defined by CT or MRI less than 6 months prior to entry
- •GI bleed less than 6 months prior to entry
- •Uncontrolled concurrent illness that would limit compliance with study requirements
研究组 & 干预措施
BCNU wafter followed by chemotherapy
Surgical Implantable BCNU wafer followed by Chemotherapy with Irinotecan and Bevacizumab for up to one year
干预措施: Irinotecan (Drug)
BCNU wafter followed by chemotherapy
Surgical Implantable BCNU wafer followed by Chemotherapy with Irinotecan and Bevacizumab for up to one year
干预措施: Bevacizumab (Drug)
BCNU wafter followed by chemotherapy
Surgical Implantable BCNU wafer followed by Chemotherapy with Irinotecan and Bevacizumab for up to one year
干预措施: BCNU Wafer (Drug)
结局指标
主要结局
To assess disease free survival
时间窗: 6 and 12 months
次要结局
未报告次要终点