Analysis of Different Circulating Immune Cells in Patients With Recurrent Glioblastoma or Mixed Anaplasic Glioma Treated With Bevacizumab and Search for a Link With Response to Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- blood cells populations
研究概览
简要总结
Bevacizumab, a monoclonal antibody against vascular endothelial growth factor (VEGF), is an antiangiogenic treatment currently proposed to recurrent high grade glioma patients. Unfortunately some patients fail to respond to this treatment and finding biological factors allowing the discrimination between potential responders and non responders would be very helpful. As the immune system plays a key role in angiogenesis induction and maintenance in cancer, it could serve as a surrogate marker of angiogenesis in cancer patients.
The purpose of this study is to determine the influence of bevacizumab treatment on circulating immune cells in high grade glioma patients and to search for a link between the variation of these cells and the response to treatment.
详细描述
The following leucocyte subsets will be analyzed in whole blood before treatment and before cycles 3, 5 and 7:
- Classical, intermediate, nonclassical and Tie2 expressing monocytes.
- Regulatory T cells (Treg).
- Myeloid Derived Suppressor cells (MDSCs) The variation of the absolute numbers (or relative percentages) of the cells in the blood of patients will be correlated to the response to treatment assessed according to the RANO criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Patients with histologically proved recurrent glioblastoma or anaplasic glioma,
- •Tumor recurrence documented by MRI at least 3 months after the end of radiotherapy or chemotherapy.
- •Patients for whom a treatment by bevacizumab is proposed by a multidisciplinary team staff.
- •Signed informed consent.
- •Affiliation to a social security coverage
排除标准
- •Known Hepatitis B or C or HIV.
- •Inclusion in another clinical trial.
- •Patient having received an anti-angiogenic therapy.
- •Pregnant or breast-feeding woman.
- •Person deprived of liberty or under guardianship or trusteeship or judicial protection
- •Inability to give informed consent
- •Person unable or unwilling to comply with the requirements of the protocol for geographical, social or psychological reasons.
研究组 & 干预措施
BEVACIZUMAB
BEVACIZUMAB standard of care
干预措施: Bevacizumab standard of care (Drug)
结局指标
主要结局
blood cells populations
时间窗: up to 4 months
Analysis of blood cells populations variation during treatment with bevacizumab. Last sampling planned before the 7th cycle of bevacizumab.
次要结局
- Cells variation and RMI response(6 weeks)
- Survival(Patients will be followed up from the date of randomization up to their death, assessed up to 100 months)