DMS 0947 Exploratory Study of the Modulation of the Immune System by Vascular Endothelial Growth Factor (VEGF) Blockade in Patients With Glioblastoma Multiforme (GBM)
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Changes in the peripheral blood T-reg profile between pretreatment and 4 weeks after completion of treatment with the addition of bevacizumab to RT and TMZ in patients with glioblastoma
研究概览
简要总结
Blood samples will be obtained from newly diagnosed GBM patients treated with combined radiotherapy (RT), temozolomide (TMZ) and bevacizumab (BEV) at specific time points. The primary outcome is the shift in T reg cell fraction a defined by determining the proportion of CD4 cells that are CD4+ CD25.
详细描述
Glioblastoma multiforme (GBM) is the most frequent malignant brain tumor and it remains a lethal disease. Approximately 4 weeks post surgery for tumor resection, patients will proceed to standard of care treatment which currently consists of temozolomide (TMZ) with concurrent radiation therapy (RT) for 6 weeks. This study will add bevacizumab (BEV) to the standard of care regimen in newly diagnosed patients. The Bevacizumab will be added 2 weeks post start of RT/TMZ. Administration of bevacizumab will continue concurrently with TMZ every 2 weeks for 12 months. Blood samples will be obtained from these patients at 3 different time points during this study.
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
- •Histologically proven GBM
- •Karnofsky status equal to or greater than 60%
排除标准
- •Inadequately controlled hypertension
- •Prior history of hypertension crisis or hypertensive encephalopathy
- •History of stroke or transient ischemic attach within 12 months
研究组 & 干预措施
Bevacizumab
Bevacizumab + temozolomide + radiotherapy followed by adjuvant bevacizumab + temozolomide
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Changes in the peripheral blood T-reg profile between pretreatment and 4 weeks after completion of treatment with the addition of bevacizumab to RT and TMZ in patients with glioblastoma
时间窗: 1 year
次要结局
- Immunologic shift in the phenotypic T cell, B cell, NK cell and DC repertoire induced by RT-TMZ-BEV comparing pretreatment and 4 weeks after completion of treatment(1 year)
研究者
Lionel.D.Lewis, MD
Professor
Dartmouth-Hitchcock Medical Center