A Phase II Trial of Radiation Plus Temozolomide Followed by Adjuvant Temozolomide and Poly-ICLC in Patients With Newly Diagnosed Glioblastoma Multiforme
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 9
- 主要终点
- Survival
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Biological therapies, such as poly ICLC, may stimulate the immune system in different ways and stop tumor cells from growing. Giving poly ICLC after radiation therapy and temozolomide may stop any remaining tumor cells from growing.
PURPOSE: This phase II trial is studying how well giving radiation therapy together with temozolomide followed by temozolomide and poly ICLC works in treating patients with newly diagnosed glioblastoma multiforme.
详细描述
OBJECTIVES:
Primary
- Evaluate the safety and efficacy of radiation plus low-dose temozolomide followed by adjuvant temozolomide and intramuscular poly ICLC for adult patients with newly diagnosed glioblastoma multiforme.
Secondary
- Estimate the frequency of toxicity associated with this treatment regimen.
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 120 Years（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
Treatment Arm
RT + TMZ 6wks, followed by
poly ICLC, temozolomide, radiation: radiation therapy
干预措施: poly ICLC (Drug)
Treatment Arm
RT + TMZ 6wks, followed by
poly ICLC, temozolomide, radiation: radiation therapy
干预措施: temozolomide (Drug)
Treatment Arm
RT + TMZ 6wks, followed by
poly ICLC, temozolomide, radiation: radiation therapy
干预措施: radiation therapy (Radiation)
结局指标
主要结局
Survival
时间窗: 30 months
survival time is defined from time of histological diagnosis to death occurrence.
次要结局
未报告次要终点