Phase II Trial Of Poly-ICLC For Glioblastoma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Overall Survival in Pts With Newly Diagnosed GBM
研究概览
简要总结
RATIONALE: Biological therapies such as poly-ICLC use different ways to stimulate the immune system and stop tumor cells from growing. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining biological therapy with radiation therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining poly-ICLC with radiation therapy in treating patients who have newly diagnosed glioblastoma multiforme.
详细描述
OBJECTIVES:
- Determine the efficacy of poly ICLC and radiotherapy, in terms of total survival from date of diagnosis, in patients with newly diagnosed glioblastoma multiforme.
- Determine the safety and toxicity profile of this regimen in these patients.
- Determine the 12-month survival rate in patients treated with this regimen.
- Assess progression-free survival at 6 months and median progression-free survival from date of diagnosis of patients treated with this regimen.
- Assess response in patients treated with this regimen.
- Assess changes in neurological status in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Within 1-4 weeks after surgery, patients receive poly ICLC intramuscularly 3 times weekly (on days 1, 3, and 5). Treatment continues in the absence of disease progression or unacceptable toxicity.
One week after the initiation of poly ICLC, patients undergo external beam radiotherapy once daily 5 days a week for 6 weeks.
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
poly-ICLC Newly diagnosed GBM
Poly-ICLC 20ug/kg 3 times a week (Monday-Wednesday-Friday) starting one week before Radiation Therapy
Intramuscular injection
Drug Poly-ICLC
干预措施: poly ICLC (Drug)
结局指标
主要结局
Overall Survival in Pts With Newly Diagnosed GBM
时间窗: 2 years
Overall survival from surgical diagnosis in patients with Newly Diagnosed GBM
次要结局
- To Determine 6 Months Progression Free Survival(6 months)
- Determine the 12-month Survival Rate(1 year)
- to Determine Grade 3 and 4 Toxicities Associated With Poly-ICLC in Newly Diagnosed Patients(2 years)
- To Determine the Change in Neurological Status in Patients With Glioblastoma Treated With External Beam Radiotherapy and Poly-ICLC(1 year)
- To Determine Tumor Response(2 years)