A Phase II Trial of Poly ICLC in Patients With Recurrent Anaplastic Glioma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 8
- 主要终点
- Proportion of Participants With Objective Response Rate (ORR)
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.
PURPOSE: This phase II trial is studying how poly-ICLC works in treating patients with recurrent, progressive, or relapsed anaplastic glioma.
详细描述
OBJECTIVES:
- Determine the objective response rate in patients with recurrent or progressive anaplastic glioma treated with poly ICLC.
- Determine the efficacy of this drug, in terms of 6-month progression-free survival, in these patients.
- Determine the safety profile of this drug in these patients.
- Determine the survival of patients treated with this drug.
- Determine the tumor response rate in patients treated with this drug.
- Determine the biological effects of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive poly ICLC intramuscularly 3 times a week for 4 weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 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 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 Recurrent gliomas
Poly-ICLC 20ug/kg 3 times a week 4 week cycles (Monday-Wednesday-Friday)
Intramuscular injection
Drug Poly-ICLC
干预措施: poly ICLC (Drug)
结局指标
主要结局
Proportion of Participants With Objective Response Rate (ORR)
时间窗: 2 years
Measurable: Bidimensionally measurable lesions w/ clearly defined margins by MRI Evaluable: Unidimensionally measurable lesions, masses w/margins not clearly defined. Complete Response (CR): Complete disappearance of all measurable/evaluable disease. No new lesions. No evidence of non-evaluable disease. Patients on minimal/no steroids. Partial Response (PR): \>/= to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. Responders must be on same/decreasing doses of dexamethasone. Stable/No Response: Does not qualify for CR, PR, or progression. Progression: 25% increase in the sum of products of all measurable lesions over smallest sum observed (over BL if no decrease), OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer). ORR = CR + PR
Percentage of Participants With Progression Free Survival
时间窗: 6 months
Participants evaluated from date of study entry to the 6 month scan for progression
次要结局
- Number if Participants With Grade 3 and 4 Toxicities Associated With Poly-ICLC in Recurrent Gliomas(2 years)
- Overall Survival(2 years)