A Phase II Window Study of Front-line Axitinib Followed by Axitinib and Radiation for Elderly Patients With Glioblastoma Multiforme (GBM)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
The purpose of this study is to determine whether the addition of an investigational medication, axitinib, to radiation therapy will improve the outcome of treatment in patients, above the age of 70.
详细描述
The addition of axitinib to standard treatment is experimental and has not been approved by the United States Food and Drug Administration (FDA). Axitinib works by preventing new blood vessels from forming, and tumors need to make new blood vessels in order to grow. The study will find out what effects, good or bad, axitinib has on the tumor. In addition, this study will try to determine whether the response to axitinib and the overall outcome depends on certain characteristics of your tumor.
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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed patients with histologically proven glioblastoma multiforme
- •Age above 70 years
- •Karnofsky score of 50-80
- •Adequate organ function as defined by laboratory values
- •Life expectancy of >12 weeks
- •No evidence of preexisting uncontrolled hypertension as documented by 2 baseline blood pressure readings taken at least 1 hour apart. The baseline systolic blood pressure readings must be 140 mm Hg, and the baseline diastolic blood pressure readings must be 90 mm Hg. Patients whose hypertension is controlled by antihypertensive therapies are eligible.
排除标准
- •Prior treatment with chemotherapy or radiation for glioblastoma multiforme
- •Patients with extensive tumor hemorrhage
- •Any of the following within the 12 months prior to study drug administration: myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack and 6 months for deep vein thrombosis or pulmonary embolism
研究组 & 干预措施
Axitinib + Radiation Therapy
Axitinib 5mg twice daily for 28 days followed by concurrent axitinib plus hypofractionated radiation therapy (45 Gy in 15 fractions) followed by maintenance axitinib 5mg twice daily until progression or unacceptable toxicity
干预措施: Axitinib (Drug)
Axitinib + Radiation Therapy
Axitinib 5mg twice daily for 28 days followed by concurrent axitinib plus hypofractionated radiation therapy (45 Gy in 15 fractions) followed by maintenance axitinib 5mg twice daily until progression or unacceptable toxicity
干预措施: Radiation Therapy (Radiation)
结局指标
主要结局
Overall Survival
时间窗: average 1 year
次要结局
未报告次要终点
研究者
Rekha Chaudhary
Adjunct Assistant Professor
University of Cincinnati