A Phase I Trial of Vorinostat Concurrent With Stereotactic Radiotherapy in Treatment of Brain Metastases From Non-Small Cell Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- The radiologic response, defined as local control and distant intra-cranial control rates at 3-months following radiotherapy, will be determined.
研究概览
简要总结
The purpose of this study is to determine the maximum tolerated dose (MTD) of vorinostat given concurrently with stereotactic radiosurgery (SRS) to treat non-small cell lung cancer (NSCLCA) brain metastases in patient with 1-4 lesions.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients age 18 years and older with histologically proven non-small cell lung cancer and 1-4 brain metastases, each measuring less than 2 cm will be eligible. Prior surgery or radiation is allowed as long as the target metastatic lesion(s) has not been treated with previous radiation.
- •Adequate organ function (section 3.1.10).
- •ECOG performance status 0-
- •Life expectancy of >=12 weeks.
- •Systemic chemotherapy washout period >=7 days.
排除标准
- •Patients who have previously been treated with whole brain irradiation, pediatric patients (age <18), pregnant women, and patients who are unable to give informed consent.
研究组 & 干预措施
vorinostat & stereotactic radiosurgery
干预措施: Vorinostat (Drug)
vorinostat & stereotactic radiosurgery
干预措施: Radiation Therapy (Procedure)
结局指标
主要结局
The radiologic response, defined as local control and distant intra-cranial control rates at 3-months following radiotherapy, will be determined.
时间窗: 3 months following Stereotactic Radiosurgery
The maximum tolerated dose of vorinostat with concurrent radiosurgery will be determined.
时间窗: 30 days following Stereotactic Radiosurgery
During the expanded phase I portion of the study, the safety of the Maximum tolerated dose dose will be confirmed.
时间窗: 30 days following Stereotactic Radiosurgery
次要结局
- The short-term (< 30 days post-treatment) and long-term (> 30 days post-treatment) adverse effects will be determined.(12 months)
- The 12-month survival rate from the date of Stereotactic Radiosurgery will be determined.(12 months)
研究者
Griffith R Harsh
Professor of Neurosurgery
Stanford University