A Systemic Temozolomide Treatment Of Melanoma Present In The Central Nervous System
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 41
- 试验地点
- 45
- 主要终点
- Confirmed response rate
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as temozolomide, use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining temozolomide with radiation therapy may make the tumor cells more sensitive to radiation therapy and kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving temozolomide together with radiation therapy works in treating patients with stage IV malignant melanoma with measurable and unresectable cancer limited to the central nervous system.
详细描述
OBJECTIVES:
Primary
- Determine the response rate in patients with stage IV malignant melanoma with measurable and unresectable disease of the central nervous system treated with temozolomide and radiotherapy.
Secondary
- Determine the safety of this regimen in these patients.
- Determine the survival of patients treated with this regimen.
- Determine the effect of this regimen on performance status and mental status of these patients.
- Determine the response of extra-cranial disease in patients treated with this 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 —（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
radiation + temozolomide
Patients receive concurrent chemoradiotherapy comprising whole brain radiotherapy daily on days 1-5, 8-13, and 16-21 and oral temozolomide daily on days 1-5. Subsequent treatment with temozolomide repeats every 4 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months.
干预措施: temozolomide (Drug)
radiation + temozolomide
Patients receive concurrent chemoradiotherapy comprising whole brain radiotherapy daily on days 1-5, 8-13, and 16-21 and oral temozolomide daily on days 1-5. Subsequent treatment with temozolomide repeats every 4 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months.
干预措施: radiation therapy (Radiation)
结局指标
主要结局
Confirmed response rate
时间窗: Up to 5 years
次要结局
- Overall survival(Up to 5 years)
- Change in performance status(Up to 5 years)
- Progression-free survival(Up to 5 years)