A Phase II Trial of Riluzole in Patients With Advanced Melanoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Tumor Response as Measured by RECIST Criteria
研究概览
简要总结
RATIONALE: Riluzole may stop or slow the growth of tumor cells and may be an effective treatment for melanoma.
PURPOSE: This phase II trial is studying how well riluzole works in treating patients with stage III or stage IV melanoma that cannot be removed by surgery.
详细描述
OBJECTIVES:
Primary
- Determine whether administration of a daily dose of riluzole results in tumor shrinkage, as measured by RECIST criteria, in patients with advanced melanoma.
Secondary
- Determine the long-term toxicity of riluzole when administered to these patients.
- Compare the survival of these patients with historical controls.
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
Riluzole
100 mg orally twice daily
干预措施: riluzole (Drug)
结局指标
主要结局
Tumor Response as Measured by RECIST Criteria
时间窗: Imaging for tumor assessments was performed after 6 weeks
Per Response Evaluation Criteria in Solid Tumors (RECIST v1.0) for target lesions and assessed by CT or MRI imaging: Complete response (CR) - disappearance of all target lesions; Partial response (PR) - \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) - At least a 20% increase in the sum of the longest diameter of target lesions; or Stable Disease (SD) - neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
次要结局
- Number of Participants With at Least One Adverse Event(From date of randomization through completion of follow-up, up to three years)
- Overall Survival(Overall survival at one year)