Phase II Study of the Predictive Value of the Expression of Tumoral MGMT With Respect to the Therapeutic Response of Fotemustine in Patients With Metastatic Malignant Melanoma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Relationship between MGMT expression and response to fotemustine
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as fotemustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors predict how well patients will respond to treatment.
PURPOSE: This phase II trial is studying fotemustine to see how well it works in treating patients with metastatic melanoma.
详细描述
OBJECTIVES:
Primary
- Assess the relationship between MGMT expression and response to fotemustine in patients with metastatic malignant melanoma.
Secondary
- Establish a value for MGMT expression below which fotemustine has a strong probability of effectiveness.
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
Fotemustine
Induction treatment Fotémustine 100mg / m² IV sur 1 h J1, J8, J15
Traitement d'entretien : Fotémustine 100 mg / m² IV sur 1 h - J1 = J21
干预措施: fotemustine (Drug)
结局指标
主要结局
Relationship between MGMT expression and response to fotemustine
时间窗: from date of inclusion to progression documentation
response with criteria OMS
次要结局
未报告次要终点