Intravitreal Injections of Melphalan for Retinoblastoma
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- treatment response
研究概览
简要总结
Retinoblastoma treatment has become more and more focused in the last years. New treatments developed by Dr. Kaneko from Japan in 1995 are now being tested in clinical trials.
Intra-arterial chemotherapy with Melphalan has shown success in some patients but with limited response when there is marked vitreal seeding. For these cases Intravitreal injections of Melphalan have been successful in Japan.
In this study the same chemotherapy (melphalan) will be administered intravitreally (directly through the eye wall) and the response (short and long term) will be monitored.
详细描述
Intravitreal injections of Melphalan will be given to cases unresponsive to chemotherapy or with vitreal seeding of the disease.
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
- — 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Retinoblastoma that has not responded to chemotherapy
- •Retinoblastoma that has vitreal seeding
排除标准
- •previous failure of IVit Melphalan
研究组 & 干预措施
IVit Treatment group
Intravitreal injections of Melphalan
干预措施: IVit Melphalan (Drug)
结局指标
主要结局
treatment response
时间窗: 1 year
short term response to treatment and long term complications
次要结局
- complications(1 year)