Lucentis in the Treatment of Retinoblastoma - A Phase II, Single Center, Randomized Study to Evaluate the Efficacy of Ranibizumab in Subjects With Retinoblastoma
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- all cause mortality
研究概览
简要总结
This study will evaluate the clinical efficacy of intravitreal injections of Ranibizumab (Lucentis) together with chemotherapy in the treatment of Retinoblastoma as compared to chemotherapy alone.
详细描述
This study will be a phase II open label interventional case series. Patients with retinoblastoma will be randomized to receive chemotherapy with or without intravitreal ranibizumab at a dose of 0.5mg/0.05 ml. Patients will receive ranibizumab via a pars plana injection on a monthly basis for a total duration of therapy of 6 months. Patients will be followed for 24 months .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to provide written informed consent and comply with study assessments for the full duration of the study.
- •Definite characteristic signs of retinoblastoma,Group D base on Intraocular International Retinoblastoma classify, IIRC.
排除标准
- •History of surgical intervention for retinoblastoma in the study eye.
- •Any previous disease in the study eye.
- •Previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals).
- •Previous participation in a clinical trial (for either eye) involving anti angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, protein kinase C inhibitors, etc.)
研究组 & 干预措施
Lucentis; chemotherapy
Lucentis: 0.5mg/0.05 ml;Other Name: Ranibizumab;monthly for the first six months.
Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months.
干预措施: Lucentis, chemotherapy (Drug)
chemotherapy
chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months.
干预措施: chemotherapy (Drug)
结局指标
主要结局
all cause mortality
时间窗: two years
measure the mortality rate for the two groups(Cancer-related death and non-Cancer-related death) at two years
次要结局
- Efficacy of Lucentis(intravitreal injection) in the Treatment of Retinoblastoma(two years)
研究者
Huasheng Yang
Efficacy Study of Lucentis in the Treatment of Retinoblastoma
Sun Yat-sen University