Toxicity and Activity of Periocular Topotecan in Children With Retinoblastoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Dose limiting toxicity
研究概览
简要总结
This is a dose-escalation study aimed to assess the toxicity (and marginally the activity) of periocular topotecan in patients with relapsed-resistant retinoblastoma.
详细描述
Patients with bilateral retinoblastoma who have relapsed after attempts of conservative therapy with standard regimens such as carboplatin, etoposide, vincristine and external beam radiotherapy who face immediate enucleation of their single remaining eye are eligible for this protocol. Starting dose of topotecan will be 0.5 mg and dose escalation will be done by the accelerated titration method. Any Grade 3 ocular toxicity or grade 4 non ocular toxicity will be designed as the dose limiting toxicity. Grade 2 scleral toxicity will be considered for DLT. In case of grade 2 ocular toxicity or grade 3 systemic toxicity, the escalation dose will be 0.25 mg. Maximal dose will be 2 mg.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Group Vb (Reese Ellsworth)
- •Relapsed or progressed after carboplatin-based regimens and external beam radiotherapy
- •Enucleation of the contralateral eye
- •Normal renal and liver function
排除标准
- •Presence of glaucoma, rubeosis iridis, anterior chamber extension
- •Extraocular disease
- •Adequate follow up impossible for social reasons
结局指标
主要结局
Dose limiting toxicity
次要结局
- Response rate, description of toxicity, pharmacokinetic profile
