A Phase II Study of Topotecan in Children With Recurrent Wilms Tumor
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 7
- 主要终点
- Response rate (complete and partial response as per RECIST criteria).
研究概览
简要总结
In spite of the overall success of treating Wilms tumor, certain patients still have poor clinical outcomes. The sub-optimal outcomes for patients with anaplastic histology and recurrent Wilms tumor warrant the identification of new therapeutic agents. The objective of this trial is to estimate the response rate to two cycles of intravenous topotecan in children with recurrent Wilms tumor of favorable histology that is refractory to standard curative therapy.
详细描述
Topotecan administered intravenously over 30 minutes daily for 5 consecutive days for 2 consecutive weeks, with a two-day rest given in between the five-day treatment blocks. The topotecan dose started at 1.8 mg/m2/dosage and adjusted to attain a target systemic exposure of 80 plus or minus 10 ng-hr/ml.each cycle consists of 28 days and subsequent cycles can be administered upon hematological recovery. Patients with a CR, PR, or SD, can continue to receive up to a total of six cycles. Patients with PD are removed from the study.
Secondary Objectives include:
- To describe the anti-tumor activity of topotecan in children with recurrent Wilms tumor of anaplastic histology.
- To assess the relation between CYP3A4/5 genotype and the pharmacokinetics and pharmacodynamics of topotecan.
- To assess the relation between ABCG2 genotype and the pharmacokinetics and pharmacodynamics of topotecan.
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 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Favorable histology Wilms tumor that has recurred or progressed after primary treatment and at least one standard salvage treatment regimen OR anaplastic histology Wilms tumor that has recurred or progressed after primary treatment
- •Age< 21 years of age at the time of study entry
- •Adequate bone marrow function
- •Adequate liver function
- •Adequate renal function
- •Adequate performance status
排除标准
- •Subject is pregnant
- •Subject is lactating
- •Renal tumors other than Wilms tumors
研究组 & 干预措施
1
干预措施: Topotecan, Filgrastim (G-CSF), Pegfilgrastim (Drug)
结局指标
主要结局
Response rate (complete and partial response as per RECIST criteria).
时间窗: 5 years
次要结局
未报告次要终点