ACTRN12610000842066终止1 期
A Phase 1/2 Study to define the objective response rate of Paediatric Patients with Relapsed, Recurrent or Progressive Neuroblastoma to Valproate in Combination with Interferon alpha
Australian and New Zealand Children's Haematology and Oncology Group0 个研究点目标入组 9 人开始时间: 2010年10月6日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 9
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- o limit 至 21 Years(—)
- 性别
- All
入选标准
- •Target tumour is neuroblastoma.
- •Patient must have one of the following:
- •- recurrent disease following aggressive multidrug frontline chemotherapy and autologous transplantation
- •- resistent/refractory disease during aggressive multidrug frontline chemotherapy
- •Patients must have measurable disease
- •Patients must have a performance level of 0, 1, or 2 using Karnofsky scale or Lansky scale
- •Patients must have a life expectancy of greater than or equatl to 8 weeks
- •Patients must have fully recovered from the actue toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering the study
- •Patients must have adequate organ function
排除标准
- •Patients with recurrent or progressive benign lesions without viable malignant neuroblastoma
- •Patients do not meet concomitant medication restrictions
- •For female patients, pregnancy and breast feeding
- •Myeloplastic syndrome
- •Uncontrolled infection
研究者
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