JPRN-UMIN000001037已完成1 期
Phase I/II Study of Topotecan and Ifosfamide in Pediatric Patients with Relapsed or Refractory Solid Tumors - TI chemotherapy for Relapsed Pediatric Solid Tumor pI/II
Group for "making evidence for the drugs which are available in clinical practice in Europe and USA but not available in Japan"0 个研究点目标入组 40 人开始时间: 2008年2月16日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
Recommended dose of topotecan with ifosfamide 1.2g/m2/d was determined to be level0. Currently phaseII is ongoing.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 1years-old 至 30years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1. Active double cancer (synchronous double cancer and metachronous double cancer within 5 disease-free years), excluding carcinoma in situ (lesions equal to intraepithelial or intramucosal cancer) judged to have been cured with local treatment 2. Active infection requiring systemic medication 3. abnormality in electrocardiogram tested within 28 days, requiring intervention 4. respiratory or heart disorder requiring oxygen supply, except from malignant pleural effusion 5. abnormality in electroencephalogram and requiring medication for neuropsychological signs or symptoms 6. Women during pregnancy or breast-feeding 7. Psychosis 8. Systemic steroids medication
研究者
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