NCT00634322终止2 期
Randomized, Blinded, Placebo-Controlled Trial of High Dose Methotrexate With Leucovorin Rescue (HDMTX-LV) With or Without Glucarpidase in Osteosarcoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 7
- 主要终点
- Patients Progressing to Next Chemotherapy Cycle
研究概览
简要总结
The purpose of this study is to demonstrate whether use of glucarpidase facilitates administration of the next cycle of chemotherapy as scheduled and improves safety and tolerability of HDMTX given with LV
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 8 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •osteosarcoma
- •eligible to receive 2 sequential cycles of HDMTX-LV
排除标准
- •prior administration of glucarpidase
- •progression of disease while on previous MTX treatment
研究组 & 干预措施
A
Experimental
HDMTX-LV with glucarpidase
干预措施: glucarpidase (Drug)
B
Active Comparator
HDMTX-LV with placebo
干预措施: leucovorin (Drug)
C
Experimental
compassionate use group to treat or prevent life threatening toxicity in the event of delayed elimination of MTX and/or renal impairment
干预措施: glucarpidase (Drug)
结局指标
主要结局
Patients Progressing to Next Chemotherapy Cycle
时间窗: 1 week after intervention
次要结局
未报告次要终点
研究者
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