NCT00588536已完成2 期
Study of Sequential Administration of Oral 6-Thioguanine After Methotrexate in Patients With Langerhans Cell in Histiocytosis (LCH)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Determine the Incidence of Complete and Partial Response and the Duration of Response in Patients With Langerhans Cell Histiocytosis (LCH) Treated With Sequential Administration of Oral 6-TG After MTX.
研究概览
简要总结
The objective of this study is to determine the incidence of complete and partial response and the duration of response in patients with Langerhans Cell Histiocytosis (LCH) treated with sequential administration of oral 6-Thioguanine (6-TG) after Methotrexate (MTX).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histologic proof of LCH who have multifocal or multisystem disease involvement.
- •Patients must have a life expectancy of at least 8 weeks.
- •All patients must have ECOG performance level rating of-<
- •Patients or their parents (guardian) must sign an informed consent indicating that they are aware of the investigational nature of the study, using commercially available drugs.
- •Patients must have recovered from the toxic effects of prior therapy before entering this study or at least 2 weeks should have elapsed since the end of last course of chemotherapy.
- •Patients must have adequate liver function (bilirubin _< 2.0 mg/dl, SGOT less than 1.5 times normal (unless it is due to disease), adequate renal function (creatinine <_ 1.5 mg/dl, creatinine clearance >_ 60 ml/min/1.73 m2) and normal electrolytes.
- •Patients should have a granulocyte count > 500/uL and a platelet count >_ 100,000/uL (unless due to disease involvement of the bone marrow).
- •Male and female patients of child-bearing age should use effective methods of contraception, if sexually active.
排除标准
- •Patients with active infections or significant medical conditions other than their disease (LCH) shall be excluded.
研究组 & 干预措施
1
Experimental
MTX, 6-TG, Leucovorin
干预措施: Methotrexate (Drug)
1
Experimental
MTX, 6-TG, Leucovorin
干预措施: 6-Thioguanine (Drug)
1
Experimental
MTX, 6-TG, Leucovorin
干预措施: Leucovorin Calcium (Drug)
结局指标
主要结局
Determine the Incidence of Complete and Partial Response and the Duration of Response in Patients With Langerhans Cell Histiocytosis (LCH) Treated With Sequential Administration of Oral 6-TG After MTX.
时间窗: Conclusion of the study
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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