NCT00587873已完成2 期
Sequential Administration of Oral 6-Thioguanine (6-TG) After Methotrexate (MTX) in Patients With Relapsed Hodgkin's Disease (Phase II)
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
- 18
- 试验地点
- 1
- 主要终点
- To determine the incidence of complete and partial response and the duration of response in patients with recurrent or resistant Hodgkin's Disease (HD) treated with sequential administration of oral 6-Thioguanine (6-TG) after IV Methotrexate (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 recurrent or resistant Hodgkin's disease (HD) treated with sequential administration of oral 6-Thioguanin (6-TG) after IV 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 HD who are in relapse and have failed > or = to 2 prior chemotherapy regimens.
- •Patients must have a life expectancy of at least 8 weeks.
- •All patients must have ECOG performance level rating of < or = to
- •Patients or their parents (guardian) must sign an informed consent indicating that they are aware of the investigational nature of the study.
- •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 CT.
- •Patients must have adequate liver function (bilirubin < or = to 2.0 mg/dl, SGOT less than 1.5 times normal (unless it is due to disease), adequate renal function (creatinine < or = to 1.5 mg/dl, creatinine clearance > or = to 60 ml/min/1.73 m2).
- •Patients should have a granulocyte count > or = to 500/gL and a platelet count > or = to 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 malignancy shall be excluded.
- •Patients with HD who had prior MTX or 6-TG should be excluded.
研究组 & 干预措施
1
Experimental
MTX, 6-TG, and Leucovorin combination
干预措施: Methotrexate (Drug)
1
Experimental
MTX, 6-TG, and Leucovorin combination
干预措施: Leucovorin calcium (Drug)
1
Experimental
MTX, 6-TG, and Leucovorin combination
干预措施: 6-Thioguanine (Drug)
结局指标
主要结局
To determine the incidence of complete and partial response and the duration of response in patients with recurrent or resistant Hodgkin's Disease (HD) treated with sequential administration of oral 6-Thioguanine (6-TG) after IV Methotrexate (MTX).
时间窗: Conclusion of the study
次要结局
- Define Toxicity of this sequential drug combination.(Conclusion of study)
研究者
研究点 (1)
Loading locations...
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