NCT00038025已完成2 期
A Phase II Study of Deoxycoformycin (DCF) in Lymphoid Malignancies
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
- 60
- 试验地点
- 1
- 主要终点
- Number of Participants with Overall Response
研究概览
简要总结
The purpose of this study is to determine the side effects and antitumor response of patients with lymphoid malignancies to Deoxycoformycin (DCF)/Pentostatin.
详细描述
Deoxycoformycin(DCF)/Pentostatin is a T-cell cytotoxic drug with previously reported responses in lymphoid malignancies but larger studies are needed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologic proof of lymphoid malignancy with an expected complete response rate of less than 20 percent OR have failed at least one prior therapy.
- •No chemotherapy within 3 weeks of entry into study and must have recovered from acute toxic effects of prior therapy.
- •Life expectancy of at least 12 weeks.
- •Performance status equal to or less than Zubrod
- •Signed informed consent.
- •Patients with measurable disease.
- •Age at least 16 years.
- •Adequate bone marrow function (unless involvement of bone marrow by lymphoma) defined as AGC greater than 1500 and platelet count greater than 100,
- •Adequate hepatic function with a bilirubin less than or equal to 1.5 mg % and SGPT less than or equal to 4 times the upper limits of normal.
- •Adequate renal function defined as serum creatine less than or equal to 1.5 mg %.
排除标准
- •No serious intercurrent illness.
- •Adequate contraception (if applicable).
- •NO patients with significant cardiac disease, i.e. New York Heart Association (NYHA) class III or IV.
- •NO experimental clinical trial within 3 weeks of study entry.
- •NO patients with active CNS disease.
- •Full recovery from any prior surgical treatment.
- •NO active active infections.
研究组 & 干预措施
Deoxycoformycin (DCF)/Pentostatin
Experimental
干预措施: Deoxycoformycin (DCF) (Drug)
结局指标
主要结局
Number of Participants with Overall Response
时间窗: Baseline and approximately every 3 weeks thereafter
Overall responses (OR) of participants with lymphoid malignancies to Deoxycoformycin (DCF)/Pentostatin defined as Complete Response (CR) and Partial Response (PR).
次要结局
未报告次要终点
研究者
研究点 (1)
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