NCT00427414终止1 期
Pilot Study of Viral Load and Transcription in Kaposi's Sarcoma Patients Treated With Liposomal Anthracyclines
AIDS Malignancy Consortium3 个研究点 分布在 2 个国家目标入组 14 人开始时间: 2008年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 14
- 试验地点
- 3
- 主要终点
- Effect of liposomal daunorubicin citrate on Kaposi's sarcoma-associated herpes virus (KSHV) viral gene expression in tumors
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as liposomal daunorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This clinical trial is studying how well liposomal daunorubicin works in treating patients with HIV-related Kaposi's sarcoma.
详细描述
OBJECTIVES:
Primary
- Determine the effect of liposomal daunorubicin citrate on Kaposi's sarcoma-associated herpes virus (KSHV) viral gene expression in tumors of patients with HIV-related Kaposi's sarcoma.
Secondary
- Determine the effect of this drug on KSHV viral gene expression in peripheral blood mononuclear cells.
- Determine the effect of this drug on KSHV viral load in plasma.
- Correlate viral load with viral gene expression and/or tumor regression in these patients.
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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
liposomal daunorubicin citrate
Experimental
40 mg/m2 Days 1 and 15 every 28 days x 3 cycles
干预措施: liposomal daunorubicin citrate (Drug)
结局指标
主要结局
Effect of liposomal daunorubicin citrate on Kaposi's sarcoma-associated herpes virus (KSHV) viral gene expression in tumors
时间窗: 24-48 hours after the first treatment
次要结局
- Effect of treatment on KSHV viral gene expression in peripheral blood mononuclear cells(24-48 hours after treatment on Day 1/cycle 1, Day 8/cycle 1, and Day 29/cycle 3)
- Effect of treatment on KSHV viral load in plasma(24-48 hours after treatment on Day 1/cycle 1, Day 8/cycle 1, and Day 29/cycle 3)
研究者
研究点 (3)
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