A Phase II Trial Of Imatinib Mesylate (Gleevec) In Patients With HIV Related Kaposi's Sarcoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 15
- 主要终点
- Proportion of Patients Who Achieve a Clinical Response
研究概览
简要总结
RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth.
PURPOSE: This phase II trial is studying how well imatinib mesylate works in treating patients with HIV-related Kaposi's sarcoma.
详细描述
OBJECTIVES:
Primary
- Determine clinical response in patients with HIV-related Kaposi's sarcoma treated with imatinib mesylate.
Secondary
- Determine the inhibition of platelet-derived growth factor receptors, as determined by immunohistochemistry, in patients treated with this drug.
- Determine cytokine profiles before and after treatment with this drug in these patients.
- Determine the pharmacokinetic profile of this drug and antiretrovirals in these patients.
- Determine mechanisms of primary and secondary resistance to this drug 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 120 Years（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
Imatinib mesylate
Imatinib mesylate (Gleevec) taken 400 mg orally once a day for up to 6 months
干预措施: imatinib mesylate (Drug)
结局指标
主要结局
Proportion of Patients Who Achieve a Clinical Response
时间窗: 20-24 weeks
Clinical response = Complete Response (absence of residual disease) or Partial Response defined as no new lesions (skin or oral), or no new visceral sites of involvement (or the appearance or worsening of tumor-associated edema or effusions); AND 50% or greater decrease in the number of lesions lasting for \>4 weeks; OR Complete flattening of at least 50% of all previously raised lesions OR A 50% decrease in the sum of the products of the largest perpendicular diameters of the marker lesions
次要结局
- Inhibition of Platelet-derived Growth Factor-receptor as Assessed by Immunohistochemistry(12 months)
- Mechanisms of Primary and Secondary Resistance to Imatinib Therapy(12 months)
- Viral Transcription Profile of Kaposi's Sarcoma-associated Herpesvirus(12 months)
- Cytokine Profiles Before and After Imatinib Therapy(12 months)
- Pharmacokinetic Profile of Imatinib and Antiretrovirals(12 months)