NCT00019188已完成1 期
Phase I/II Pilot Study of Interleukin-12 in Patients With AIDS-Associated Kaposi's Sarcoma
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill their tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of interleukin-12 in treating patients with AIDS -related Kaposi's sarcoma.
详细描述
OBJECTIVES: I. Determine the maximum tolerated dose of interleukin-12 (IL-12) in patients with AIDS-associated Kaposi's sarcoma.
II. Determine the antitumor activity of IL-12 in these patients. III. Determine the effect of IL-12 on angiogenic factors, including basic fibroblast growth factor, vascular endothelial growth factor, and interferon-inducible protein 10 in these patients.
IV. Determine the immunologic and virologic effects of IL-12 in these patients.
PROTOCOL OUTLINE: This is a dose escalation study. Patients receive interleukin-12 (IL-12) subcutaneously twice a week (at least 3 days apart) for 6 months. Patients with stable or better disease continue IL-12 treatment in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of IL-12 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity. Ten additional patients are treated at the MTD.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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
研究者
研究点 (2)
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