Phase I Dose-Escalation Study of the Pharmacokinetic, Safety, Tolerability, and Biologic Activity of huKS-IL-2 Administered Daily as a 1-Hour Intravenous Infusion for Five Consecutive Days for Treatment of Refractory Epithelial Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- EMD Serono
- 试验地点
- 3
研究概览
简要总结
RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Interleukin-2 combined with a monoclonal antibody may be an effective treatment for kidney, bladder, or lung cancer.
PURPOSE: Phase I trial to study the effectiveness of interleukin-2 combined with a monoclonal antibody in treating patients who have kidney, bladder, or lung cancer that has not responded to previous treatment.
详细描述
OBJECTIVES: I. Determine the maximum tolerated dose of KSA-interleukin-2 in patients with refractory epithelial carcinoma. II. Characterize the pharmacokinetics of this drug in these patients. III. Assess the overall toxicity and safety of this drug in these patients. IV. Determine the rate of objective response in patients treated with this drug.
OUTLINE: This is a dose-escalation, multicenter study. Patients receive KSA-interleukin-2 (KSA-IL-2) IV over 1 hour on days 1-5. Treatment repeats every 21 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of KSA-IL-2 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which more than 33% of the patients experience a dose-limiting toxicity. Patients are followed at 30 days.
PROJECTED ACCRUAL: Approximately 12-24 patients will be accrued for this study within 6-12 months.
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