A Phase I Study Of Medi 522 In Patients With Advanced Tumors
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: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.
PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have refractory advanced solid tumors or lymphoma.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose (MTD) of monoclonal antibody anti-alpha V beta 3 integrin (MEDI 522) in patients with refractory advanced solid tumors or lymphoma.
- Determine the safety and tolerability of this drug in these patients.
- Demonstrate significant binding of this drug to its molecular target in vivo in these patients.
- Determine the effects of this drug on angiogenesis in these patients.
- Determine antitumor activity of this drug by measuring tumor size and glucose uptake in these patients.
- Determine the pharmacokinetics of this drug in these patients.
- Determine a recommended phase II dose of this drug based on either the MTD or the optimal biologic response in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive monoclonal antibody anti-alpha V beta 3 integrin (Medi 522) IV over 30 minutes weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 6 patients receive escalating doses of Medi 522 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity.
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 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