A Phase I Trial of Weekly 17-Allylamino-17 Demethoxygeldanamycin
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- MTD defined as the dose level preceding that at which 2 of 6 patients experience dose-limiting toxicity (DLT) assessed using Common Toxicity Criteria version 2.0
研究概览
简要总结
Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. This phase I trial is studying the side effects and best dose of 17-N-allylamino-17-demethoxygeldanamycin in treating patients with advanced epithelial cancer, malignant lymphoma, or sarcoma
详细描述
PRIMARY OBJECTIVES:
I. Determine the dose-limiting toxicity and maximum tolerated dose of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) in patients with advanced epithelial cancer, malignant lymphoma, or sarcoma.
II. Determine the significant toxic effects associated with this drug in these patients.
III. Determine the response in patients treated with this drug. IV. Determine the pharmacokinetics of 17-AAG and 17AG in these patients.
OUTLINE: This is a dose-escalation study. Patients receive treatment according to 1 of 2 schedules.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Histologically confirmed advanced epithelial cancer, malignant lymphoma, or sarcoma for which no standard curative therapy exists
- •Brain metastases allowed after definitive radiotherapy
- •Performance status - ECOG 0-2
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 1.5 mg/dL
- •SGOT no greater than 2 times normal
- •Creatinine no greater than 1.5 mg/dL
- •Creatinine clearance at least 60 mL/min
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception for at least 1 week before, during, and for at least 2 weeks after study completion
- •No active infection
- •No other serious concurrent condition
- •No prior allergic reaction to egg products
- •At least 4 weeks since prior biologic therapy (regional or systemic)
- •At least 4 weeks since prior chemotherapy
- •See Disease Characteristics
- •At least 4 weeks since prior radiotherapy
排除标准
- 未提供
研究组 & 干预措施
Schedule B (tanespimycin)
Patients receive 17-AAG IV over 1-2 hours twice weekly for 3 weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: tanespimycin (Drug)
Schedule B (tanespimycin)
Patients receive 17-AAG IV over 1-2 hours twice weekly for 3 weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: pharmacological study (Other)
Schedule C (tanespimycin)
Patients receive 17-AAG IV over 1-2 hours twice weekly for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: tanespimycin (Drug)
Schedule C (tanespimycin)
Patients receive 17-AAG IV over 1-2 hours twice weekly for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: pharmacological study (Other)
结局指标
主要结局
MTD defined as the dose level preceding that at which 2 of 6 patients experience dose-limiting toxicity (DLT) assessed using Common Toxicity Criteria version 2.0
时间窗: 4 weeks
次要结局
未报告次要终点