NCT00003969已完成1 期
A Phase I Pharmacokinetic and Pharmacodynamic Study of 17-Allylamino-17-Demethoxygeldanamycin (17-AAG) (NSC 330507) Via Intravenous Administration in Patients With Advanced Malignancies
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
- 主要终点
- Recommended phase II dose of 17-allylamino-17-demethoxygeldanamycin (17-AAG) at 4 weeks
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase I trial is studying the side effects and best dose of a geldanamycin analogue in treating patients with advanced cancer.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose for a geldanamycin analogue, 17-allylamino-17-demethoxygeldanamycin (AAG), in patients with advanced malignancies.
- Determine the toxic effects and dose-limiting toxicity of AAG in this patient population.
- Determine the safe dose of AAG for a Phase II study.
- Measure the pharmacokinetic and pharmacodynamic profiles of AAG in these patients.
- Assess time to tumor progression and any antitumor activity in patients treated with AAG.
OUTLINE: This is a dose-escalation study.
Patients receive a geldanamycin analogue, 17-allylamino-17-demethoxygeldanamycin (AAG), IV over 15-30 minutes every week. Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of AAG 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically proven malignancies refractory to conventional treatment or for which no standard therapy exists
- •Primary brain tumor or brain metastases allowed if stable symptoms within 2 weeks prior to study and able to give informed consent
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Life expectancy:
- •At least 3 months
- •Hematopoietic:
- •WBC at least 3,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Hemoglobin at least 10.0 g/dL
- •Absolute neutrophil count at least 1,500/mm^3
- •Bilirubin less than 1.0 mg/dL
- •AST and ALT no greater than 2.5 times upper limit of normal if due to liver metastases
- •No chronic liver disease
- •Creatinine less than 1.47 mg/dL OR
- •Creatinine clearance greater than 60 mL/min
- •Cardiovascular:
- •No myocardial infarction within the past 6 months
- •No angina requiring treatment within the past 6 months
- •No uncompensated coronary artery disease by electrocardiogram or physical examination
- •No prior transient ischemic attacks, stroke, or peripheral vascular disease
- •LVEF at least 45%
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 4 weeks after study
- •No allergy to egg products
- •No nonmalignant systemic disease that would increase risk
- •No active uncontrolled infection
- •No diabetes mellitus with evidence of severe peripheral vascular disease or diabetic ulcers
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 4 weeks since prior immunotherapy and recovered
- •Chemotherapy:
- •At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin) and recovered
- •No other concurrent chemotherapy
- •Endocrine therapy:
- •At least 4 weeks since other prior endocrine therapy and recovered
- •Concurrent corticosteroids for symptom control allowed if no change in dose requirement within 2 weeks prior to study
- •Radiotherapy:
- •At least 4 weeks since prior radiotherapy (except for palliative reasons) and recovered
- •Concurrent radiotherapy allowed for control of bone pain or as indicated
- •Not specified
- •No other concurrent investigational treatment
- •No concurrent treatment with drugs interfering with hepatic CYP3A4 metabolism (e.g., grapefruit juice or warfarin)
排除标准
- 未提供
结局指标
主要结局
Recommended phase II dose of 17-allylamino-17-demethoxygeldanamycin (17-AAG) at 4 weeks
次要结局
- Heat shock protein 90 (HSP90) client protein and co-chaperone changes during first course of treatment
- Pharmacokinetic profile of 17-AAG during the first course of treatment
研究者
研究点 (2)
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