NCT00083213已完成1 期
An Open Label, Sequential Cohort Dose-Escalation Safety, Tolerability and Pharmacokinetic Study of VEGF Trap Administered Intravenously in Patients With Advanced Solid Tumors or Lymphoma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
研究概览
简要总结
RATIONALE: VEGF Trap may stop the growth of solid tumors or non-Hodgkin's lymphoma by stopping blood flow to the tumor.
PURPOSE: This phase I trial is studying the side effects and best dose of intravenous VEGF Trap in treating patients with relapsed or refractory advanced solid tumors or non-Hodgkin's lymphoma.
详细描述
OBJECTIVES:
Primary
- Determine the safety and tolerability of intravenous VEGF Trap in patients with relapsed or refractory advanced solid tumors or non-Hodgkin's lymphoma.
Secondary
- Determine the maximum tolerated intravenous dose of this drug in these patients.
- Determine the pharmacokinetics of this drug in these patients.
- Determine the ability of this drug to bind circulating vascular endothelial growth factor in these patients.
- Determine, preliminarily, the ability of this drug to alter tumor blood flow and tumor vascular permeability in these patients.
- Determine whether antibodies to this drug develop in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed diagnosis of one of the following:
- •Non-Hodgkin's lymphoma
- •Primary or metastatic solid tumor located, by radiography, in at least one of the following sites:
- •Soft tissue
- •Other site that is suitable for delayed contrast-enhanced MRI (e.g., peripheral lung field)
- •Relapsed or refractory (including unresectable) disease
- •Patients with solid tumors must have failed all curative chemotherapeutic regimens
- •Patients with non-Hodgkin's lymphoma must be refractory to at least 2 standard chemotherapeutic regimens and rituximab
- •Not amenable to available conventional therapies AND no standard therapy exists
- •Measurable disease
- •No prior or concurrent CNS metastases (brain or leptomeningeal)
- •No primary intracranial tumor by MRI or CT scan
- •No histologically confirmed squamous cell carcinoma of the lung
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •WBC ≥ 3,500/mm^3
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Hemoglobin ≥ 9.0 g/dL
- •Platelet count ≥ 100,000/mm^3
- •No severe or uncontrolled hematologic condition
- •Bilirubin ≤1.5 times upper limit of normal (ULN)
- •AST and ALT ≤ 2.5 times ULN
- •PT and PTT normal
- •INR normal
- •Hepatitis B surface antigen negative
- •Hepatitis C antibody negative
- •Creatinine ≤ ULN
- •Urine protein/creatinine ratio ≤ 1
- •No severe or uncontrolled renal condition
- •Cardiovascular
- •No clinically significant acute electrocardiographic abnormalities
- •LVEF normal by echocardiogram or MUGA within the past 12 months if there was prior exposure to anthracyclines
- •No untreated or uncontrolled hypertension
- •No blood pressure > 150/100 mm Hg (despite treatment)
- •No isolated systolic hypertension (i.e., systolic blood pressure > 180 mm Hg on at least 2 determinations [on separate days] within the past 3 months)
- •No New York Heart Association class II - IV heart disease
- •No active coronary artery disease requiring acute medical management
- •No angina requiring acute medical management
- •No congestive heart failure requiring acute medical management
- •No ventricular arrhythmia requiring acute medical management
- •No stroke or transient ischemic event within the past 6 months
- •No prior or concurrent peripheral vascular disease
- •No angiographically or ultrasonographically documented arterial or venous occlusive event
- •No symptomatic claudication
- •No symptomatic orthostatic hypotension
- 另有 35 项未显示
排除标准
- 未提供
研究者
研究点 (1)
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