NCT00036946已完成1 期
An Open-Label, Sequential Cohort Dose-Escalation Safety, Tolerability And Pharmacokinetic Study Of VEGF Trap In Patients With Incurable, Relapsed Or Refractory Solid Tumors Or Lymphoma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 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 cancer.
PURPOSE: Phase I trial to study the effectiveness of VEGF Trap in patients who have relapsed or refractory solid tumors or non-Hodgkin's lymphoma.
详细描述
OBJECTIVES:
- Determine the safety and tolerability of VEGF Trap in patients with incurable relapsed or refractory solid tumors or non-Hodgkin's lymphoma.
- Determine the maximum tolerated dose of this drug in these patients.
- Determine the pharmacokinetics of this drug in these patients.
- Evaluate the ability of this drug to bind and inactivate circulating vascular endothelial growth factor (VEGF) in these patients.
- Determine the dosing regimen that is optimal for neutralization of circulating VEGF in these patients.
- Determine whether antibodies to this drug develop in these patients.
- Assess, preliminarily, the ability of this drug to alter tumor vascular permeability and tumor growth in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive VEGF Trap subcutaneously once daily on days 1, 29, 36, 43, 50, 57, and 64 in the absence of disease progression or unacceptable toxicity.
Cohorts of 1-6 patients receive escalating doses of VEGF Trap until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 5 additional patients are treated at the MTD.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 25 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 incurable primary or metastatic solid tumor or non-Hodgkin's lymphoma
- •Relapsed after or is refractory (e.g., unresectable) to at least 2 standard chemotherapy regimens and rituximab
- •No standard curative surgery, chemotherapy, immunotherapy, other antitumor therapy, or radiotherapy options exist
- •No known or suspected squamous cell carcinoma of the lung
- •No prior or concurrent CNS (brain or leptomeningeal) metastases
- •No prior or concurrent primary intracranial tumor by MRI or CT scan
- •PATIENT CHARACTERISTICS:
- •25 and over
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •WBC at least 3,500/mm^3
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Hemoglobin at least 9.0 g/dL
- •No other severe or uncontrolled hematologic condition
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •AST and ALT no greater than 2 times ULN
- •Alkaline phosphatase no greater than 2 times ULN
- •PT, PTT, and INR normal
- •Creatinine no greater than ULN
- •No 1+ or greater proteinuria
- •No other severe or uncontrolled renal condition
- •Cardiovascular:
- •Electrocardiogram normal
- •LVEF normal by echocardiogram or MUGA scan within the past 12 months or since completion of prior anthracycline
- •No severe or uncontrolled cardiovascular condition
- •No New York Heart Association class III or IV heart disease
- •No active coronary artery disease, angina, congestive heart failure, or arrhythmia
- •No myocardial infarction within the past 6 months
- •No prior or concurrent peripheral vascular disease, including:
- •Angiographically or ultrasonographically documented arterial or venous occlusive event
- •Symptomatic claudication
- •No untreated or uncontrolled hypertension
- •No treated blood pressure more than 160/100 mm Hg on at least 3 repeated determinations on separate days within the past 6 weeks
- •No symptomatic orthostatic hypotension
- •No severe or uncontrolled pulmonary condition
- •No pulmonary embolism
- •No prior hypersensitivity reactions to any recombinant proteins (e.g., VEGF Trap)
- •No severe or uncontrolled gastrointestinal, immunological, or musculoskeletal condition
- •No severe or uncontrolled psychiatric or adverse social circumstance that would preclude study
- •No active infection requiring antibiotics
- •HIV negative
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective double-barrier contraception during and for at least 3 months after study
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- 另有 22 项未显示
排除标准
- 未提供
研究者
研究点 (1)
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