NCT00082823已完成1 期
An Open-Label, Long-Term, Safety and Tolerability 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
- 3
研究概览
简要总结
RATIONALE: Intravenous VEGF Trap may stop the growth of solid tumors or non-Hodgkin's lymphoma by stopping blood flow to the cancer.
PURPOSE: This phase I trial is studying the side effects of 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 steady-state pharmacokinetics of this drug in these patients.
- Determine the ability of this drug to bind circulating vascular endothelial growth factor in these patients.
- Determine whether antibodies to this drug develop in these patients.
- Determine, preliminarily, the ability of repeated doses of this drug to alter tumor growth and vascular permeability 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 non-Hodgkin's lymphoma OR primary or metastatic solid tumor located in at least one of the following sites:
- •Soft tissue
- •Other site that is suitable for delayed contrast-enhancing MRI
- •Relapsed or refractory disease
- •Failed all conventional therapeutic options AND not amenable to existing therapeutic options
- •Must have completed the active phase (through study visit 9) of MSKCC-03137 (VGFT-ST-0202) without experiencing dose-limiting toxicity
- •No prior or concurrent CNS metastases (brain or leptomeningeal)
- •No new neurological symptoms during treatment on MSKCC-03137 (VGFT-ST-0202)
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Not specified
- •Life expectancy
- •Not specified
- •Hematopoietic
- •No severe or uncontrolled hematologic condition
- •Not specified
- •No severe or uncontrolled renal condition
- •Cardiovascular
- •No severe or uncontrolled cardiovascular condition
- •No severe or uncontrolled pulmonary condition
- •No severe or uncontrolled gastrointestinal, immunologic, or musculoskeletal condition
- •No other medical or psychiatric condition or adverse social circumstance that would preclude study participation
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective double-barrier contraception during and for 3 months after study treatment
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No concurrent epoetin alfa, filgrastim (G-CSF), or sargramostim (GM-CSF)
- •Chemotherapy
- •Not specified
- •Endocrine therapy
- •No concurrent adrenal corticosteroids, except low-dose replacement therapy
- •No concurrent systemic hormonal contraceptive agents
- •Radiotherapy
- •Not specified
- •Not specified
- •No concurrent non-steroidal anti-inflammatory drugs, including cyclo-oxygenase-2 (COX-2) inhibitors
- •No concurrent anticoagulant or antiplatelet drugs, including warfarin, heparin, or aspirin
- •Concurrent low-dose (i.e., 1 mg) warfarin for maintaining patency of venous access devices allowed
- •No other concurrent standard or investigational agents for this malignancy
排除标准
- 未提供
研究者
研究点 (3)
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