NCT00045266已完成1 期
An Open-Label, Long Term, Safety, and Tolerability 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 treating patients who have relapsed or refractory solid tumors or non-Hodgkin's lymphoma.
详细描述
OBJECTIVES:
- Determine the long-term safety and tolerability of VEGF Trap in patients with incurable relapsed or refractory solid tumors or non-Hodgkin's lymphoma with stable or responding disease after receiving treatment on protocol MSKCC-01131.
- Determine the biological effect of this therapy on suppressing tumor growth or progression in these patients.
- Determine the steady state concentration of VEGF Trap over time in these patients.
- Determine whether patients develop antibodies to this therapy during extended exposure.
OUTLINE: This is an extension study for patients who showed evidence of stable disease or complete or partial remission after completing treatment on protocol MSKCC-01131.
Patients continue to receive VEGF Trap subcutaneously once weekly for up to an additional 6 months in the absence of unacceptable toxicity. Patients receive treatment at the same dose level as on protocol MSKCC-01131.
Patients are followed at approximately 30 days.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
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 relapsed or refractory solid tumor or non-Hodgkin's lymphoma that has been treated on MSKCC-01131
- •Must have completed participation in protocol MSKCC-01131 through visit 16 and have shown evidence of stable disease or complete or partial remission of tumor burden and no evidence of symptomatic deterioration
- •No adverse event or toxicity which resulted in discontinuation of participation in protocol MSKCC-01131
- •If a patient experienced dose-limiting toxicity, then the patient must have demonstrated the ability to tolerate the same dose or a lower dose prior to entry in this study
- •No known or suspected squamous cell carcinoma of the lung
- •No prior or concurrent new neurological symptoms or CNS (brain or leptomeningeal) metastases during protocol MSKCC-01131
- •PATIENT CHARACTERISTICS:
- •25 and over
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •WBC at least 3,500/mm3
- •Absolute neutrophil count at least 1,500/mm3
- •Platelet count at least 100,000/mm3
- •Hemoglobin at least 9.0 g/dL
- •No 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 severe or uncontrolled renal condition
- •Cardiovascular
- •No severe or uncontrolled cardiovascular condition
- •No severe or uncontrolled pulmonary condition
- •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 condition or adverse social circumstance that would preclude study
- •No other condition that would preclude study
- •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
- •No concurrent epoetin alfa, filgrastim (G-CSF), or sargramostim (GM-CSF)
- •No other concurrent immunotherapy
- •Chemotherapy
- •No concurrent standard chemotherapy
- •Endocrine therapy
- •No concurrent adrenal corticosteroids except low doses as replacement therapy in patients who have previously received suppressive doses or for adrenal insufficiency
- •No concurrent systemic hormonal contraceptive agents
- •Radiotherapy
- •No concurrent radiotherapy
- •Not specified
- •At least 30 days since prior investigational therapy other than VEGF Trap
- •No concurrent standard or other investigational anticancer agents
- •No concurrent herbal supplements ("nutraceuticals")
- 另有 2 项未显示
排除标准
- 未提供
研究者
研究点 (1)
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