NCT00022048已完成1 期
Safety and Efficacy Trial of Bevacizumab: Anti-VEGF Humanized Monoclonal Antibody (NSC 704865) Therapy for Myelodysplastic Syndrome (MDS)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 3
研究概览
简要总结
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them.
PURPOSE: This phase I/II trial is to see if bevacizumab works in treating patients who have myelodysplastic syndrome.
详细描述
OBJECTIVES:
- Determine the hematologic responses, including changes in hemoglobin levels, neutrophil counts, platelet counts, and percentage of bone marrow blasts, in patients with myelodysplastic syndrome treated with bevacizumab.
- Determine the toxic effects of this regimen in these patients.
- Determine the tolerance in patients treated with this regimen.
- Determine bone marrow cytogenetic responses in patients treated with this regimen.
- Determine bone marrow microvessel density in patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients are stratified according to International Prognostic Scoring System risk status (low (low or intermediate-1) vs high (intermediate-2 or high)).
Patients receive bevacizumab IV over 30-90 minutes. Treatment repeats every 2 weeks for 4-6 months in the absence of disease progression or unacceptable toxicity.
Patients are followed at weeks 1, 3, 5, 7, and 9.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed myelodysplastic syndrome (MDS)
- •Refractory anemia (RA)
- •RA with excess blasts (RAEB)
- •RAEB in transformation
- •RA with ringed sideroblasts
- •Non-proliferative chronic myelomonocytic leukemia (WBC less than 12,000/mm^3)
- •At least 1 of the following cytopenias:
- •Untransfused hemoglobin no greater than 10.0 g/dL and/or red cell transfusion dependent
- •Absolute neutrophil count no greater than 1,800/mm^3 (neutropenia)
- •Platelet count no greater than 100,000/mm^3 (thrombocytopenia)
- •No secondary MDS
- •No known brain metastases
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Karnofsky 60-100%
- •Life expectancy:
- •More than 4 months
- •Hematopoietic:
- •See Disease Characteristics
- •Platelet count at least 20,000/mm^3
- •No hemorrhagic illness within the past 3 weeks
- •No hemolysis
- •No iron deficiency
- •No active blood loss
- •AST and ALT no greater than 2.5 times upper limit of normal (ULN)
- •Bilirubin no greater than 2.0 mg/dL
- •INR less than 2.0
- •PTT less than 1.5 times ULN
- •Creatinine no greater than 2.0 mg/dL
- •No renal dysfunction requiring dialysis within the past 6 months
- •No nephrotic syndrome within the past 6 months
- •Cardiovascular:
- •No myocardial infraction within the past 6 months
- •No severe or unstable angina within the past 6 months
- •No severe peripheral vascular disease (ischemic rest pain, non-healing wound or ulcer, or tissue loss) within the past 6 months
- •No uncontrolled hypertension within the past 6 months
- •No transient ischemic attack within the past 6 months
- •No cerebrovascular accident within the past 6 months
- •No deep venous or arterial thrombosis
- •No coronary artery disease
- •No symptomatic congestive heart failure (New York Heart Association class II-IV heart disease)
- •No cardiac arrhythmia
- •No vascular illness within the past 3 weeks
- •No pulmonary embolism
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No other active malignancy except localized squamous cell or basal cell skin cancer
- 另有 32 项未显示
排除标准
- 未提供
研究者
研究点 (3)
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