NCT00085111已完成1 期
A Phase I Study of Bevacizumab in Refractory Solid Tumors
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Maximum tolerated dose defined based on the dose-limiting toxicities graded according to Common Terminology Criteria for Adverse Events v3.0
研究概览
简要总结
This phase I trial is studying the side effects and best dose of bevacizumab in treating young patients with refractory solid tumors. Monoclonal antibodies, such as bevacizumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
详细描述
PRIMARY OBJECTIVES:
I. To estimate the maximum tolerable dose (MTD) of bevacizumab by dose escalation to a maximum of 15mg/kg, even if MTD is not reached, administered as an intravenous infusion, every 2 weeks to children with refractory solid tumors.
II. To determine the dose-limiting toxicities (DLT) and other toxicities of bevacizumab given on this schedule.
III. To characterize the pharmacokinetic behavior of bevacizumab in children with refractory cancer.
SECONDARY OBJECTIVES:
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
- 1 Year 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed solid tumor at original diagnosis
- •Measurable or evaluable* disease
- •No known curative therapy exists
- •No lymphomas or primary CNS tumors
- •No history or clinical evidence of CNS metastasis by head CT scan
- •Performance status - Karnofsky 50-100% (patients > 10 years of age)
- •Performance status - Lansky 50-100% (patients ≤ 10 years of age)
- •At least 8 weeks
- •Patients without bone marrow involvement:
- •Absolute neutrophil count ≥ 1,000/mm^3
- •Platelet count ≥ 100,000/mm^3 (transfusion independent)
- •Hemoglobin ≥ 8.0 g/dL (RBC transfusion allowed)
- •Patients with bone marrow metastases:
- •Platelet count ≥ 75,000/mm^3 (transfusion independent)
- •Granulocytopenia, anemia, and/or mild thrombocytopenia allowed
- •No known bleeding diathesis or coagulopathy
- •No known thrombophilic condition (e.g., protein S, protein C, or antithrombin III deficiency, Factor V Leiden, Factor II G20210A mutation, homocystinemia, or antiphospholipid antibody syndrome)
- •PT or PTT ≤ 1.2 times upper limit of normal (ULN)
- •ALT ≤ 5 times ULN
- •Bilirubin ≤ 1.5 times ULN
- •Albumin ≥ 2 g/dL
- •Creatinine clearance or radioisotope glomerular filtrationrate ≥ 70 mL/min
- •Creatinine based on age as follows:
- •Creatinine ≤ 0.8 mg/dL (patients ≤ 5 years of age)
- •Creatinine ≤ 1.0 mg/dL (patients 6 to 10 years of age)
- •Creatinine ≤ 1.2 mg/dL (patients 11 to 15 years of age)
- •Creatinine ≤ 1.5 mg/dL (patients > 15 years of age)
- •No proteinuria
- •24-hour urine protein ≤ 500 mg
- •No history of stroke
- •No deep venous or arterial thrombosis within the past 3 months
- •No uncontrolled hypertension
- •Hypertension must be well-controlled with stable doses of medication for at least 2 weeks
- •No history of myocardial infarction
- •No severe or unstable angina
- •No transient ischemic attack within the past 6 months
- •No cerebrovascular accident within the past 6 months
- •No other arterial thromboembolic event within the past 6 months
- •No clinically significant or severe peripheral vascular disease
- •No pulmonary embolism within the past 3 months
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for at least 3 months after study participation
- •No chronic non-healing wound, ulcer, or bone fracture
- •No significant traumatic injury within the past 28 days
- •No uncontrolled seizures
- •No uncontrolled infection
- •No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
- •Recovered from prior immunotherapy
- •More than 1 week since prior growth factors
- 另有 26 项未显示
排除标准
- 未提供
结局指标
主要结局
Maximum tolerated dose defined based on the dose-limiting toxicities graded according to Common Terminology Criteria for Adverse Events v3.0
时间窗: 28 days
次要结局
未报告次要终点
研究者
研究点 (2)
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