NCT00853021已完成2 期
Phase II Open Label Trial of rIL-2 and Bevacizumab Combination in Patients With Metastatic Clear Cell Renal Carcinoma
Jorge A. Garcia, MD1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2005年12月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Progression Free Survival
研究概览
简要总结
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Biological therapies, such as aldesleukin, may stimulate the immune system in different ways and stop tumor cells from growing. Giving bevacizumab together with aldesleukin may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving bevacizumab together with aldesleukin works in treating patients with metastatic clear cell carcinoma of the kidney.
详细描述
OBJECTIVES:
Primary
- To evaluate the effect of the combination of bevacizumab and aldesleukin on progression-free survival of patients with good- or intermediate-risk metastatic clear cell renal cell carcinoma.
Secondary
- To determine the objective response rate in patients receiving this regimen.
- To determine the time to progression in patients receiving this regimen.
- To evaluate immunomodulatory effects of this regimen in patients
- To evaluate the toxicity of this regimen 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 or cytologically confirmed renal cell carcinoma (RCC) of clear cell histology with or without sarcomatoid features
- •Metastatic disease
- •No non-clear cell RCC (i.e., papillary, collecting-duct, or chromophobe)
- •Good- or intermediate-risk category as defined by having ≤ 2 of the following factors:
- •No prior nephrectomy
- •Karnofsky performance status < 80%
- •Hemoglobin < 12 g/dL
- •Corrected calcium > 10.0 mg/dL
- •LDH > 1.5 times upper limit of normal (ULN)
- •Must have undergone a nephrectomy at least 28 days ago
- •Measurable or evaluable disease by RECIST
- •No significant effusions and/or ascites
- •No prior or concurrent brain or CNS metastasis
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-1
- •Life expectancy of ≥ 3 months
- •WBC ≥ 3,000/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Hemoglobin ≥ 9.5 g/dL
- •Creatinine ≤ 2.0 mg/dL
- •Total bilirubin ≤ 1.5 mg/dL
- •AST ≤ 5.0 times ULN
- •Alkaline phosphatase ≤ 2.5 times ULN (≤ 10 times ULN with bone metastasis)
- •Calcium ≤ 12 mg/dL
- •Urine protein:creatinine ratio ≤ 1.0
- •INR ≤ 1.5 (unless receiving warfarin therapy)
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No uncontrolled seizure disorder
- •No known HIV positivity
- •No local or systemic infections requiring IV antibiotics within the past 28 days
- •No significant traumatic injury in the past 28 days
- •No serious non-healing wound, ulcer, or acute bone fracture
- •No evidence of bleeding diathesis or coagulopathy
- •No other malignancy except basal cell or squamous cell carcinoma of the skin, carcinoma in-situ of the uterine cervix, or any malignancy treated with curative intent and in complete remission for > 3 years
- •No history of serious systemic or severe cardiovascular disease, including any of the following:
- •Arterial thromboembolic event (including transient ischemic attack)
- •Cerebrovascular accident
- •Unstable angina
- •Myocardial infarction within the past 6 months
- •Uncontrolled hypertension (BP > 160/110 mm Hg on medication)
- •Uncontrolled cardiac arrhythmia
- •Congestive heart failure
- •Angina pectoris
- •NYHA class III-IV cardiovascular disease
- •Peripheral vascular disease ≥ grade II
- •No history of abdominal fistula and/or bowel or gastric perforation within the past 6 months
- •No history of other diseases, metabolic dysfunction, or physical or laboratory examination findings giving reasonable suspicion of a disease or condition that contraindicate the use of investigational drugs, or that might affect the interpretation of study results, or that render patient at high-risk for treatment complications
- 另有 10 项未显示
排除标准
- 未提供
研究组 & 干预措施
Bevacizumab and Aldesleukin
Experimental
干预措施: bevacizumab (Biological)
Bevacizumab and Aldesleukin
Experimental
干预措施: aldesleukin (Biological)
结局指标
主要结局
Progression Free Survival
时间窗: From baseline (day -14) to disease progression (reported at 2 years)
Progression free survival is defined as the time between registration and progression of disease as defined by the RECIST criteria where there is a 20% increase in the diameter of the tumor and at least a 5mm absolute increase in diameter.
次要结局
- Objective Response Rate (Complete and Partial Response)(4 weeks after end of treatment)
- Percentage of Patients With Constitutional Adverse Events(From start of treatment to 30 days after treatment)
- Percentage of Patients With Neutropenia(From start of treatment to 30 days after treatment)
研究者
Jorge A. Garcia, MD
Principal Investigator
Case Comprehensive Cancer Center
研究点 (1)
Loading locations...
相似试验
Unknown
2 期
Bevacizumab, Hormone Therapy, and Radiation Therapy in Treating Patients With Locally Advanced Prostate CancerProstate CancerNCT00348998Virginia Mason Hospital/Medical Center18
已完成
2 期
Bevacizumab and Sorafenib in Treating Patients With Recurrent Glioblastoma MultiformeBrain and Central Nervous System TumorsNCT00621686Alliance for Clinical Trials in Oncology54
已完成
2 期
Bevacizumab, Cisplatin, Etoposide, and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung CancerLung CancerNCT00387699Eastern Cooperative Oncology Group79
已完成
2 期
Bevacizumab, Temozolomide, and External Beam Radiation Therapy as First-Line Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or GliosarcomaBrain and Central Nervous System TumorsNCT01013285Jonsson Comprehensive Cancer Center70
已完成
2 期
Bevacizumab in Treating Patients With Recurrent or Progressive MeningiomasAdult Grade I MeningiomaAdult Papillary MeningiomaNeurofibromatosis Type 2Adult EpendymomaRecurrent Adult Brain TumorAdult Meningeal HemangiopericytomaNeurofibromatosis Type 1Acoustic SchwannomaAdult Anaplastic MeningiomaAdult Grade II MeningiomaNCT01125046Northwestern University50