Phase II Study of Bevacizumab (Avastin) and BCNU for Treatment of Relapsed, High Grade Gliomas
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 7
- 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. Drugs used in chemotherapy, such as carmustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with carmustine may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving bevacizumab together with carmustine works in treating patients with relapsed or progressive high-grade glioma.
详细描述
OBJECTIVES:
Primary
- To determine the 6-month progression-free survival of patients with relapsed or progressive high-grade gliomas treated with bevacizumab and carmustine.
Secondary
- To evaluate the radiographic response to this regimen as measured by MRI and PET scan with image fusion.
- To utilize novel brain imaging to differentiate between a radiographic response due to tumor shrinkage and a radiographic response due to decreased vasogenic edema.
- To evaluate the safety and toxicity of this regimen in these patients.
- To evaluate the overall survival of 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed GBM, anaplastic astrocytoma, anaplastic oligoastrocytoma or anaplastic oligodendroglioma.
- •Disease progression (confirmed by MRI, PET or both) after radiation therapy
- •At least 28 days have elapsed since chemotherapy, major surgery or radiation therapy.
- •No other malignancy within 3 years except for non-melanomatous skin cancer or in situ cervical cancer.
- •Karnofsky performance score at least 70
- •Platelet count ≥ 130/mm
- •Absolute neutrophil count ≥ 1500/mm3
- •Calculated creatinine clearance greater than 45 mg/dl
- •AST < 2 times the upper limit of normal
- •Bilirubin < 1.5 times the upper limit of normal
- •Ability to give signed informed consent
- •Patients must be 18 years of age or older.
排除标准
- •Prior intravenous or oral nitrosoureas (BCNU, CCNU) or prior VEGF targeted therapy including bevacizumab. No more than two prior chemotherapy regimens are allowed. Prior or current steroid use is allowed.
- •Evidence of CNS hemorrhage
- •Requirement for therapeutic anticoagulation
- •Any grade 3 or greater hemorrhage within the previous 28 days
- •Active inflammatory bowel disease
- •Inadequately controlled hypertension
- •Any prior history of hypertensive crisis or hypertensive encephalopathy
- •New York Heart Association Grade II or greater congestive heart failure
- •History of myocardial infarction or unstable angina within 6 months prior to study enrollment
- •History of stroke or transient ischemic attack within 6 months prior to study enrollment
- •Significant vascular disease
- •Symptomatic peripheral vascular disease
- •Evidence of bleeding diathesis or coagulopathy
- •Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrollment or anticipation of need for major surgical procedure during the course of the study
- •Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to study enrollment
- •History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment
- •Serious, non-healing wound, ulcer, or bone fracture
- •Proteinuria at screening
- •Pregnant (or lactating). Use of effective means of contraception in subjects of child-bearing potential
- •Prior organ transplantation
- •Known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
- •Known acquired immune deficiency syndrome (AIDS) or HIV positive status
研究组 & 干预措施
Bevacizumab and Carmustine
干预措施: bevacizumab (Drug)
Bevacizumab and Carmustine
干预措施: carmustine (Drug)
结局指标
主要结局
Progression-free Survival
时间窗: Time from first day of treatment to the first observation of disease progression or death due to any cause (up to 7 years).
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
次要结局
- Radiographic Response to Therapy(One year)
- Differentiate a Radiographic Response Due to Tumor Shrinkage From a Radiographic Response Due to Decreased Vasogenic Edema(One year)
- Safety and Toxicity(One year)
- Overall Survival(Time from first day of treatment to time of death due to any cause (up to 7 years).)