A Phase II Study of Bevacizumab, Temozolomide and Hypofractionated Radiotherapy for Patients With Newly Diagnosed Malignant Glioma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Number of Participants With Adverse Events
研究概览
简要总结
The purpose of this study is to test the safety of a new plan for treating glioblastoma. The usual first treatment for glioblastoma is to give focused radiation over 6 weeks in combination with a chemotherapy called temozolomide. In this study the radiation will be given over 2 weeks in combination with temozolomide and another drug, bevacizumab, will also be given. Our idea is that this treatment plan may attack both the tumor and the blood vessels feeding the tumor more effectively. This study will look at what effects, good or bad, this approach has on the patient and the tumor.
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
- •Pathologic diagnosis of glioblastoma or grade IV glioma.
- •Tumor volume should be less than 60 cc (approximately 5cm maximum diameter).
- •Age > or = to 18
- •Granulocyte count >1.5 X 10 9/L
- •Platelet count >99 X 10 9/L
- •SGOT < 2.5X upper limit of normal (ULN)
- •Serum creatinine < 2X ULN
- •Bilirubin < 2X ULN
- •All patients must sign written informed consent
排除标准
- •Any prior chemotherapy, radiotherapy and biologic therapy for glioma.
- •Any prior experimental therapy for glioma.
- •Multicentric glioma
- •Other concurrent active malignancy (with the exception of cervical carcinoma in situ or basal cell ca of the skin).
- •Serious medical or psychiatric illness that would in the opinion of the investigator interfere with the prescribed treatment.
- •Pregnant or breast feeding women.
- •Refusal to use effective contraception
- •Inadequately controlled hypertension (defined as systolic blood pressure >150 mmHg and/or diastolic blood pressure > 100 mmHg)
- •Prior history of hypertensive crisis or hypertensive encephalopathy
- •New York Heart Association (NYHA) Grade II or greater congestive heart failure
- •History of myocardial infarction or unstable angina within 12 months prior to Day 1
- •History of stroke or transient ischemic attack
- •Significant vascular disease (e.g., aortic aneurysm, requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Day 1
- •History of hemoptysis (≥ 1/2 teaspoon of bright red blood per episode) within 1 month prior to Day 1
- •Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
- •Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1 of treatment 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 Day 1
- •History of abdominal fistula or gastrointestinal perforation within 6 months prior to Day 1
- •Serious, non-healing wound, active ulcer, or untreated bone fracture
- •Proteinuria as demonstrated by a UPC ratio ≥ 1.0 at screening
- •Known hypersensitivity to any component of bevacizumab
研究组 & 干预措施
RT, with temozolomide and bevacizumab
This treatment regimen is novel in that it delivers the initial course of RT over 2 weeks instead of 6 weeks; also, the addition of bevacizumab during and after RT is a new approach.
干预措施: radiotherapy (RT) in combination with temozolomide and bevacizumab (Other)
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: through study completion, an average of 1 year
Safety assessments and toxicity grading will follow CTCAE Version 4 Grade
次要结局
- Progression Free Survival(through study completion, an average of 1 year)
- Neurocognitive Outcome(through study completion, an average of 1 year)