A Randomized Phase II Trial of Bevacizumab to Control Brain Radiation Damage
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Number of Participants With Response ( > 25% Reduction in T2 Flair) From Baseline to Evaluation at 6 Weeks Post Treatment
研究概览
简要总结
Bevacizumab may reduce CNS side effects caused by radiation therapy. This randomized phase II trial is studying how well bevacizumab works in reducing CNS side effects in patients who have undergone radiation therapy to the brain for primary brain tumor, meningioma, or head and neck cancer.
详细描述
PRIMARY OBJECTIVE:
I. Determine to what extent bevacizumab can reduce active radiation toxicity to the CNS in patients who have undergone cranial irradiation for primary brain neoplasm, meningioma, or head and neck cancer.
SECONDARY OBJECTIVES:
I. Determine to what extent this drug can reduce dexamethasone dependence in these patients.
II. Determine to what extent this drug can improve neurologic function in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
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
- •No evidence of bleeding diathesis or coagulopathy
- •Fertile patients must use effective contraception during and for >= 2 months after completion of study therapy
- •No diarrhea >= grade 1
- •Histologically confirmed primary brain neoplasm, meningioma, or head and neck cancer [WHO grade 2 or 3 disease--no WHO grade 4 primary brain neoplasms (i.e., glioblastoma or gliosarcoma)]
- •Patients with head and neck cancer must not have any of the following:
- •Evidence of metastatic disease
- •Evidence of tumor invasion to major vessels (e.g., the carotid)
- •History of bleeding related to tumor or radiotherapy during or after completion of radiotherapy
- •Must have undergone cranial irradiation
- •Must have radiographic evidence to support the diagnosis of radiation necrosis and/or surgical biopsy evidence of necrosis without tumor within the past 2 months
- •Must have evidence of progressive neurologic signs or symptoms appropriate to the location of the radiation necrosis
- •No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
- •No significant traumatic injury within the past 28 days
- •No evidence of active CNS hemorrhage
- •Karnofsky performance status 60-100%
- •No clinically significant cardiovascular disease, including any of the following:
- •Inadequately controlled hypertension (i.e., systolic BP > 140 mm Hg and/or diastolic BP > 90 mm Hg despite antihypertensive medication)
- •Large vessel cerebrovascular accident within the past 6 months
- •Myocardial infarction or unstable angina within the past 6 months
- •No clinically significant cardiovascular disease, including any of the following:
- •NYHA class II-IV congestive heart failure
- •Serious or inadequately controlled cardiac arrhythmia
- •Significant vascular disease (e.g., aortic aneurysm or history of aortic dissection)
- •Clinically significant peripheral vascular disease
- •At least 6 months since prior radiotherapy
- •Platelet count > 75,000/mm^3
- •Granulocyte count > 1,500/mm^3
- •Creatinine < 1.0 times ULN
- •AST < 2.5 times ULN
- •Not pregnant or nursing
- •Negative pregnancy test
- •Prior chemotherapy for tumor allowed
- •Prior tyrosine kinase inhibitors of VEGF receptor (VEGFR) allowed
- •More than 28 days since prior and no concurrent major surgical procedure or open biopsy
- •Concurrent dexamethasone allowed provided patient is on a stable dose for >= 1 week prior to study entry
- •Concurrent full-dose anticoagulants (e.g., warfarin) with PT INR > 1.5 allowed provided the following criteria are met:
- •In-range INR (usually between 2 and 3) and patient is on a stable dose of oral anticoagulant for 1 week or on a stable dose of low molecular weight heparin
- •No active bleeding or pathological condition that carries a high risk of bleeding
- •Concurrent full-dose anticoagulants (e.g., warfarin) with PT INR > 1.5 allowed provided the following criteria are met: No evidence of serious or nonhealing wound, ulcer, or bone fracture
- •No concurrent chemotherapy or tyrosine kinase inhibitors of VEGFR
- •No prior bevacizumab
- •More than 7 days since prior core biopsy
- •History of seizures allowed provided the patient is receiving anticonvulsant therapy
- •Hemoglobin >= 9.0 g/dL
- •Bilirubin =< 1.5 times upper limit of normal (ULN)
- •No other concurrent investigational agents
排除标准
- 未提供
研究组 & 干预措施
Arm I
Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.
干预措施: bevacizumab (Drug)
Arm I
Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.
干预措施: magnetic resonance imaging (Procedure)
Arm I
Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.
干预措施: quality-of-life assessment (Procedure)
Arm II
Patients receive placebo IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.
干预措施: placebo (Drug)
Arm II
Patients receive placebo IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.
干预措施: magnetic resonance imaging (Procedure)
Arm II
Patients receive placebo IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.
干预措施: quality-of-life assessment (Procedure)
结局指标
主要结局
Number of Participants With Response ( > 25% Reduction in T2 Flair) From Baseline to Evaluation at 6 Weeks Post Treatment
时间窗: Baseline to 12 weeks
Change in magnetic resonance imaging (MRI) from baseline to evaluation at 6 weeks for participants where MRI changes are based on the size of edema (T2 FLAIR) and Gd-contrast enhancement (lesion diameter and perfusion/dynamic). A 25% reduction in T2 flair volume constitutes a response for study.
次要结局
未报告次要终点