Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI) With Bevacizumab and Irinotecan for Malignant Glioma
Dynamic Contrast-Enhanced Magnetic Resonance Imaging With Bevacizumab in Combination With Irinotecan for Malignant Gliomas
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 block blood flow to the tumor. Drugs used in chemotherapy, such as irinotecan, 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 irinotecan may kill more tumor cells. Diagnostic procedures, such as MRI, may help doctors predict a patient's response to treatment and help plan the best treatment.
PURPOSE: This phase II trial is studying how well giving bevacizumab together with irinotecan works in treating patients with recurrent malignant glioma and how well MRI predicts response to treatment.
研究概览
详细说明
OBJECTIVES:
Primary
- Examine the effect of bevacizumab and irinotecan on vascular permeability and blood flow in patients with recurrent malignant gliomas.
Secondary
- Determine the reproducibility of dynamic contrast-enhanced (DCE-MRI) in malignant gliomas.
- Determine the predictive value of DCE-MRI in patients with recurrent malignant gliomas treated with bevacizumab and irinotecan.
- Describe the activity of the combination of bevacizumab with irinotecan as measured by response rate and progression-free survival.
- Describe the toxicity associated with the administration of bevacizumab with irinotecan.
OUTLINE: Patients receive bevacizumab IV on days 1, 15, and 29 and irinotecan IV on days 2, 15, and 29 during the first 6-week cycle. After the first cycle, the irinotecan and bevacizumab will be given on days 1, 15 and 29. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
Patients also undergo dynamic contrast-enhanced MRI 4 times.
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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North Carolina
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Durham、North Carolina、美国、27710
- Duke Comprehensive Cancer Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
DISEASE CHARACTERISTICS:
Diagnosis of any of the following malignant gliomas:
- Glioblastoma multiforme
- Anaplastic astrocytoma
- Grade 3 or greater WHO astrocytic, oligodendroglial, or mixed glial tumors that were initially diagnosed by histologic examination of a tumor specimen obtained from biopsy or resection
Recurrent disease
- No more than 3 prior recurrences
- Measurable recurrent or residual primary CNS neoplasm on contrast-enhanced MRI or CT scan
- No evidence of CNS hemorrhage on baseline MRI or CT scan
PATIENT CHARACTERISTICS:
- Karnofsky performance status 60-100%
- Hematocrit > 29%
- Absolute neutrophil count > 1,500/mm³
- Platelet count > 125,000/mm³
- Creatinine < 1.5 mg/dL
- SGOT < 1.5 times upper limit of normal (ULN)
- Bilirubin < 1.5 times ULN
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No active infection
- No significant traumatic injury within the past 28 days
PRIOR CONCURRENT THERAPY:
- At least 6 weeks since prior surgical resection
- More than 28 days since prior major surgical procedure or open biopsy
- More than 7 days since prior minor surgical procedure, fine-needle aspirations, or core biopsies
- At least 6 weeks since prior chemotherapy*
- At least 4 weeks since prior radiotherapy*
- No concurrent immunosuppressive agents
- No concurrent therapeutic anticoagulation
- Concurrent corticosteroids allowed if dose has been stable for 1 week prior to study entry NOTE: * Unless there is unequivocal evidence of progressive disease
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Bevacizumab and irinotecan
The bevacizumab will be dosed at 10 mg/kg every 14 days (days 1, 15 and 29) and the irinotecan on days 2, 15, and 29 of the first six week schedule.
The irinotecan dose will depend on whether the patient is on an enzyme-inducing antiepileptic drug (EIAED).
If the patient is on an EIAED, the patient will receive 340 mg/m2 on days 2, 15, and 29 of the first six week schedule.
If the patient is not on an EIAED, the dose of irinotecan will be 125 mg/m2 on days 2, 15, and 29 of the first six week schedule.
After the first cycle, the irinotecan and bevacizumab will be given on days 1, 15 and 29.
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其他名称:
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Correlation of the acute permeability and blood flow response (24-48 hours) with progression-free survival (PFS)
大体时间:1 year
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Assessed by DCE-MRI
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1 year
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次要结果测量
结果测量 |
大体时间 |
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Overall Survival and Tumor Response
大体时间:2 years
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2 years
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Incidence and severity of central nervous system (CNS) hemorrhage and systemic hemorrhage
大体时间:2 years
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2 years
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合作者和调查者
调查人员
- 学习椅:James J. Vredenburgh, MD、Duke Cancer Institute
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- Pro00012387
- DUMC-8053-05-12R0
- CDR0000481476 (其他标识符:NCI)
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