Bevacizumab and Irinotecan in Treating Patients With Recurrent or Refractory Gliomas
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 stop the growth of tumor cells by blocking 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 tumors cells.
PURPOSE: This phase II trial is studying the side effects of bevacizumab and how well giving bevacizumab together with irinotecan works in treating patients with recurrent or refractory gliomas.
研究概览
详细说明
OBJECTIVES:
Primary
- Determine the safety of bevacizumab and irinotecan hydrochloride in patients with recurrent or refractory grade 3 or 4 malignant gliomas.
Secondary
- Determine the activity of this regimen, in terms of progression-free survival, in these patients.
OUTLINE: Patients receive bevacizumab and irinotecan hydrochloride every 2 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 68 patients will be accrued for this study.
研究类型
注册 (预期的)
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:
Histologically confirmed primary grade 3 or 4 malignant glioma of 1 of the following types:
- Glioblastoma multiforme
- Gliosarcoma
- Anaplastic astrocytoma
- Anaplastic oligodendroglioma
- Patients with recurrent disease whose original diagnostic pathology confirmed malignant glioma will not need re-biopsy
- Measurable recurrent or residual primary disease on contrast-enhanced MRI or CT scan
- Failed ≥ 1 prior chemotherapy regimen (with or without radiotherapy)
PATIENT CHARACTERISTICS:
- Karnofsky performance status 60-100%
- Hematocrit > 29%
- Absolute neutrophil count > 1,500/mm^3
- Platelets > 125,000/mm^3
- Serum SGOT and bilirubin < 1.5 times upper limit of normal
- Creatinine < 1.5 mg/dL
- Urine protein:creatinine ratio ≤ 1.0
- Blood pressure ≤ 150/100 mmHg
- No unstable angina
- No New York Heart Association class II or greater congestive heart failure
- No myocardial infarction within the past 6 months
- No stroke within the past 6 months
- No clinically significant peripheral vascular disease
- No evidence of bleeding diathesis or coagulopathy
- No significant traumatic injury within the past 28 days
PRIOR CONCURRENT THERAPY:
- At least 4 weeks must have elapsed since prior chemotherapy or radiotherapy unless there is unequivocal evidence of tumor progression
- At least 6 weeks since prior surgical resection
- No previous major surgical procedures or open biopsies within 28 days prior to study entry
- No previous minor surgical procedures, fine needle aspirations, or core biopsies within 7 days prior to study entry
- No anticipated need for major surgical procedures during the course of the study
- No concurrent aspirin, non-steroidal anti-inflammatory drugs, or clopidogrel
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 屏蔽:无(打开标签)
研究衡量的是什么?
主要结果指标
结果测量 |
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安全
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Activity in terms of progression-free survival
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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
出版物和有用的链接
一般刊物
- Desjardins A, Reardon DA, Herndon JE 2nd, Marcello J, Quinn JA, Rich JN, Sathornsumetee S, Gururangan S, Sampson J, Bailey L, Bigner DD, Friedman AH, Friedman HS, Vredenburgh JJ. Bevacizumab plus irinotecan in recurrent WHO grade 3 malignant gliomas. Clin Cancer Res. 2008 Nov 1;14(21):7068-73. doi: 10.1158/1078-0432.CCR-08-0260.
- Sathornsumetee S, Cao Y, Marcello JE, Herndon JE 2nd, McLendon RE, Desjardins A, Friedman HS, Dewhirst MW, Vredenburgh JJ, Rich JN. Tumor angiogenic and hypoxic profiles predict radiographic response and survival in malignant astrocytoma patients treated with bevacizumab and irinotecan. J Clin Oncol. 2008 Jan 10;26(2):271-8. doi: 10.1200/JCO.2007.13.3652.
- Vredenburgh JJ, Desjardins A, Herndon JE 2nd, Dowell JM, Reardon DA, Quinn JA, Rich JN, Sathornsumetee S, Gururangan S, Wagner M, Bigner DD, Friedman AH, Friedman HS. Phase II trial of bevacizumab and irinotecan in recurrent malignant glioma. Clin Cancer Res. 2007 Feb 15;13(4):1253-9. doi: 10.1158/1078-0432.CCR-06-2309.
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
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