Bevacizumab and Irinotecan in Treating Patients With Recurrent or Refractory Gliomas

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Bevacizumab in Combination With Irinotecan for Malignant Gliomas

Conditions
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Brain and Central Nervous System Tumors

Intervention / Treatment
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* Biological: bevacizumab
* Drug: irinotecan hydrochloride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: bevacizumab|nan|
|Drug: irinotecan hydrochloride|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  |  | 
| Activity in terms of progression-free survival |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult glioblastoma, adult gliosarcoma, recurrent adult brain tumor, adult giant cell glioblastoma