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Bevacizumab and Irinotecan in Treating Patients With Recurrent or Refractory Gliomas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00268359
Recruitment Status : Completed
First Posted : December 22, 2005
Last Update Posted : July 21, 2014
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Duke University

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Biological: bevacizumab Drug: irinotecan hydrochloride Phase 2

Detailed Description:



  • Determine the safety of bevacizumab and irinotecan hydrochloride in patients with recurrent or refractory grade 3 or 4 malignant gliomas.


  • 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bevacizumab in Combination With Irinotecan for Malignant Gliomas
Study Start Date : May 2005
Actual Primary Completion Date : August 2006
Actual Study Completion Date : October 2009

Primary Outcome Measures :
  1. Safety
  2. Activity in terms of progression-free survival

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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)


  • 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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00268359

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United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
National Cancer Institute (NCI)
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Study Chair: James J. Vredenburgh, MD Duke Cancer Institute
Publications of Results:
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Responsible Party: Duke University Identifier: NCT00268359    
Other Study ID Numbers: Pro00004091
CDR0000450832 ( Other Identifier: NCI )
First Posted: December 22, 2005    Key Record Dates
Last Update Posted: July 21, 2014
Last Verified: February 2013
Keywords provided by Duke University:
adult anaplastic astrocytoma
adult anaplastic oligodendroglioma
adult glioblastoma
adult gliosarcoma
recurrent adult brain tumor
adult giant cell glioblastoma
Additional relevant MeSH terms:
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Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action