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

December 20, 2005
December 22, 2005
July 21, 2014
May 2005
August 2006   (Final data collection date for primary outcome measure)
  • Safety
  • Activity in terms of progression-free survival
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Complete list of historical versions of study NCT00268359 on Archive Site
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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.



  • 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.

Phase 2
Masking: None (Open Label)
Primary Purpose: Treatment
Brain and Central Nervous System Tumors
  • Biological: bevacizumab
  • Drug: irinotecan hydrochloride
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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October 2009
August 2006   (Final data collection date for primary outcome measure)


  • 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
CDR0000450832 ( Other Identifier: NCI )
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Duke University
Duke University
National Cancer Institute (NCI)
Study Chair: James J. Vredenburgh, MD Duke Cancer Institute
Duke University
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP