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Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI) With Bevacizumab and Irinotecan for Malignant Glioma

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: NCT00352521
Recruitment Status : Completed
First Posted : July 14, 2006
Last Update Posted : July 22, 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 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.

Condition or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Drug: bevacizumab Drug: irinotecan Procedure: dynamic contrast-enhanced magnetic resonance imaging Phase 2

Detailed Description:



  • Examine the effect of bevacizumab and irinotecan on vascular permeability and blood flow in patients with recurrent malignant gliomas.


  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dynamic Contrast-Enhanced Magnetic Resonance Imaging With Bevacizumab in Combination With Irinotecan for Malignant Gliomas
Study Start Date : April 2006
Actual Primary Completion Date : December 2006
Actual Study Completion Date : July 2009

Arm Intervention/treatment
Experimental: 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.
Drug: bevacizumab
Other Name: Avastin

Drug: irinotecan
Other Name: Camptosar

Procedure: dynamic contrast-enhanced magnetic resonance imaging

Primary Outcome Measures :
  1. Correlation of the acute permeability and blood flow response (24-48 hours) with progression-free survival (PFS) [ Time Frame: 1 year ]
    Assessed by DCE-MRI

Secondary Outcome Measures :
  1. Overall Survival and Tumor Response [ Time Frame: 2 years ]
  2. Incidence and severity of central nervous system (CNS) hemorrhage and systemic hemorrhage [ Time Frame: 2 years ]

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


  • 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


  • 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


  • 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

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): NCT00352521

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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
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Responsible Party: Duke University Identifier: NCT00352521    
Other Study ID Numbers: Pro00012387
CDR0000481476 ( Other Identifier: NCI )
First Posted: July 14, 2006    Key Record Dates
Last Update Posted: July 22, 2014
Last Verified: February 2013
Keywords provided by Duke University:
adult anaplastic astrocytoma
adult mixed glioma
adult giant cell glioblastoma
adult gliosarcoma
recurrent adult brain tumor
adult glioblastoma
adult anaplastic ependymoma
adult anaplastic oligodendroglioma
adult pineal gland astrocytoma
Additional relevant MeSH terms:
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Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
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