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Dynamic Contrast-Enhanced Magnetic Resonance Imaging With Bevacizumab in Combination With Irinotecan for Malignant Gliomas

Phase 2
18 Years
Not Enrolling
Brain and Central Nervous System Tumors

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Trial Information

Dynamic Contrast-Enhanced Magnetic Resonance Imaging With Bevacizumab in Combination With Irinotecan for Malignant Gliomas



- 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

- 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

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.

Inclusion Criteria


- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Correlation of the acute permeability and blood flow response (24-48 hours) with progression-free survival (PFS)

Outcome Description:

Assessed by DCE-MRI

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

James J. Vredenburgh, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Duke Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

April 2006

Completion Date:

July 2009

Related Keywords:

  • Brain and Central Nervous System Tumors
  • 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
  • Glioma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms



Duke Comprehensive Cancer Center Durham, North Carolina  27710