Status:
COMPLETED
Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI) With Bevacizumab and Irinotecan for Malignant Glioma
Lead Sponsor:
Duke University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Brain and Central Nervous System Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
Detailed Description
OBJECTIVES: Primary * Examine the effect of bevacizumab and irinotecan on vascular permeability and blood flow in patients with recurrent malignant gliomas. Secondary * Determine the reproducibili...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- 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
- PATIENT CHARACTERISTICS:
- 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
- PRIOR CONCURRENT THERAPY:
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00352521
Start Date
April 1 2006
End Date
July 1 2009
Last Update
July 22 2014
Active Locations (1)
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1
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710