Status:
COMPLETED
Bevacizumab and Irinotecan in Treating Patients With Recurrent or Refractory Gliomas
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 * Determine the safety of bevacizumab and irinotecan hydrochloride in patients with recurrent or refractory grade 3 or 4 malignant gliomas. Secondary * Determine the activity o...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- 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)
- PATIENT CHARACTERISTICS:
- 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
- PRIOR CONCURRENT THERAPY:
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2009
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT00268359
Start Date
May 1 2005
End Date
October 1 2009
Last Update
July 21 2014
Active Locations (1)
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1
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710