Status:
COMPLETED
Avastin/Temozolomide/Irinotecan for Unresectable/Multifocal Glioblastoma Multiforme
Lead Sponsor:
Katy Peters
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Glioblastoma Multiforme
Gliosarcoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The primary objective of the study is to determine the efficacy of Avastin in combination with temozolomide and irinotecan in terms of response rate. The secondary objectives are to describe the overa...
Eligibility Criteria
Inclusion
- Patients must have histologically confirmed diagnosis of WHO grade IV primary malignant glioma (glioblastoma multiforme or gliosarcoma). Patients will be unresectable or have multifocal disease.
- Age \> or = to 18 years and a life expectancy of \>12 weeks.
- Evidence of measurable primary Central Nervous System (CNS) neoplasm on contrast enhanced MRI.
- An interval of at least one week between prior biopsy or four weeks from surgical resection and enrollment on this protocol.
- Karnofsky \> or = to 60%.
- Hemoglobin \> or = to 9g/dl, absolute neutrophil count (ANC) \> or = to 1,500 cells/microliter, platelets \> or = to 125,000 cells/microliter.
- Serum creatinine ≤ 1.5 mg/dl, serum serum glutamic oxaloacetic transaminase (SGOT) and direct bilirubin ≤ 1.5 times upper limit of normal (if the total bilirubin is greater than or equal to 1.5 x the upper limit of normal, then the direct bilirubin must be ≤ 1.5 x the upper limit of normal).
- Signed informed consent approved by the Institutional Review Board prior to patient entry.
- If sexually active, patients will take contraceptive measures for the duration of the treatments.
Exclusion
- Pregnancy or breast feeding
- Co-medication that may interfere with study results; e.g. immuno-suppressive agents other than corticosteroids.
- Active infection requiring IV antibiotics.
- Treatment with radiotherapy or chemotherapy for a brain tumor, irrespective of the grade of the tumor.
- Evidence of \> grade 1 CNS hemorrhage on baseline MRI or CT scan.
- Avastin-specific
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00979017
Start Date
November 1 2009
End Date
January 1 2013
Last Update
March 19 2014
Active Locations (1)
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1
The Preston Robert Tisch Brain Tumor Center at Duke University Medical Center
Durham, North Carolina, United States, 27710