Status:
COMPLETED
Bi-weekly Temozolomide Plus Bevacizumab for Adult Patients With Recurrent Glioblastoma Multiforme
Lead Sponsor:
Center for Neurosciences, Tucson
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Recurrent Glioblastoma Multiforme
Recurrent Gliosarcoma
Eligibility:
All Genders
18-83 years
Phase:
PHASE2
Brief Summary
Primary objective - to determine the 6-month progression free survival (PFS) of adult patients with recurrent glioblastoma multiforme/gliosarcoma treated with bi-weekly temozolomide plus (Avastin) bev...
Detailed Description
This is a phase II study of the combination of Avastin and temozolomide for patients with recurrent glioblastoma multiforme. Avastin is administered intravenously at a dose of 10 mg/kg on days 1 and 1...
Eligibility Criteria
Inclusion
- Patients must have histologically confirmed diagnosis of a glioblastoma multiforme/gliosarcoma and:
- Must have completed at least 2 cycles of adjuvant chemotherapy
- Age \> 18 years
- Karnofsky \> 60%
- Hematocrit \> 29%, ANC \> 1,500 cells/dl, platelets \> 125,000 cells/dl
- Serum creatinine \< 1.5 mg/dl, BUN \< 25 mg/dl, serum SGOT and bilirubin \< 1.5 times upper limit of normal
- If on corticosteroids, must be on a stable dose for 1 week prior to entry; if clinically possible, the dose should not be escalated over entry dose level
- Signed informed consent approved by the Institutional Review Board prior to study entry
- If sexually active, will take contraceptive measures for the duration of the treatments
Exclusion
- Prior toxicity grade ≥ 3 with TMZ
- Prior treatment with bevacizumab
- Female patients who are pregnant or breast feeding, or adults of reproductive potential not employing an effective method of birth control
- Concurrent severe and/or uncontrolled medical disease that could compromise participation in the study
- Acute or chronic liver disease (i.e., hepatitis, cirrhosis)
- Confirmed diagnosis of HIV infection
- Have received investigational drugs less than 4 weeks prior to entry on this study or who have not recovered from the toxic effects of such therapy
- Have received chemotherapy within 2 weeks prior (6 weeks for nitrosourea) to entry on this study, or who have not recovered from the toxic effects of such therapy
- Have received biologic, immunotherapeutic or cytostatic agents within 1 week prior to entry on this study or who have not recovered from the toxic effects of such therapy
- Less than 5 years free of another primary malignancy except: if the other primary malignancy is not currently clinically significant
- Have received radiation therapy within 2 weeks prior to entry on this study or who have not recovered from the toxic effects of such therapy.
- Surgical resection of brain tumor within 4 weeks prior to entry on this study or who have not recovered from side effects of such therapy
- Have had any surgery other than resection of a brain tumor within 4 weeks prior to entry on this study or who have not recovered from side effects of such therapy
- Unwilling to or unable to comply with the protocol
- Evidence of tumor progression within on immediate post radiation brain imaging
- Have not received at least 2 cycles of adjuvant chemotherapy
- Life expectancy of less than 12 weeks
- Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study
- Bevacizumab-Specific Exclusions:
- Inadequately controlled hypertension (defined as systolic blood pressure \> 150 mmHg and/or diastolic blood pressure \> 100 mmHg)
- Prior history of hypertensive crisis or hypertensive encephalopathy
- New York Heart Association (NYHA) Grade II or greater congestive heart failure (see Appendix E)
- History of myocardial infarction or unstable angina within 6 months
- History of stroke or transient ischemic attack within 6 months
- Significant vascular disease (e.g., aortic aneurysm, requiring surgical repair or recent peripheral arterial thrombosis) within 6 months
- Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1 or anticipation of need for major surgical procedure during the course of the study
- Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days
- History of abdominal fistula or gastrointestinal perforation within 6 months prior to Day 1
- Serious, non-healing wound, active ulcer, or untreated bone fracture.
- Proteinuria as demonstrated by a UPC ratio greater than or equal to 1.0 at screening
- Known hypersensitivity to any component of bevacizumab
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00883298
Start Date
April 1 2009
End Date
December 1 2014
Last Update
March 30 2017
Active Locations (1)
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1
Center for Neurosciences
Tucson, Arizona, United States, 85718