Bi-weekly Temozolomide Plus Bevacizumab for Adult Patients With Recurrent Glioblastoma Multiforme

Completed · Phase 2

Conditions studied: Recurrent Glioblastoma Multiforme, Recurrent Gliosarcoma

In brief

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) bevacizumab. Secondary objectives - to determine radiographic response including specialized MRI sequences, safety and overall survival of adult patients with with recurrent glioblastoma multiforme/gliosarcoma treated with bi-weekly temozolomide plus bevacizumab (Avastin). Additionally, tumor DNA (MGMT) analysis as it relates to survival will be evaluated.

Key facts

Study ID

NCT00883298

Run by

Center for Neurosciences, Tucson

People needed

30

Starts

2009-04-01

Expected to finish

2014-12-01

Last updated by the study team

2017-03-30

Who can join

Age: 18 and older, up to 83. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Center for Neurosciences — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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