Recurrent Glioblastoma Multiforme Clinical Trial
Official title:
Phase II Study of Bi-Weekly Temozolomide Plus Bevacizumab for Adult Patients With Recurrent Glioblastoma Multiforme
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.
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 15 every 28 days and temozolomide is administered at a dose of 100 mg/m2 on days 1-5 and 15-19 every 28 days (one cycle). Patients will have a baseline MRI, an MRI scan after the first cycle and every other cycle after that. If there is no evidence of disease progression or unacceptable toxicity, patients will receive one year of therapy. If there is evidence of added benefit (eg: tumor regression), patients can stay on treatment longer than one year, per investigator discretion. ;
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