To determine the safety and efficacy of surgical resection with Gliadel® 3.85% wafer implantation, followed by concomitant limited field radiation therapy and temozolomide, followed by dose dense temozolomide and bevacizumab in subjects undergoing initial surgery for newly-diagnosed high grade glioma.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Between 14 and 28 days after surgery, all subjects will begin a standard course of post-operative limited field radiation therapy to the tumor site and a surrounding margin with concomitant temozolomide at a daily dose of 75 mg/m2 (7 days/week). No later than 45 days after date of completion of radiation therapy, all subjects will begin dose dense temozolomide at dose of 150 mg/m2 on Days 1-7 and 15-21 of a 28 day cycle with concomitant bevacizumab 10mg/kg administered intravenously every other week.
Kentuckiana Cancer Institute
Louisville, Kentucky, United States
RECRUITINGSafety and efficacy of concomitant limited field radiation therapy and temozolomide, followed by dose dense temozolomide and bevacizumab in subjects undergoing initial surgery for newly-diagnosed high grade glioma.
Time frame: First 5 subjects after 6 months.
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