Glioblastoma Multiforme Clinical Trial
Official title:
A Phase II Study of Bevacizumab in Combination With Metronomic Temozolomide for Recurrent Malignant Glioma
This is a phase II study of the combination of Avastin and metronomic temozolomide in recurrent malignant glioma patients. The primary objective will be to determine the efficacy of Avastin (bevacizumab) and metronomic temozolomide in malignant glioma patients. The secondary objective will be to determine the safety of Avastin, 10 mg/kg every other week, in combination with metronomic temozolomide in terms of progression-free survival.
This is a phase II trial of the combination of Avastin and metronomic temozolomide in
recurrent WHO grade IV malignant glioma patients. Patients will receive up to 12 cycles of
Avastin and temozolomide and cycles are continuous 28 days. Patients will receive daily
temozolomide at a dose of 50mg/m2 and will receive Avastin every other week at a dose of
10mg/kg. Patients will be required to have a baseline MRI within 2 weeks of starting
treatment and a repeat MRI every 8 weeks. A total of 32 patients will be enrolled at Duke.
Patients with recurrent malignant gliomas have a very poor prognosis, so new therapies are
needed. Given the activity of metronomic temozolomide and the safety and activity of Avastin
against malignant glioma, it is reasonable to study the combination in recurrent malignant
glioma patients.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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