Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI) With Bevacizumab and Irinotecan for Malignant Glioma
Brain and Central Nervous System Tumors
About this trial
This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring adult anaplastic astrocytoma, adult mixed glioma, adult giant cell glioblastoma, adult gliosarcoma, recurrent adult brain tumor, adult glioblastoma, adult anaplastic ependymoma, adult anaplastic oligodendroglioma, adult pineal gland astrocytoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of any of the following malignant gliomas: Glioblastoma multiforme Anaplastic astrocytoma Grade 3 or greater WHO astrocytic, oligodendroglial, or mixed glial tumors that were initially diagnosed by histologic examination of a tumor specimen obtained from biopsy or resection Recurrent disease No more than 3 prior recurrences Measurable recurrent or residual primary CNS neoplasm on contrast-enhanced MRI or CT scan No evidence of CNS hemorrhage on baseline MRI or CT scan PATIENT CHARACTERISTICS: Karnofsky performance status 60-100% Hematocrit > 29% Absolute neutrophil count > 1,500/mm³ Platelet count > 125,000/mm³ Creatinine < 1.5 mg/dL SGOT < 1.5 times upper limit of normal (ULN) Bilirubin < 1.5 times ULN Not pregnant or nursing Fertile patients must use effective contraception No active infection No significant traumatic injury within the past 28 days PRIOR CONCURRENT THERAPY: At least 6 weeks since prior surgical resection More than 28 days since prior major surgical procedure or open biopsy More than 7 days since prior minor surgical procedure, fine-needle aspirations, or core biopsies At least 6 weeks since prior chemotherapy* At least 4 weeks since prior radiotherapy* No concurrent immunosuppressive agents No concurrent therapeutic anticoagulation Concurrent corticosteroids allowed if dose has been stable for 1 week prior to study entry NOTE: * Unless there is unequivocal evidence of progressive disease
Sites / Locations
- Duke Comprehensive Cancer Center
Arms of the Study
Arm 1
Experimental
Bevacizumab and irinotecan
The bevacizumab will be dosed at 10 mg/kg every 14 days (days 1, 15 and 29) and the irinotecan on days 2, 15, and 29 of the first six week schedule. The irinotecan dose will depend on whether the patient is on an enzyme-inducing antiepileptic drug (EIAED). If the patient is on an EIAED, the patient will receive 340 mg/m2 on days 2, 15, and 29 of the first six week schedule. If the patient is not on an EIAED, the dose of irinotecan will be 125 mg/m2 on days 2, 15, and 29 of the first six week schedule. After the first cycle, the irinotecan and bevacizumab will be given on days 1, 15 and 29.