Imatinib Mesylate and Temozolomide in Treating Patients With 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 oligodendroglioma, adult giant cell glioblastoma, adult gliosarcoma, adult mixed glioma, adult anaplastic astrocytoma, recurrent adult brain tumor, adult glioblastoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed malignant glioma Any of the following subtypes: Glioblastoma multiforme Gliosarcoma Anaplastic astrocytoma Anaplastic oligodendroglioma Anaplastic oligoastrocytoma Previous histologic diagnosis of a lower grade of glioma allowed if there is histologic evidence of progression to a diagnosis of malignant glioma Multifocal disease allowed Must have undergone prior conventional external-beam radiation therapy Stable disease, disease recurrence, or relapsed disease Must not have received any systemic therapy for this recurrence or relapse No prior progressive disease No central/systemic fluid collections (pericardial effusion, pulmonary effusion, ascites) ≥ grade 2 No evidence of intratumor hemorrhage on pretreatment diagnostic imaging, except for stable post-operative grade 1 hemorrhage PATIENT CHARACTERISTICS: Karnofsky performance status 70-100% Absolute neutrophil count > 1,500/mm³ Hemoglobin > 9 g/dL Platelet count > 100,000/mm³ AST and ALT < 2.5 times upper limit of normal (ULN) Bilirubin < 1.5 times ULN Creatinine < 1.5 times ULN No chronic renal disease No active uncontrolled infection No uncontrolled diabetes No excessive risk of bleeding, as defined by occurrence of any of the following: Stroke within the past 6 months History of CNS or intraocular bleed Septic endocarditis No history of labile hypertension No congestive heart failure No poorly controlled hypertension No myocardial infarction within the past 6 months No history of poor compliance with antihypertensive regimen No other severe and/or uncontrolled medical disease that would preclude study participation No peripheral edema ≥ grade 2 No gastrointestinal bleeding No gross hematuria No other active systemic bleeding Patients must not have experienced toxicity ≥ grade 3 with prior treatment with either temozolomide or imatinib mesylate No other primary malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix or other cancer not currently clinically significant nor requiring active interventions PRIOR CONCURRENT THERAPY: See Disease Characteristics Recovered from all prior therapy Prior surgical resection(s) allowed At least 2 weeks since prior surgery At least 2 weeks since prior chemotherapy (6 weeks for nitrosoureas) At least 2 weeks since prior external-beam radiotherapy At least 2 weeks since prior investigational drugs More than 1 week since prior biologic, immunotherapeutic, or cytostatic agents No concurrent warfarin
Sites / Locations
- Duke Cancer Institute