Imatinib Mesylate and Hydroxyurea in Treating Patients With Recurrent or Progressive Meningioma
Glioblastoma, Gliosarcoma
About this trial
This is an interventional treatment trial for Glioblastoma focused on measuring adult grade I meningioma, adult grade II meningioma, adult grade III meningioma, adult papillary meningioma, adult anaplastic meningioma, recurrent adult brain tumor, glioblastoma multiforme (GBM), Imatinib, Imatinib mesylate, Hydroxyurea, Droxia, Hydrea, Hydroxycarbamide, Gleevec, Meningioma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed meningioma Recurrent or progressive disease after prior surgical resection Measurable disease by contrast-enhanced MRI Multifocal disease allowed No evidence of intratumor hemorrhage on pretreatment diagnostic imaging Stable postoperative grade 1 hemorrhage allowed No peripheral edema or central or systemic fluid collections ≥ grade 2 (e.g., pericardial effusion, pulmonary effusion, ascites) PATIENT CHARACTERISTICS: Karnofsky performance status 70-100% Absolute neutrophil count > 1,500/mm³ Hemoglobin > 9 g/dL Platelet count > 100,000/mm³ Potassium normal* Calcium normal* Magnesium normal* Phosphorus normal* alanine aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 times upper limit of normal (ULN) Bilirubin < 1.5 times ULN Creatinine < 1.5 times ULN OR creatinine clearance > 50 mL/min Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No excessive risk of bleeding, as defined by stroke within the past 6 months No active systemic bleeding (i.e., gastrointestinal bleeding or gross hematuria) No history of central nervous system (CNS) or intraocular bleeding or septic endocarditis No concurrent severe and/or uncontrolled medical disease, including any of the following: Uncontrolled diabetes Congestive cardiac failure Myocardial infarction within the past 6 months Poorly controlled hypertension History of labile hypertension History of poor compliance with antihypertensive regimen Chronic renal disease Active uncontrolled infection requiring intravenous antibiotics No acute or chronic liver disease (i.e., hepatitis, cirrhosis) No HIV positivity No impairment of gastrointestinal function or disease that may significantly alter the absorption of imatinib mesylate, including any of the following: Ulcerative disease Uncontrolled nausea Vomiting Diarrhea Malabsorption syndrome Bowel obstruction Inability to swallow tablets No other malignancy within the past 5 years except basal cell skin cancer or cervical carcinoma in situ NOTE: *Unless correctable with supplements PRIOR CONCURRENT THERAPY: See Disease Characteristics Recovered from prior therapy More than 1 week since prior tumor biopsy More than 2 weeks since prior surgical resection Prior hydroxyurea allowed provided patient has not had progressive disease or toxicity > grade 3 No prior imatinib mesylate or other platelet-derived growth factor-directed therapy At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)* Chemotherapeutic agents such as etoposide that are normally given at shorter intervals allowed even if < 4 weeks from last prior dose of chemotherapy At least 4 weeks since prior radiotherapy* At least 1 week since prior biological, immunotherapeutic, or cytostatic drugs At least 2 weeks since prior investigational drugs No concurrent warfarin NOTE: *Unless there is unequivocal evidence of tumor progression
Sites / Locations
- Duke Cancer Institute
Arms of the Study
Arm 1
Experimental
Imatinib mesylate+hydroxyurea
All patients receive imatinib mesylate and hydroxyurea orally on a daily, continuous basis. Dosing of imatinib mesylate is adjusted for patients who are also receiving p450-inducing anti-epileptic drugs.