Imatinib Mesylate and Hydroxyurea in Treating Patients With Recurrent or Progressive Meningioma

Inclusion 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