Vatalanib in Treating Patients With Recurrent or Progressive Meningioma
Brain and Central Nervous System Tumors, Sarcoma
About this trial
This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring adult grade I meningioma, adult grade II meningioma, adult grade III meningioma, adult malignant hemangiopericytoma, adult anaplastic meningioma, adult papillary meningioma, adult melanocytic lesion, recurrent adult brain tumor
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed meningioma, including the following subtypes: Benign meningioma Malignant meningioma Steroid dosage stable for ≥ 5 days Atypical meningiomas Hemangiopericytoma May or may not have neurofibromatosis (NF) type 1 or 2 disease Patients with a history of NF may have other stable CNS tumors, such as schwannoma, acoustic neuroma, or ependymoma only if those lesions have been stable for the past 6 months Progressive or recurrent disease by MRI or CT scan Prior radiotherapy allowed provided evidence of disease progression is documented by positron emission tomography, thallium scanning, magnetic resonance spectroscopy, or surgery to rule out radiation necrosis for patients treated with radiosurgery Recent resection of recurrent or progressive tumor allowed provided both of the following criteria are met: At least 4 weeks since prior surgery and recovered Evaluable residual disease PATIENT CHARACTERISTICS: Karnofsky performance status 60-100% Life expectancy > 12 weeks Absolute neutrophil count ≥ 2,000/mm³ Platelet count ≥ 100,000/mm³ Hemoglobin ≥ 10 g/dL (transfusion allowed) SGOT and SGPT < 2 times upper limit of normal (ULN) Bilirubin ≤ 1.5 times ULN Creatinine < 1.5 mg/dL Negative proteinuria dipstick OR total urinary protein ≤ 500 mg AND creatinine clearance ≥ 50 mL/min PT, INR, and PTT ≤ 1.5 times ULN Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for up to 6 months after completion of study treatment No history of any other cancer except nonmelanoma skin cancer or carcinoma in situ of the cervix, unless in complete remission and off all therapy for that disease for ≥ 3 years No disease that would obscure toxicity or dangerously alter drug metabolism No bleeding disorders No severe and/or uncontrolled medical conditions that would limit compliance with study requirements, including any of the following: Uncontrolled high blood pressure History of labile hypertension History of poor compliance with an antihypertensive regimen Unstable angina pectoris Symptomatic congestive heart failure Myocardial infarction within the past 6 months Serious uncontrolled cardiac arrhythmia Uncontrolled diabetes Active or uncontrolled infection Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of vatalanib (i.e., ulcerative disease, uncontrolled nausea, vomiting, or diarrhea, malabsorption syndrome, bowel obstruction, or inability to swallow tablets) QTc > 450 (male) or > 470 (female) Congenital or acquired long QTc syndrome PRIOR CONCURRENT THERAPY: See Disease Characteristics Recovered from prior therapy At least 4 weeks since prior radiotherapy, including external-beam radiotherapy, interstitial brachytherapy, or gamma-knife radiosurgery At least 4 weeks since prior investigational agents More than 4 weeks since prior cytotoxic therapy (6 weeks for nitrosoureas) More than 4 weeks since prior immunotherapy More than 2 weeks since prior noncytotoxic or biologic therapies At least 2 weeks since prior drugs that affect hepatic metabolism (steroids should be tapered off if not clinically indicated) At least 2 weeks since prior and no concurrent enzyme-inducing anticonvulsant drugs No prior antivascular endothelial growth factor therapy No other concurrent investigational agents or anticancer therapy (including chemotherapy, radiotherapy, hormonal therapy, or immunotherapy) No concurrent warfarin No concurrent grapefruit or grapefruit juice
Sites / Locations
- Hematology-Oncology Associates of Illinois
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University
- University Cancer Center at University of Washington Medical Center
Arms of the Study
Arm 1
Experimental
Vatalanib
Patients will be treated with 500 mg of vatalanib, administered orally, twice a day for 28 days (1 cycle). Patients will start at a dose of 250 mg twice a day and increase by 250 mg per day every 7 days until 500 mg twice a day is reached. Patients who are responding may remain on study treatment for 12 months.