Sunitinib Malate in Treating Younger Patients With Recurrent, Refractory, or Progressive Malignant Glioma or Ependymoma

Inclusion Criteria

• Patients must be diagnosed with ependymoma or high-grade glioma (World Health Organization [WHO] grade III/IV):
• Stratum A: recurrent/progressive/refractory malignant glioma (i.e., anaplastic astrocytoma, glioblastoma multiforme [including giant cell and gliosarcoma types], anaplastic oligodendroglioma, anaplastic oligoastrocytoma, or anaplastic ganglioglioma) within the brain with or without spinal cord disease
• Stratum B: recurrent/progressive/refractory ependymoma (including ependymoma variants) within the brain with or without spinal cord disease
• Patients with diffuse intrinsic pontine glioma are not eligible
• A histological diagnosis from either the initial presentation or at the time of recurrence is required
• Patients must have radiographically documented measurable disease in the brain, defined as at least one lesion that can be accurately measured in at least 2 planes
• To document the degree of residual tumor, the following must be obtained:
• All patients must have a brain MRI with and without gadolinium and a spine magnetic resonance imaging (MRI), if clinically indicated,with and without gadolinium, performed within 2 weeks prior to study enrollment
• Patients with evidence of new central nervous system (CNS) hemorrhage of more than punctate size and/or more than 3 foci of punctate hemorrhage on baseline MRI obtained within 14 days prior to study enrollment are not eligible
• Eastern Cooperative Oncology Group (ECOG) performance score of 0, 1, or 2 (use Karnofsky for patients > 16 years of age and Lansky for patients ≤ 16 years of age)
• Neurological deficits in patients must have been relatively stable for a minimum of 1 week prior to study enrollment; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score
• Peripheral absolute neutrophil count (ANC) ≥ 1,000/μL
• Platelet count ≥ 75, 000/μL (transfusion independent, defined as not receiving platelet transfusions within the 7-day period prior to enrollment)
• Hemoglobin ≥ 8.0 g/dL (may receive red blood cell [RBC] transfusions)
• Creatinine clearance or radioisotope glomerular filtration rate (GFR) ≥ 70 mL/min OR serum creatinine based on age/gender as follows:
• 0.4 mg/dL (1 month to 17 years: systolic blood pressure ≥ 140 mm Hg and/or diastolic blood pressure ≥ 90 mm Hg which is not controlled by one anti-hypertensive medication
• Ongoing cardiac dysrhythmias ≥ grade 2 or atrial fibrillation of any grade
• Unstable angina, symptomatic congestive heart failure, or myocardial infarction
• Patients with a seizure disorder may be enrolled if on non-enzyme-inducing anticonvulsants and well controlled
• Commonly used non-enzyme-inducing anticonvulsants include: gabapentin, lamotrigine, levetiracetam, tiagabine, topiramate, valproic acid, and zonisamide
• Patients must not have had a cerebrovascular accident or transient is chemic attack within 12 months prior to enrollment
• Patients must not have had a pulmonary embolism or other significant thromboembolic event within 12 months prior to enrollment
• Patients must not have had grade ≥ 3 hemorrhage within 4 weeks prior to enrollment
• Patients must not have had any of the following diagnoses within 6 months prior to enrollment: peptic ulcer disease, inflammatory bowel disease, or diverticulitis
• Patients with a diagnosis of abdomen fistula, gastrointestinal (GI) perforation, or intra-abdominal abscess within 6 months prior to enrollment are not eligible
• Patients who have an uncontrolled infection are not eligible
• Patients with hypothyroidism that has not been well-controlled by medications for at least 2 weeks prior to study entry are not eligible
• Patients who have a personal history of genetic and/or congenital cardiac abnormalities are not eligible
• Patients who have a history of allergic reactions to compounds of similar chemical or biological composition to suniti