Sorafenib in Treating Patients With Kidney Cancer That Has Spread to the Brain

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically or cytologically confirmed renal cell carcinoma metastatic to the brain
• •Measurable disease in the brain
• •Meets 1 of the following criteria:
• •* No prior brain-specific therapy AND no CNS symptoms referable to the brain lesion(s) (with or without concurrent steroid therapy)
• •* CNS symptoms referable to the brain lesion(s) AND received primary therapy for the brain lesion(s)
• •PATIENT CHARACTERISTICS:
• •Blood pressure \< 140/90 mm Hg on 2 separate occasions, taken at least 24 hours apart, within the past 6 weeks (patients on stable anti-hypertensive regimens allowed)
• •ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
• •Bilirubin \< 1.5 times upper limit of normal (ULN)
• •ALT/AST \< 2.5 times ULN
• •Estimated glomerular filtration rate \> 30 mL/min
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception
• •Able to swallow pills or comply with an oral treatment regimen
• •No history of a bleeding diathesis or requirement for full-dose anticoagulation
• •No history of allergic reactions attributed to compounds of similar chemical or biologic composition to sorafenib
• •No clinical or radiologic evidence of bowel obstruction or perforation
• •No other uncontrolled intercurrent illness including, but not limited to, any of the following:
• •* Ongoing or active infection
• •* Symptomatic congestive heart failure
• •* Unstable angina pectoris
• •* Cardiac arrhythmia
• •* Psychiatric illness or social situation that would limit compliance with study requirements
• •PRIOR CONCURRENT THERAPY:
• •More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) and recovered
• •More than 4 weeks since prior radiotherapy to sites outside of the brain and recovered
• •More than 8 weeks since prior standard external-beam radiotherapy to the brain unless there is evidence of in-brain progression
• •No prior complete surgical resection or radiosurgery of all known brain metastases unless there is evidence of in-brain progression
• •No prior sorafenib, sunitinib malate, bevacizumab, or any other agent targeting the platelet-derived growth factor receptor (PDGFR) or vascular endothelial growth factor receptor (VEGFR) kinase cascade
• •No other concurrent investigational agents
• •No concurrent enzyme-inducing anti-seizure medications, including phenytoin, phenobarbital, carbamazepine, or primidone
• •* Concurrent non-enzyme-inducing anti-seizure medications allowed
• •No concurrent combination antiretroviral therapy for HIV-positive patients
• •No concurrent hematopoietic growth factors except erythropoietin
• •No concurrent ketoconazole, itraconazole, or ritonavir
• •No concurrent grapefruit juice
• •No concurrent Hypericum perforatum (St. John's wort)
• •No concurrent chemotherapy
• •No concurrent hormonal therapy except steroids for adrenal failure and/or control of CNS edema or hormones for non-disease related conditions (e.g., insulin for diabetes)
• •No concurrent palliative radiotherapy
• •No other concurrent anticancer therapy
• •Concurrent bisphosphonates allowed