Kidney Cancer Clinical Trial
Sorafenib in Treating Patients With Kidney Cancer That Has Spread to the Brain
Summary
This phase II trial is studying how well sorafenib works in treating patients with kidney cancer that has spread to the brain. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
Full Description
PRIMARY OBJECTIVES:
I. Determine the partial and minor response rate in patients with renal cell carcinoma (RCC) metastatic to the brain treated with sorafenib.
SECONDARY OBJECTIVES:
I. Determine the toxicity of sorafenib in patients with RCC metastatic to the brain.
II. Determine whether the effect of sorafenib on RCC metastatic to the brain is similar to its effect on non-brain metastatic sites.
OUTLINE: This is a multicenter study.
Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
Eligibility 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
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There are 12 Locations for this study
Chicago Illinois, 60637, United States
Decatur Illinois, 62526, United States
Evanston Illinois, 60201, United States
Harvey Illinois, 60426, United States
Maywood Illinois, 60153, United States
Peoria Illinois, 61615, United States
Springfield Illinois, 62701, United States
Fort Wayne Indiana, 46885, United States
South Bend Indiana, 46601, United States
Saint Joseph Michigan, 49085, United States
Saint Louis Missouri, 63141, United States
Milwaukee Wisconsin, 53226, United States
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