MRI in Predicting Response to Sunitinib Malate in Patients With Stage IV Kidney Cancer

DISEASE CHARACTERISTICS:

• Histologically confirmed renal cell carcinoma

  • Stage IV disease
• Has undergone nephrectomy
• Archival tumor tissue samples available
• No history or clinical evidence of brain metastasis

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2
• WBC ≥ 3,000/mm^3
• Absolute granulocyte count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3
• Serum creatinine ≤ 2.0 times upper limit of normal (ULN) OR creatinine clearance ≥ 40 mL/min
• Total bilirubin ≤ 1.5 times ULN (< 3.0 times ULN for patients with Gilbert's disease)
• AST and ALT ≤ 2.5 times ULN (≤ 5.0 times ULN for patients with liver metastases)
• INR ≤ 1.5
• PTT normal
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No pre-existing thyroid abnormality with thyroid-stimulating hormone that cannot be maintained in the normal range with medication
• No hypertension that cannot be controlled with medication (i.e., diastolic blood pressure ≥ 100 mm Hg despite optimal medical therapy)
• No cardiac dysrhythmias ≥ grade 2 by NCI CTCAE v3.0

• No concurrent serious illness including, but not limited to, the following:

  • Ongoing or active infection requiring parenteral antibiotics
  • Clinically significant cardiovascular disease (e.g., uncontrolled hypertension, myocardial infarction, or unstable angina)
  • NYHA class II-IV congestive heart failure
  • Serious cardiac arrhythmia requiring medication
  • Peripheral vascular disease ≥ grade 2 within the past year
  • Psychiatric illness and/or social situation that would limit compliance with study requirements

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• No prior antiangiogenesis therapy
• Prior radiotherapy to a symptomatic site of metastatic disease is allowed
• At least 2 weeks since prior radiotherapy and recovered
• No other concurrent investigational therapies
• No concurrent cytochrome P450 enzyme-inducing antiepileptic drugs (e.g., phenytoin, carbamazepine, or phenobarbital), rifampin, or St. John's wort