PEG-Interferon Alfa-2b and Sorafenib in Treating Patients With Unresectable or Metastatic Kidney Cancer

Inclusion Criteria:

• Must have histologically or cytologically confirmed clear cell renal cell carcinoma (RCC)
• Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension and is ≥ 1.0 cm by spiral CT scan
• No prior treatment except

PATIENT CHARACTERISTICS:

• ECOG performance status 0-1
• Life expectancy > 6 months
• Good/intermediate Motzer prognostic status
• ANC ≥ 1,000/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 10.0 g/dL
• Total bilirubin ≤ 2.0 mg/dL
• AST and ALT < 2.5 times normal
• Creatinine ≤ 1.8 mg/dL OR creatinine clearance > 50 mL/min
• Calcium < 12 mg/dL (when corrected for serum albumin)
• INR < 1.5 times upper limit of normal
• Adequate cardiac function, defined as left ventricular ejection fraction ≥ 40% by 2D echo
• Pulse oximetry ≥ 90% at rest on room air
• Not pregnant
• Negative pregnancy test
• Fertile patients must use effective contraception
• No evidence of bleeding diathesis
• No uncontrolled coagulation disorders
• No active infections requiring IV antibiotics
• No known HIV, hepatitis C, or hepatitis B
• No autoimmune disease requiring ongoing therapy
• No requirement for adrenal replacement
• No angina (controlled or uncontrolled)
• No uncontrolled hypertension

• No history of other major medical illnesses including, but not limited to, any of the following:

  • Cardiac ischemia
  • Myocardial infarction
  • Major cardiac arrhythmias
  • Inflammatory bowel disorders
• No other prior malignancy except for previously treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for 3 years
• No significant psychiatric disease that, in the opinion of the principal investigator, would preclude giving adequate informed consent or render immunotherapy unsafe

PRIOR CONCURRENT THERAPY:

• No prior treatment for RCC except sunitinib malate

  • Patients may have progressed or have been intolerant to sunitinib malate
• No prior systemic treatment for metastatic disease (other than sunitinib malate)
• No prior organ allografts
• At least 2 weeks since prior laparoscopic/robotic surgery
• At least 4 weeks since prior open nephrectomy
• More than 4 weeks since prior and no concurrent radiotherapy or other surgery
• More than 4 weeks since prior systemic steroids
• More than 2 weeks since prior topical, injected, or inhaled steroids
• No concurrent steroid therapy
• No concurrent Hypericum perforatum (St. John's wort)