Bevacizumab and Interleukin-2 in Treating Patients With Metastatic Kidney Cancer

DISEASE CHARACTERISTICS:

• Histologically confirmed metastatic renal cell carcinoma (RCC) with predominantly clear cell histology
• Measurable disease
• No history of tumor-related hemorrhage
• No history of CNS or brain metastases

PATIENT CHARACTERISTICS:

• Karnofsky performance status ≥ 80%
• Absolute neutrophil count ≥ 1,000/mm^3
• Platelet count ≥ 100,000/mm^3
• Hemoglobin ≥ 9 g/dL (transfusion or recombinant erythropoietin growth factors allowed)
• AST ≤ 2 times upper limit of normal (ULN) (5 times ULN if due to liver metastases)
• Serum total bilirubin ≤ 2 times ULN (except for patients with Gilbert's disease)
• Serum creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 60 mL/min

• FEV_1 ≥ 2.0 L or ≥ 75% of predicted

  • Pulmonary function testing required for patients over age 50 or with significant pulmonary or smoking history
• No history of cerebrovascular accident or transient ischemic attacks

• No evidence of any of the following cardiac conditions*:

  • Congestive heart failure
  • Symptoms of coronary artery disease
  • Myocardial infarction < 6 months prior to study entry
  • Serious cardiac arrhythmias
  • Unstable angina NOTE: *Patients > 40 years old or who have had a previous myocardial infarction > 6 months prior to study entry are required to have a negative or low probability cardiac stress test for cardiac ischemia
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

• No other malignancy within the past 5 years except nonmelanoma skin cancer or noninvasive cancer, such as cervical carcinoma in situ, superficial bladder cancer without local recurrence, or breast cancer in situ

  • Patients with a history of another invasive malignancy must be in complete remission for ≥ 5 years
• No positive serology for HIV, hepatitis B, or hepatitis C
• No significant co-morbid illness, such as uncontrolled diabetes or active infection, that would preclude study treatment

• No history of inflammatory bowel disease or other serious autoimmune disease

  • Thyroiditis or rheumatoid arthritis allowed
• No uncontrolled hypertension (i.e., blood pressure > 150/100 mm Hg)
• Proteinuria ≤ 3+ by dipstick OR proteinuria < 2 gm by 24-hour urine collection
• Urine protein:creatinine ration < 1.0
• No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study entry
• No significant traumatic injury within the past 28 days
• No serious, nonhealing wound, ulcer, or bone fracture
• No active bleeding
• No history of other serious hemorrhage, bleeding diathesis, or underlying coagulopathy
• No history of deep venous thrombosis, clinically significant peripheral vascular disease, or other thrombotic event

PRIOR CONCURRENT THERAPY:

• No organ allografts
• At least 4 weeks since prior radiotherapy or surgery and recovered
• No prior systemic therapy for metastatic RCC
• No prior bevacizumab or interleukin-2
• At least 2 weeks since prior steroids
• No major surgery or open biopsy within the past 28 days
• No minor surgical procedures, fine needle aspirations, or core biopsies within the past 7 days, except central venous catheter placement
• No concurrent major surgery
• No concurrent corticosteroids or other immunosuppressants