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

Inclusion Criteria

• •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