A Phase II Study of Bevacizumab and Aldesleukin in Patients With Metastatic Renal Cell Carcinoma (RCC): A Cytokine Working Group (CWG) Study

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