Interleukin-2 in Treating Patients With Stage III or Stage IV Kidney Cancer
Interleukin-2 in Treating Patients With Stage III or Stage IV Kidney Cancer
The purpose of this study is to assess the efficacy of post-operative high-dose bolus
 interleukin-2 (IL-2) in patients with high-risk renal cell carcinoma (RCC).
The primary objective of this prospective, randomized, controlled trial is to compare the
 disease-free and overall survival of patients with stage III or IV high-risk renal cell
 carcinoma (RCC) who were treated with adjuvant high-dose interleukin-2 vs observation alone.

 Patients are stratified according to their disease classification and randomized to one
 course of IL-2 [600,000 U/kg every 8 hours on days 1 to 5 and days 15 to 19 (maximum 28
 doses)] or observation.
Inclusion Criteria

 -  An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

 -  Adequate organ function as defined by a white blood cell (WBC) count of 4,000/L; a
 platelet count of 100,000/L; a Hemoglobin level of 10 g/dL; a serum creatinine of 1.5
 mg/dL or creatinine clearance of 60 mL/min; and a direct bilirubin level of 1.5 mg/dL.

 -  Forced expiratory volume at 1 second more than 2.0 L or 75% of predicted for height
 and age from pre-enrollment pulmonary function testing.

 -  No history or evidence of cardiac disease on ECG

 -  No prior systemic treatment for RCC, but patients may have received prior locoregional
 radiation therapy to solitary resectable metastases, which must have undergone
 surgical resection before enrollment.

 -  No prior history of invasive malignancy in the past 5 years

 -  Human immunodeficiency virus (HIV) negative

 -  Female patients must not be pregnant or planning to become pregnant

 Exclusion criteria

 • Age younger than 16