Interleukin-2 in Treating Patients With Stage III or Stage IV Kidney Cancer

• Status: Completed
• Trial end date: 2002-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Loyola University
• Collaborator: Chiron Corporation
• Treatments: Aldesleukin; Interleukin-2

Criteria

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