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

Completed · Phase 3

Conditions studied: Kidney Cancer

In brief

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).

Key facts

Study ID

NCT00003126

Run by

Loyola University

People needed

69

Starts

1997-06-01

Expected to finish

2002-08-01

Last updated by the study team

2017-01-04

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Age younger than 16

Where it is running

• Cancer Center and Beckman Research Institute, City of Hope — Duarte, California, United States
• USC/Norris Comprehensive Cancer Center and Hospital — Los Angeles, California, United States
• Jonsson Comprehensive Cancer Center, UCLA — Los Angeles, California, United States
• Summit Medical Center — Oakland, California, United States
• Loyola University Medical Center — Maywood, Illinois, United States
• Indiana University Cancer Center — Indianapolis, Indiana, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• University of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan, United States
• Barbara Ann Karmanos Cancer Institute — Detroit, Michigan, United States
• Norris Cotton Cancer Center — Lebanon, New Hampshire, United States
• Our Lady of Mercy Medical Center — The Bronx, New York, United States
• Carolinas Medical Center — Charlotte, North Carolina, United States
• Earle A. Chiles Research Institute at Providence Portland Medical Center — Portland, Oregon, United States
• Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States
• University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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