Clinical trial NCT00003126: Interleukin-2 in Treating Patients With Stage III or Stage IV Kidney Cancer
Official title: A Randomized Controlled Phase III Adjuvant Trial of High-Dose Bolus IL-2 in Patients With High-Risk Renal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Kidney Cancer
Keywords: renal cell cancer
renal cell carcinoma
interleukin-2
Lead sponsor: Loyola University
Sponsor class: OTHER
Collaborators: name: Chiron Corporation
First posted: 2003-10-28
Enrollment: 69
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Disease free survival
timeFrame: 60 months
Secondary outcomes:
measure: Overall survival
timeFrame: 60 months
Other outcomes:
Locations:
city: Duarte
country: United States
facility: Cancer Center and Beckman Research Institute, City of Hope
state: California
city: Los Angeles
country: United States
facility: USC/Norris Comprehensive Cancer Center and Hospital
state: California
city: Los Angeles
country: United States
facility: Jonsson Comprehensive Cancer Center, UCLA
state: California
city: Oakland
country: United States
facility: Summit Medical Center
state: California
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Cancer Center
state: Indiana
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center
state: Michigan
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
city: Lebanon
country: United States
facility: Norris Cotton Cancer Center
state: New Hampshire
city: Bronx
country: United States
facility: Our Lady of Mercy Medical Center
state: New York
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Portland
country: United States
facility: Earle A. Chiles Research Institute at Providence Portland Medical Center
state: Oregon
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: Loyola University
name: Joseph I. Clark, MD
role: PRINCIPAL_INVESTIGATOR
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