Kidney Cancer
Conditions
Keywords
renal cell cancer, renal cell carcinoma, interleukin-2
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.
Interventions
DRUGInterleukin-2
High-dose bolus interleukin-2 is a systemic therapy used to treat metastatic RCC
Sponsors
Chiron Corporation
Loyola University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease free survival | 60 months | Disease free survival will be compared between the two cohorts (i.e., IL-2 versus Observation). Time will be calculated as the difference in months from date of treatment to date of death or recurrence (whichever occurs first). Patients remaining disease-free will be censored at the date of last follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 60 months | Overall survival will be compared between the two cohorts (i.e., IL-2 versus Observation). Time will be calculated as the difference in months from date of treatment to date of death. Living patients will be censored at the date of last follow-up. |
Countries
United States
Outcome results
None listed