NCT00006864

Interleukin-2 in Treating Patients With Metastatic Kidney Cancer

Interleukin-2 In An Alternative Dose (The Iliad Trial): Treatment Of Patients With Metastatic Renal Cell Carcinoma With Low Dose Proleukin

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: —
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill kidney cancer cells. PURPOSE: Phase IV trial to study the effectiveness of interleukin-2 in treating patients who have metastatic kidney cancer.

Detailed description

OBJECTIVES: * Determine the overall response rate, complete and partial response rates, and duration of response in patients with metastatic renal cell carcinoma treated with low-dose interleukin-2. * Determine the overall survival, one-year progression-free survival, and two-year progression-free survival in patients treated with this regimen. * Determine the incidence of adverse events in these patients. OUTLINE: This is a multicenter study. Patients receive low-dose interleukin-2 subcutaneously 5 days a week for 6 weeks. Courses repeat every 9 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years. PROJECTED ACCRUAL: A total of 464 patients will be accrued for this study.

Conditions

• Kidney Cancer

Interventions

Type	Name	Description
BIOLOGICAL	aldesleukin

Timeline

• Start date: 2000-07-01
• Primary completion: 2007-07-01
• Completion: 2007-07-01
• First posted: 2003-06-02
• Last updated: 2014-01-09

Locations

2 sites across 1 country: United States