Interleukin-2 in Treating Patients With Metastatic Kidney Cancer
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.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Interleukin-2 In An Alternative Dose (The Iliad Trial): Treatment Of Patients With Metastatic Renal Cell Carcinoma With Low Dose Proleukin|
|Study Start Date:||July 2000|
|Study Completion Date:||July 2007|
|Primary Completion Date:||July 2007 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006864
|United States, Connecticut|
|Northwestern Connecticut Oncology-Hematology Associates|
|Torrington, Connecticut, United States, 06790|
|United States, Ohio|
|Ireland Cancer Center|
|Cleveland, Ohio, United States, 44106-5065|
|Study Chair:||Cindy Connell, MD, PhD||University Hospitals Seidman Cancer Center|