Interferon Alfa (IFN-Alpha-1b) in Renal Cancer With Metastatic Kidney Cancer
RATIONALE: Interferon alfa may interfere with the growth of tumor cells and slow the growth of kidney cancer.
PURPOSE: This phase II trial is studying how well interferon alfa works in treating patients with metastatic kidney cancer.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of Interferon Alpha-1b (IFN Alpha-1b) in Patients With Metastatic Clear Cell Renal Carcinoma|
- Safety [ Designated as safety issue: Yes ]
- Efficacy [ Designated as safety issue: No ]
|Study Start Date:||February 2005|
|Study Completion Date:||April 2007|
|Primary Completion Date:||April 2007 (Final data collection date for primary outcome measure)|
- Determine the objective response rate in patients with metastatic renal clear cell carcinoma treated with interferon alfa-1b.
- Determine the toxicity of this drug in these patients.
OUTLINE: This is an open-label study.
Patients receive interferon alfa-1b subcutaneously daily. Treatment continues in the absence of unacceptable toxicity or disease progression.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
|United States, Ohio|
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44195|
|Study Chair:||Ronald M. Bukowski, MD||The Cleveland Clinic|