PEG-Interferon Alfa-2b in Treating Patients With Metastatic Kidney Cancer
RATIONALE: PEG-interferon alfa-2b may stop the growth of kidney cancer by stopping blood flow to the tumor.
PURPOSE: Phase II trial to study the effectiveness of PEG-interferon alfa-2b in treating patients who have metastatic kidney cancer.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of PEG-Intron in Patients With Advanced Renal Cell Carcinoma|
|Study Start Date:||April 2002|
|Study Completion Date:||September 2005|
|Primary Completion Date:||September 2005 (Final data collection date for primary outcome measure)|
- Determine the efficacy of PEG-interferon alfa-2b in patients with metastatic renal cell carcinoma.
- Determine the time to disease progression in patients treated with this drug.
- Determine the safety of this drug in these patients.
- Determine the quality of life of patients treated with this drug.
- Determine the effect of this drug on biological surrogates of antitumor activity (basic fibroblast growth factor, vascular endothelial growth factor, and interleukin-6 serum levels) in these patients.
OUTLINE: Patients receive PEG-interferon alfa-2b subcutaneously once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, at 2 weeks and at 2, 4, 8, and 12 months after initiation of study therapy, and then at completion of study therapy.
PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study within 15 months.
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Robert J. Motzer, MD||Memorial Sloan-Kettering Cancer Center|