PEG-Interferon Alfa-2b in Treating Patients With Metastatic Kidney Cancer
- Conditions
- Kidney Cancer
- Registration Number
- NCT00045279
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States