Kidney Cancer Clinical Trial
Official title:
Phase II Trial of PEG-Intron in Patients With Advanced Renal Cell Carcinoma
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.
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.
;
Masking: Open Label, Primary Purpose: Treatment
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