Primary Objective:
- To determine the progression-free survival (PFS) times for patients with advanced renal
cell carcinoma (RCC) treated with decitabine and interferon alfa-2b.
Secondary Objectives:
- To determine the toxicity of the combination of decitabine and interferon alfa-2b at the
proposed dose and schedule in patients with advanced RCC
- To determine overall response by Response Evaluation Criteria in Solid Tumors (RECIST)
criteria for patients with advanced RCC treated with decitabine and interferon alfa-2b.
- To determine the overall survival times for patients with advanced RCC treated with
decitabine and interferon.
- To study the effects of decitabine and interferon alfa-2b on DNA methylation and gene
expression in patients' tumor and non-tumor tissues and their correlation with clinical
outcomes.
- To characterize the modulation of cellular immunity induced by the combination of
decitabine and interferon alfa-2b in patients with advanced RCC and to correlate these
results with clinical outcomes.