Low Dose Decitabine + Interferon Alfa-2b in Advanced Renal Cell Carcinoma

Summary

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.

Timeline

Start

2007-10

Primary completion

2009-11

Completion

2009-11

Drugs

Indications