Presented October 25th - 28th, 2007 at the 2007 Urological Research Society (URS) Meeting - Napa, California

Introduction: We have reported a phase-I study with carbonic anhydrase 9 (CA9) peptide vaccines for cytokine refractory RCC patients. In 23 patients enrolled in this study, 3 showed partial responses and 6 showed stable disease more than 6 months with vaccination monotherapy. Based on these results, we conducted a combination therapy with CA9 peptide vaccines and interferon-alpha (IFN-alpha).

Methods: 16 patients positive for human leukocyte antigen (HLA)-A24 with histologically confirmed RCC were enrolled in this study. Patients were vaccinated subcutaneously (sq) with each CA9 peptide vaccine (CA9p219, p288, p323) at two weeks interval, and after the 6th vaccination, patients started to self-inject IFN-alpha 300-600 million IU sq 3 times a week. Pre- and post vaccination blood samples were obtained from the patients for toxicity assessment and immunological studies. Clinical responses were evaluated every three months

Results and Conclusion: Peptide vaccinations were well tolerated with no major adverse event, and most of the patients developed specific CTL responses. One patient with lung and LN metastases achieved complete response and maintained NED for 12 months and another patient with multiple lung metastases showed PR. 3 showed stable disease for more than 6 months. At the time of the analysis, 9 patients were dead and 7 were alive with median follow up of 12 months. These findings suggest that our peptide vaccination therapy is safe and applicable for cytokine-refractory RCC patients.

Authors: Uemura H, Uejima S, Shimizu N, Tanaka M, Fujimoto K, Hirao Y

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