Phase II Clinical Trial With IFNαR in combination with the vaccine preparation NAcGM3/VSSP/montanide ISA 51 in the treatment of renal cell carcinoma, stage III or IV

Abstract

The phase II clinical trial with IFNαR, combined with the vaccine project NAcGM3/VSSP/Montanide ISA 51, in the treatment of renal cell carcinoma, stage III or IV, will aim to estimate the progression-free survival and assess the overall survival, the clinical antitumor response and the safety of both treatment regimens. This will involve a multi-center Phase II clinical trial, controlled, randomized, open, with two treatment groups in each of which 20 patients diagnosed with renal cell carcinoma stage III or IV will be included. Until the study section, there is no progression of the disease in any of the patients, so the progression-free survival is estimated at 100% for both study groups; overall survival is 100%, no death registered and with 22 months for the first one included. The clinical response obtained under the anti-tumor therapeutic regimens under study is considered ideal, as no case of disease progression has appeared in the patients enrolled in the research. All of them remain in stable disease, partial response or complete response to disease. It is concluded that the NAcGM3/VSSP/Montanide ISA 51 VG vaccine preparation combined with IFNα2bR is safe, with no clinically significant alterations of the biochemical parameters and mild to moderate adverse events that are recovered in a short time, with no sequelae for patients and that, most of the times, are due to interferon treatment.