77 PHASE I CLINICAL TRIAL OF NOVEL HIG2 DERIVED EPITOPE PEPTIDE VACCINE TREATMENT FOR KIDNEY CANCER (2010)

You have accessJournal of UrologyKidney Cancer: Basic Research I1 Apr 201077 PHASE I CLINICAL TRIAL OF NOVEL HIG2 DERIVED EPITOPE PEPTIDE VACCINE TREATMENT FOR KIDNEY CANCER Wataru Obara, Ryo Takata, Koji Yoshida, Takuya Tsunoda, Akira Togashi, Yusuke Nakamura, and Tomoaki Fujioka Wataru ObaraWataru Obara Morioka, Japan More articles by this author , Ryo TakataRyo Takata Morioka, Japan More articles by this author , Koji YoshidaKoji Yoshida Tokyo, Japan More articles by this author , Takuya TsunodaTakuya Tsunoda Tokyo, Japan More articles by this author , Akira TogashiAkira Togashi Tokyo, Japan More articles by this author , Yusuke NakamuraYusuke Nakamura Tokyo, Japan More articles by this author , and Tomoaki FujiokaTomoaki Fujioka Morioka, Japan More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2010.02.125AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES We had previously reported genome-wide expression profile analysis of kidney cancer by means of cDNA microarray and identified Hypoxia-inducible protein 2 (HIG2) as a specific onco-gene. We subsequently detected that stimulation using HLA-A02 restricted HIG2 derived peptide induce specific cytotoxicic T lymphocyte (CTL). We conducted Phase I clinical trial of a vaccine using this peptide and assessed both the safety and efficacy of vaccination for patients with advanced kidney cancer. METHODS The main eligibility criteria were metastatic kidney cancer patients who were already resistant to the standard immunotherapies or tyrosine kinase inhibitors, adequate organ function and having HLA-A*02 genotype. Patients were vaccinated on day 1, 8, 15 and 22 of each 28-day treatment cycles. On each vaccination day, 9 mer modified HIG2 (VLNLYLLGV) peptide emulsified with Montanaide ISA 51 adjuvant were injected by subcutaneously in a dose-escalation manner (doses of 0.5, 1.0, 3.0 mg/body, 3 patients/1 cohort). The primary end point was evaluation of safety and secondary end point was clinical response and immunological response. RESULTS Vaccinations were well tolerated without any serious adverse events. Of 9 patients who completed at least one course of the treatment, 6 (67%) developed immunological reactions at the injection sites. The disease control rate (SD > 4months) was 55.6% and the median overall survival time was more than 6.5 months. Specific CTLs reacting to HIG2 epitope peptide were induced 6 (67%) of the 9 patients. The clinical and immunological reaction was recognized for synchronization. CONCLUSIONS Our experience data suggest that novel HIG2 epitope peptide vaccine treatment is tolerable and may be an effective for patients with kidney cancer. Peptide specific CTLs could be induced by VEGFR2-169 peptide vaccine at a high rate. From an immunological point of view, the optimal dose for further clinical trial might therefore be 3.0 mg/body or higher. © 2010 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 183Issue 4SApril 2010Page: e32-e33 Advertisement Copyright & Permissions© 2010 by American Urological Association Education and Research, Inc.MetricsAuthor Information Wataru Obara Morioka, Japan More articles by this author Ryo Takata Morioka, Japan More articles by this author Koji Yoshida Tokyo, Japan More articles by this author Takuya Tsunoda Tokyo, Japan More articles by this author Akira Togashi Tokyo, Japan More articles by this author Yusuke Nakamura Tokyo, Japan More articles by this author Tomoaki Fujioka Morioka, Japan More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...