TAILIEUCHUNG - Báo cáo hóa học: " Phase I clinical trial of the vaccination for the patients with metastatic melanoma using gp100derived epitope peptide "

Phase I clinical trial of the vaccination for the patients with metastatic melanoma using gp100derived epitope peptide | Baba et al. Journal of Translational Medicine 2010 8 84 http content 8 1 84 RESEARCH JOURNAL OF TRANSLATIONAL MEDICINE Open Access Phase I clinical trial of the vaccination for the patients with metastatic melanoma using gp100-derived epitope peptide restricted to HLA-A 2402 1t 1t 1 1 2 3 Toshiyuki Baba Marimo Sato-Matsushita Akira Kanamoto Akihiko Itoh Naoki Oyaizu Yusuke Inoue Yutaka Kawakami4 Hideaki Tahara1 Abstract Background The tumor associated antigen TAA gp100 was one of the first identified and has been used in clinical trials to treat melanoma patients. However the gp100 epitope peptide restricted to HLA-A 2402 has not been extensively examined clinically due to the ethnic variations. Since it is the most common HLA Class I allele in the Japanese population we performed a phase I clinical trial of cancer vaccination using the HLA-A 2402 gp100 peptide to treat patients with metastatic melanoma. Methods The phase I clinical protocol to test a HLA-A 2402 gp100 peptide-based cancer vaccine was designed to evaluate safety as the primary endpoint and was approved by The University of Tokyo Institutional Review Board. Information related to the immunologic and antitumor responses were also collected as secondary endpoints. Patients that were HLA-A 2402 positive with stage IV melanoma were enrolled according to the criteria set by the protocol and immunized with a vaccine consisting of epitope peptide VYFFLPDHL gp100-in4 emulsified with incomplete Freund s adjuvant IFA for the total of 4 times with two week intervals. Prior to each vaccination peripheral blood mononuclear cells PBMCs were separated from the blood and stored at -80 C. The stored PBMCs were thawed and examined for the frequency of the peptide specific T lymphocytes by IFN-g- ELISPOT and MHC-Dextramer assays. Results No related adverse events greater than grade I were observed in the six patients enrolled in this study. No clinical responses were observed in the .

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