PMID- 21143701 OWN - NLM STAT- MEDLINE DCOM- 20110311 LR - 20201215 IS - 1349-7006 (Electronic) IS - 1347-9032 (Linking) VI - 102 IP - 2 DP - 2011 Feb TI - Phase I clinical trial of survivin-derived peptide vaccine therapy for patients with advanced or recurrent oral cancer. PG - 324-9 LID - 10.1111/j.1349-7006.2010.01789.x [doi] AB - Survivin, a member of the inhibitor of apoptosis protein (IAP) family, is abundantly expressed in most malignancies, but is hardly detectable in normal adult tissues. Previously we have identified a human leukocyte antigen (HLA)-A24-restricted antigenic peptide, survivin-2B80-88 (AYACNTSTL), recognized by CD8(+) cytotoxic T lymphocytes (CTL). Survivin-2B80-88-specific CTL were induced efficiently from peripheral blood mononuclear cells (PBMC) of oral cancer patients after stimulation with the peptide in vitro. We conducted a phase I clinical study to evaluate the safety and the efficacy of survivin-2B80-88 peptide vaccination in HLA-A24-positive patients with advanced or recurrent oral cancer. The vaccines were given subcutaneously or intratumorally six times at 14-day intervals. Eleven patients were enrolled and 10 patients completed the vaccination protocol. No adverse events were observed in any patients. In two patients, the levels of serum squamous cell carcinoma (SCC) antigen decreased transiently during the period of vaccination. Tumor regression that was compatible with a partial response (PR) was noted in one patient. The remaining nine patients experienced progressive disease (PD). Immunologically, an increase of the peptide-specific CTL frequency was detected in six of the eight patients evaluated by HLA-A24/peptide tetramer analysis. The present clinical trial revealed that survivin-2B peptide vaccination was safe and had therapeutic potential for oral cancer patients. However, subsequent clinical trials in combination with various adjuvant drugs will be required to improve the immunological and therapeutic efficacy. This trial was registered with University Hospital Medical Information Network (UMIN) number UMIN000000976. CI - (c) 2010 Japanese Cancer Association. FAU - Miyazaki, Akihiro AU - Miyazaki A AD - Department of Oral Surgery Pathology, Sapporo Medical University School of Medicine, Sapporo, Japan. amiyazak@sapmed.ac.jp FAU - Kobayashi, Junichi AU - Kobayashi J FAU - Torigoe, Toshihiko AU - Torigoe T FAU - Hirohashi, Yoshihiko AU - Hirohashi Y FAU - Yamamoto, Takashi AU - Yamamoto T FAU - Yamaguchi, Akira AU - Yamaguchi A FAU - Asanuma, Hiroko AU - Asanuma H FAU - Takahashi, Akari AU - Takahashi A FAU - Michifuri, Yoshitaka AU - Michifuri Y FAU - Nakamori, Kenji AU - Nakamori K FAU - Nagai, Itaru AU - Nagai I FAU - Sato, Noriyuki AU - Sato N FAU - Hiratsuka, Hiroyoshi AU - Hiratsuka H LA - eng PT - Clinical Trial, Phase I PT - Journal Article DEP - 20101210 PL - England TA - Cancer Sci JT - Cancer science JID - 101168776 RN - 0 (Antigens, Neoplasm) RN - 0 (BIRC5 protein, human) RN - 0 (Cancer Vaccines) RN - 0 (Epitopes, T-Lymphocyte) RN - 0 (Inhibitor of Apoptosis Proteins) RN - 0 (Microtubule-Associated Proteins) RN - 0 (Survivin) RN - 0 (Vaccines, Subunit) SB - IM MH - Adult MH - Aged MH - Aged, 80 and over MH - Antigens, Neoplasm/immunology/*therapeutic use MH - Cancer Vaccines/*therapeutic use MH - Epitopes, T-Lymphocyte/immunology MH - Female MH - Humans MH - Immunotherapy, Active/*methods MH - Inhibitor of Apoptosis Proteins MH - Male MH - Microtubule-Associated Proteins/immunology/*therapeutic use MH - Middle Aged MH - Mouth Neoplasms/immunology/*therapy MH - Survivin MH - Vaccines, Subunit/therapeutic use EDAT- 2010/12/15 06:00 MHDA- 2011/03/12 06:00 CRDT- 2010/12/15 06:00 PHST- 2010/12/15 06:00 [entrez] PHST- 2010/12/15 06:00 [pubmed] PHST- 2011/03/12 06:00 [medline] AID - 10.1111/j.1349-7006.2010.01789.x [doi] PST - ppublish SO - Cancer Sci. 2011 Feb;102(2):324-9. doi: 10.1111/j.1349-7006.2010.01789.x. Epub 2010 Dec 10.