Abstract
Survivin, an inhibitor of apoptosis protein (IAP), is abundantly expressed in most malignancies, but is hardly detectable in normal adult tissues. We previously reported that survivin was an ideal cancer antigen, and that the survivin-2B-derived peptide, survivin-2B80-88 (AYACNTSTL), could induce a cytotoxic T lymphocyte (CTL) response in the context of HLA-A24. Based on these findings, to assess its safety and efficacy, in September 2003 we performed a clinical trial using the peptide alone on patients with advanced or recurrent oral cancer. Vaccinations were administered six times at 14-day intervals. The results indicated that survivin-2B peptide vaccination was safe and had therapeutic potential for oral cancer patients. A subsequent clinical trial of the peptide in combination with incomplete Freund's adjuvant (IFA) and interferon (IFN)-α was commenced in September 2006. The survivin-2B peptide plus IFA vaccination was administered four times at 14-day intervals in combination with IFN-α, which was administered once or twice a week. To date, no severe adverse events have been observed. The results of this trial suggest that the survivin-2B peptide and IFA vaccination in combination with IFN-α induced the peptide specific CTL more effectively than the peptide alone, and that the vaccination was tolerated well by patients. This regimen may be useful as a new therapeutic modality for patients with oral cancer.