Trial Information

Phase I/II Study of Multiple-Vaccine Therapy Using Epitope Peptide Restricted to HLA-A*2402 in Treating Patients With Refractory Esophageal Cancer

URLC10, KOC1 and TTK have been identified as cancer specific molecules especially in non
small cell lung cancer using genome-wide expression profile analysis by cDNA microarray
technique. In a prior study, it has been shown that URLC10, KOC1 and TTK are upregulated in
human esophageal tumors. We identified that peptides derived from these proteins
significantly induce the effective tumor specific CTL response in vitro and vivo. According
to these findings, in this trial, we evaluate the safety, immunological and clinical
response of those peptides. Patients will be vaccinated twice a week for 8 weeks. On each
vaccination day, the URLC10 peptide (1mg), KOC1 peptide (1mg), and TTK peptide (1mg) mixed
with Montanide ISA 51 will be administered by subcutaneous injection. Repeated cycles of
vaccine will be administered until patients develop progressive disease or unacceptable
toxicity, whichever occurs first. In the phase I study, we evaluate the safety and
tolerability of these peptide vaccines. In the following phase II study, we evaluate the
immunological and clinical response of this vaccine therapy.