Trial Information

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

RNF43 and TOMM34 have been identified as cancer specific molecules especially in colorectal
cancer using genome-wide expression profile analysis by cDNA microarray technique. VEGF
receptor 1 and 2 are essential targets to tumor angiogenesis, and we identified that
peptides derived from these receptors 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, RNF43 peptide (1mg), TOMM34 peptide
(1mg), VEGFR1 peptide (1mg) and VEGFR2 peptide (1mg) mixed with Montanide ISA 51 will be
administered by subcutaneous injection. The patients will also receive oral chemotherapy
(Tegafur/Uracil/Folinate) simultaneously. Repeated cycles of the vaccine and the
chemotherapy 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 vaccine. In the following phase II study, we evaluate the
immunological and clinical response of this vaccine therapy.