Phase I Study of Multiple-Vaccine Therapy Using Epitope Peptides Restricted to HLA-A*2402 in Treating Patients With Refractory Breast Cancer
CDCA1，URLC10，KIF20A，DEPDC1 and MPHOSPH1 have been identified as cancer specific molecules
especially in breast cancer using genome-wide expression profile analysis by cDNA microarray
technique. We have determined the HLA-A*2402 restricted epitope peptides derived from these
molecules and identified that these peptides 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 these peptides. Patients will be
vaccinated once a week until patients develop progressive disease or unacceptable toxicity.
On each vaccination day, CDCA1，URLC10，KIF20A，DEPDC1 and MPHOSPH1 peptides (0.5, 1 or 2mg of
each peptide) 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 peptides vaccine. Also we evaluate the immunological and
clinical response of this vaccine therapy.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
safety (Phase I: toxicities as assessed by NCI CTCAE version3)
Japan: Institutional Review Board