Phase I/II Study of Multiple-Vaccine Therapy Using Epitope Peptide Restricted to HLA-A*0201 in Treating Patients With Refractory Non-Small Cell Lung Cancer
URLC10 has been identified as cancer specific molecules especially in non small cell lung
cancer using genome-wide expression profile analysis by cDNA microarray technique. We have
determined the HLA-A*0201 restricted epitope peptides derived from these molecules. We also
tend to use the peptides targeting to tumor angiogenesis. 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, the URLC10-117 peptide(1mg), VEGFR1 peptide(1mg) and VEGFR2
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 vaccine. In the following phase II study, we
evaluate the immunological and clinical response of this vaccine therapy.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
safety(Phase I:toxicities as assessed by NCI CTCAE version3) and efficacy(Phase II:Feasibility as evaluated by RECIST)
Naohida Yamashita, MD/PhD
The Institute of Medical Science, The University of Tokyo
Japan: Institutional Review Board