Phase I/II Study of Multiple-Vaccine Therapy Using Epitope Peptide Restricted to HLA-A*0201 in Treating Patients With Refractory Esophageal 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. In a
prior study, it has been shown that URLC10 is upregulated in human esophageal tumors. 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 vaccines. In the following
phase II study, we evaluate the immunological and clinical response of this vaccine therapy.
Interventional
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)
two months
Yes
Naohide Yamashita, MD/PhD
Study Chair
The Institute of Medical Science, The University of Tokyo
Japan: Institutional Review Board
IMS-OKA0201
NCT00681421
May 2008
April 2009
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