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,TTK and KOC1 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*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 those peptides. Patients will be vaccinated
twice a week for 8 weeks. On each vaccination day, the URLC10-177 peptide(1mg), TTK-567
peptide(1mg) and KOC1-508 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.
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-NSCLC24
NCT00674258
May 2008
April 2009
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