Phase I/II Study of Multiple-Vaccine Therapy Using Epitope Peptide Restricted to HLA-A*2402 in Treating Patients With Refractory Breast Cancer
TTK has 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 peptide derived from this molecule and identified that this
peptide significantly induces 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 that peptide. Patients will be vaccinated twice a week for 8 weeks. On
each vaccination day, TTK-A24-567 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 this 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)
2 months
Yes
Masaru Shinozaki, MD/PhD
Principal Investigator
Head, Department of Surgery
Japan: Institutional Review Board
Breast-A24-I, II
NCT00678509
May 2008
March 2009
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