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Phase I/II Study of Multiple-Vaccine Therapy Using Epitope Peptide Restricted to HLA-A*2402 in Treating Patients With Refractory Esophageal Cancer

Phase 1/Phase 2
20 Years
85 Years
Not Enrolling
Esophageal Cancer

Thank you

Trial Information

Phase I/II Study of Multiple-Vaccine Therapy Using Epitope Peptide Restricted to HLA-A*2402 in Treating Patients With Refractory Esophageal Cancer

URLC10, KOC1 and TTK have 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, KOC1 and TTK are upregulated in
human esophageal tumors. We identified that peptides derived from these proteins
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 peptide (1mg), KOC1 peptide (1mg), and TTK 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.

Inclusion Criteria:

- Advanced or recurrent esophageal cancer

- Resistant against conventional chemotherapy or difficult to continue the chemotherapy
due to intolerable side effect(s)

- ECOG performance status 0-2

- Life expectancy > 3 months

- HLA-A*2402

- Laboratory values as follows 2000/mm3100000/mm3
Bilirubin < 3.0mg/dl Asparate transaminase < 150IU/L Alanine transaminase < 150IU/L
Creatinine < 3.0mg/dl

- Able and willing to give valid written informed consent

Exclusion Criteria:

- Pregnancy (woman of childbearing potential:Refusal or inability to use effective
means of contraception)

- Breastfeeding

- Active or uncontrolled infection

- Concurrent treatment with steroids or immunosuppressing agent

- Prior chemotherapy, radiation therapy, and/or immunotherapy within 4 weeks

- Uncontrolled brain and/or intraspinal metastasis

- Decision of unsuitableness by principal investigator or physician-in-charge

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety(Phase I:toxicities as assessed by NCI CTCAE version3) and efficacy(Phase II:Feasibility as evaluated by RECIST)

Outcome Time Frame:

Two months

Safety Issue:


Principal Investigator

Naohide Yamashita, MD/PhD

Investigator Role:

Study Chair

Investigator Affiliation:

The Institutute of Medical Science, University of Tokyo


Japan: Institutional Review Board

Study ID:




Start Date:

May 2008

Completion Date:

April 2009

Related Keywords:

  • Esophageal Cancer
  • Peptide Vaccine
  • URLC10
  • TTK
  • KOC1
  • Esophageal Diseases
  • Esophageal Neoplasms