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Phase I/II Study of Multiple-Vaccine Therapy Using Epitope Peptide Restricted to HLA-A*0201 in Treating Patients With Refractory Gastric Cancer

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

Thank you

Trial Information

Phase I/II Study of Multiple-Vaccine Therapy Using Epitope Peptide Restricted to HLA-A*0201 in Treating Patients With Refractory Gastric 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 gastric 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. The patients will also receive oral chemotherapy (S-1)
simultaneously. 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 gastric 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*0201

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

- Able to receive oral TS-1 therapy

- 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

- Unhealed external wound

- Concurrent treatment with steroids or immunosuppressing agent

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

- Uncontrolled brain and/or intraspinal metastasis

- History of allergy to Tegaful, Gimeracil and/or Oteracil

- 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 version 3) 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 Institute of Medical Science, The University of Tokyo


Japan: Institutional Review Board

Study ID:




Start Date:

May 2008

Completion Date:

April 2009

Related Keywords:

  • Gastric Cancer
  • Peptide Vaccine
  • URLC10
  • VEGFR1
  • VEGFR2
  • Stomach Neoplasms