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Tumor Vaccine Therapy Against Advanced Gastric Cancer Using HLA-A*2402 Restricted Epitope Peptides Drived From URLC10

Phase 1
20 Years
80 Years
Not Enrolling
Gastric Cancer

Thank you

Trial Information

Tumor Vaccine Therapy Against Advanced Gastric Cancer Using HLA-A*2402 Restricted Epitope Peptides Drived From URLC10

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 are upregulated in esophageal cancer and gastric
cancer and other cancer. The investigators identified that peptides derived from these
proteins significantly induce the effective tumor specific CTL response in vitro. According
to these findings, in this trial, the investigators evaluate the safety, immunological and
clinical response of URLC10 peptide vaccine in the patients with gastric cancer. Patients
will be vaccinated once in one week to the eighth vaccine and will be vaccinated once in two
weeks from the ninth vaccine. On each vaccination day, the URLC10 peptide (1mg) mixed with
Montanide ISA 51 will be administered by endodermic injection

Inclusion Criteria:

1. Patients must have Advanced or recurrent gastric cancer, and treatment has failed, or
in the situation where effective therapy is not available, or has been refused due to
severe adverse effects of chemotherapy

2. WHO performance status of 0 to 2

3. Age ≥ 20 years, ≤80 years

4. The patient does not need to have a measurable disease, but must have a disease that
an effect judgment is possible

5. Passing from previous treatment more than two weeks.

6. Expected survival of at least 3 months

7. WBC≥ 1,500/mm³ WBC≤ 15,000/mm³ Platelet count ≥ 50,000/mm³ Total bilirubin≤ 3 x the
institutional normal upper limits AST, ALT ≤ 3 x the institutional normal upper
limits Creatinine ≤ 3 x the institutional normal upper limits

8. Patients must be HLA-A2402

9. Able and willing to give valid written informed consent

Exclusion Criteria:

1. Pregnancy, Promise of the pregnancy, Hope of the pregnancy, Breastfeeding

2. Serious infections requiring antibiotics

3. Concurrent treatment with steroids or immunosuppressing agent

4. 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)

Outcome Time Frame:

28 days after beginning protocol

Safety Issue:


Principal Investigator

Hitoshi Shiozaki, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Department of Surgery


Japan: Institutional Review Board

Study ID:




Start Date:

September 2008

Completion Date:

September 2010

Related Keywords:

  • Gastric Cancer
  • peptide vaccine
  • URLC10
  • Stomach Neoplasms