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

Phase 1
20 Years
80 Years
Not Enrolling
Esophageal Cancer

Thank you

Trial Information

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

URLC10 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 are upregulated in human esophageal tumors. 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,
we evaluate the safety, immunological and clinical response of URLC10 peptide. 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 esophageal 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. Passing from radiation therapy
more than four 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. Disease to the central nervous system

5. 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:



Japan: Institutional Review Board

Study ID:




Start Date:

November 2006

Completion Date:

July 2009

Related Keywords:

  • Esophageal Cancer
  • peptide vaccine
  • URLC10
  • Esophageal Diseases
  • Esophageal Neoplasms