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Human Leukocyte Antigen (HLA) - A*2402 Restricted Peptide Vaccine Therapy in Patients With Advanced Esophageal Cancer

This study has been completed.
Sponsor:
Collaborator:
Human Genome Center, Institute of Medical Science, University of Tokyo
Information provided by (Responsible Party):
Hajime Ishikawa, Kinki University
ClinicalTrials.gov Identifier:
NCT00753844
First received: September 16, 2008
Last updated: April 4, 2012
Last verified: April 2012
History of Changes
  Purpose

The purpose of this study it to evaluate the safety and immune response of peptides (URLC10) emulsified with Montanide ISA51 in treating patients with unresectable, advanced or recurrent esophageal cancer.


Condition Intervention Phase
Esophageal Cancer
 Biological: URLC10
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Tumor Vaccine Therapy Against Advanced Esophageal Cancer Using HLA-A*2402 Restricted Epitope Peptides Drived From URLC10

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Kinki University:

Primary Outcome Measures:
  • Safety(Phase I:toxicities as assessed by NCI CTCAE version3) [ Time Frame: 28 days after beginning protocol ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • efficacy(Feasibility as evaluated by RECIST) [ Time Frame: 28 days after beginning protocol ] [ Designated as safety issue: No ]
  • evaluate immunological responses [ Time Frame: 28 days after beginning protocol ] [ Designated as safety issue: No ]

Enrollment: 7
Study Start Date: November 2006
Study Completion Date: July 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: URLC10
    Biological: URC10 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.
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00753844

Locations
Japan
department of surgery, Kinki University
Osakasayama, Osaka, Japan, 589-8511
Sponsors and Collaborators
Kinki University
Human Genome Center, Institute of Medical Science, University of Tokyo
  More Information

No publications provided

Responsible Party: Hajime Ishikawa, department of surgery, Kinki University
ClinicalTrials.gov Identifier: NCT00753844     History of Changes
Other Study ID Numbers: 18-29
Study First Received: September 16, 2008
Last Updated: April 4, 2012
Health Authority: Japan: Institutional Review Board

Keywords provided by Kinki University:
peptide vaccine
URLC10

Additional relevant MeSH terms:
Esophageal Diseases
Esophageal Neoplasms
Gastrointestinal Diseases
Digestive System Diseases
Gastrointestinal Neoplasms
 Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms

ClinicalTrials.gov processed this record on June 17, 2013