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

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ClinicalTrials.gov Identifier: NCT00753844
Recruitment Status : Completed
First Posted : September 17, 2008
Last Update Posted : April 6, 2012
Sponsor:
Collaborator:
Human Genome Center, Institute of Medical Science, University of Tokyo
Information provided by (Responsible Party):
Hajime Ishikawa, Kinki University

Brief Summary:
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 or disease Intervention/treatment Phase
Esophageal Cancer Biological: URLC10 Phase 1

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tumor Vaccine Therapy Against Advanced Esophageal Cancer Using HLA-A*2402 Restricted Epitope Peptides Drived From URLC10
Study Start Date : November 2006
Actual Primary Completion Date : June 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources


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.


Primary Outcome Measures :
  1. Safety(Phase I:toxicities as assessed by NCI CTCAE version3) [ Time Frame: 28 days after beginning protocol ]

Secondary Outcome Measures :
  1. efficacy(Feasibility as evaluated by RECIST) [ Time Frame: 28 days after beginning protocol ]
  2. evaluate immunological responses [ Time Frame: 28 days after beginning protocol ]


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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Hajime Ishikawa, department of surgery, Kinki University
ClinicalTrials.gov Identifier: NCT00753844     History of Changes
Other Study ID Numbers: 18-29
First Posted: September 17, 2008    Key Record Dates
Last Update Posted: April 6, 2012
Last Verified: April 2012

Keywords provided by Hajime Ishikawa, Kinki University:
peptide vaccine
URLC10

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs