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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00845611
Recruitment Status : Completed
First Posted : February 18, 2009
Last Update Posted : April 6, 2012
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 gastric cancer.

Condition or disease Intervention/treatment Phase
Gastric Cancer Biological: peptide vaccine Phase 1

Detailed Description:
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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tumor Vaccine Therapy Against Advanced Gastric Cancer Using HLA-A*2402 Restricted Epitope Peptides Drived From URLC10
Study Start Date : September 2008
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
U.S. FDA Resources

Intervention Details:
    Biological: peptide vaccine
    peptides emulsified with Montanide ISA51
    Other Name: Peptides Drived From URLC10 emulsified with Montanide ISA51

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

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

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 identifier (NCT number): NCT00845611

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
Study Chair: Hitoshi Shiozaki, MD Department of Surgery

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Hajime Ishikawa, department of surgery, Kinki University Identifier: NCT00845611     History of Changes
Other Study ID Numbers: 20-27
First Posted: February 18, 2009    Key Record Dates
Last Update Posted: April 6, 2012
Last Verified: April 2012

Keywords provided by Hajime Ishikawa, Kinki University:
peptide vaccine

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Immunologic Factors
Physiological Effects of Drugs