Text Size

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

This study has been completed.
Sponsor:
Collaborator:
Human Genome Center, Institute of Medical Science, University of Tokyo
Information provided by:
Tokyo University
ClinicalTrials.gov Identifier:
NCT00681577
First received: May 19, 2008
Last updated: November 18, 2009
Last verified: November 2009
History of Changes
  Purpose

The purpose of this study is to evaluate the safety and time to progression of HLA-A*2402 restricted epitope peptides URLC10, KOC1, VEGFR1 and VEGFR2 emulsified with Montanide ISA 51.


Condition Intervention Phase
Gastric Cancer
 Biological: URLC10, KOC1, VEGFR1 and VEGFR2
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/II Study of Multiple-Vaccine Therapy Using Epitope Peptide Restricted to HLA-A*2402 in Treating Patients With Refractory Gastric Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Tokyo University:

Primary Outcome Measures:
  • safety (Phase I: toxicities as assessed by NCI CTCAE version 3) and efficacy (Phase II: Feasibility as evaluated by RECIST) [ Time Frame: two months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate immunological responses [ Time Frame: two months ] [ Designated as safety issue: No ]

Estimated Enrollment: 14
Study Start Date: May 2008
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Biological: URLC10, KOC1, VEGFR1 and VEGFR2
Patients will be vaccinated twice a week for 8 weeks. On each vaccination day, the URLC10 peptide (1mg), KOC1 peptide (1mg), VEGFR1 peptide (1mg) and VEGFR2 peptide (1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection in combination with S-1 chemotherapy.

Detailed Description:

URLC10 and KOC1 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 and KOC1 are upregulated in human gastric tumors. VEGF receptor 1 and 2 are essential targets to tumor angiogenesis, and we identified that peptides derived from these receptors significantly induce the effective tumor specific CTL response in vitro and vivo. According to these findings, in this trial, we evaluate the safety, immunological and clinical response of those peptides. Patients will be vaccinated twice a week for 8 weeks. On each vaccination day, the URLC10 peptide (1mg), KOC1 peptide (1mg), VEGFR1 peptide (1mg) and VEGFR2 peptide (1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection. The patients will also receive oral chemotherapy (S-1) simultaneously. Repeated cycles of vaccine will be administered until patients develop progressive disease or unacceptable toxicity, whichever occurs first. In the phase I study, we evaluate the safety and tolerability of these peptide vaccines. In the following phase II study, we evaluate the immunological and clinical response of this vaccine therapy.

  Eligibility

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Advanced or recurrent gastric cancer
  • Resistant against conventional chemotherapy or difficult to continue the chemotherapy due to intolerable side effect(s)
  • ECOG performance status 0-2
  • Life expectancy > 3 months
  • HLA-A*2402
  • Laboratory values as follows 2000/mm3<WBC<15000/mm3 Platelet count>100000/mm3 Bilirubin < 3.0mg/dl Asparate transaminase < 150IU/L Alanine transaminase < 150IU/L Creatinine < 3.0mg/dl
  • Able to receive oral TS-1 therapy
  • Able and willing to give valid written informed consent

Exclusion Criteria:

  • Pregnancy (woman of childbearing potential:Refusal or inability to use effective means of contraception)
  • Breastfeeding
  • Active or uncontrolled infection
  • Unhealed external wound
  • Concurrent treatment with steroids or immunosuppressing agent
  • Prior chemotherapy, radiation therapy, and/or immunotherapy within 4 weeks
  • Uncontrolled brain and/or intraspinal metastasis
  • History of allergy to Tegaful, Gimeracil and/or Oteracil
  • Decision of unsuitableness by principal investigator or physician-in-charge
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00681577

Locations
Japan
The Institutute of Medical Science, University of Tokyo
4-6-1, Shirokanedai, Minato-ku, Tokyo, Japan, 108-8639
Sponsors and Collaborators
Tokyo University
Human Genome Center, Institute of Medical Science, University of Tokyo
Investigators
Study Chair: Naohide Yamashita, MD/PhD The Institute of Medical Science, The University of Tokyo
  More Information

Publications:

Responsible Party: Naohida Yamashita, MD/PhD, The Institute of Medical Science, The University of Tokyo
ClinicalTrials.gov Identifier: NCT00681577     History of Changes
Other Study ID Numbers: IMS-MKA2402
Study First Received: May 19, 2008
Last Updated: November 18, 2009
Health Authority: Japan: Institutional Review Board

Keywords provided by Tokyo University:
Peptide Vaccine
URLC10
KOC1
VEGFR1
VEGFR2

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on May 21, 2013