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

May 19, 2008
November 18, 2009
May 2008
October 2009   (final data collection date for primary outcome measure)
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 ]
safety(Phase I:toxicities as assessed by NCI CTCAE version3) and efficacy(Phase II:Feasibility as evaluated by RECIST) [ Time Frame: two months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00681577 on ClinicalTrials.gov Archive Site
To evaluate immunological responses [ Time Frame: two months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Histocompatibility Leukocyte Antigen (HLA)-A*2402 Restricted Peptide Vaccine Therapy in Patients With Gastric Cancer
Phase I/II Study of Multiple-Vaccine Therapy Using Epitope Peptide Restricted to HLA-A*2402 in Treating Patients With Refractory Gastric Cancer

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.

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.

Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Gastric Cancer
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.
Experimental: A
Intervention: Biological: URLC10, KOC1, VEGFR1 and VEGFR2

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
October 2009
October 2009   (final data collection date for primary outcome measure)

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
Both
20 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00681577
IMS-MKA2402
Yes
Naohida Yamashita, MD/PhD, The Institute of Medical Science, The University of Tokyo
Tokyo University
Human Genome Center, Institute of Medical Science, University of Tokyo
Study Chair: Naohide Yamashita, MD/PhD The Institute of Medical Science, The University of Tokyo
Tokyo University
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP