Status:
COMPLETED
Histocompatibility Leukocyte Antigen (HLA)-A*2402 Restricted Peptide Vaccine Therapy in Patients With Gastric Cancer
Lead Sponsor:
Tokyo University
Collaborating Sponsors:
Human Genome Center, Institute of Medical Science, University of Tokyo
Conditions:
Gastric Cancer
Eligibility:
All Genders
20-85 years
Phase:
PHASE1
PHASE2
Brief Summary
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.
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,...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2009
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00681577
Start Date
May 1 2008
End Date
October 1 2009
Last Update
November 19 2009
Active Locations (1)
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1
The Institutute of Medical Science, University of Tokyo
4-6-1, Shirokanedai, Minato-ku, Tokyo, Japan, 108-8639