Histocompatibility Leukocyte Antigen (HLA)-A*0201 Restricted Peptide Vaccine Therapy in Patients With Gastric Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00681252
• Date of registration: 19/05/2008
• Primary sponsor: Tokyo University
• Public title: Histocompatibility Leukocyte Antigen (HLA)-A*0201 Restricted Peptide Vaccine Therapy in Patients With Gastric Cancer
• Scientific title: Phase I/II Study of Multiple-Vaccine Therapy Using Epitope Peptide Restricted to HLA-A*0201 in Treating Patients With Refractory Gastric Cancer
• Date of first enrolment: May 2008
• Target sample size: 14
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00681252
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Japan

Contacts

• Name: Naohide Yamashita, MD/PhD
• Affiliation: The Institute of Medical Science, The University of Tokyo

Key inclusion & exclusion 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*0201

- Laboratory values as follows 2000/mm3100000/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



Age minimum: 20 Years
Age maximum: 85 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Gastric Cancer

Intervention(s)

Biological: URLC10, VEGFR1 and VEGFR2

Primary Outcome(s)

safety (Phase I: toxicities as assessed by NCI CTCAE version 3) and efficacy (Phase II: Feasibility as evaluated by RECIST) [Time Frame: two months]

Secondary Outcome(s)

To evaluate immunological responses [Time Frame: two months]

Secondary ID(s)

IMS-MKA0201

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Human Genome Center, Institute of Medical Science, University of Tokyo