Clinical trial · Interventional
Histocompatibility Leukocyte Antigen (HLA)-A*0201 Restricted Peptide Vaccine Therapy in Patients With Gastric Cancer
Phase I/II Study of Multiple-Vaccine Therapy Using Epitope Peptide Restricted to HLA-A*0201 in Treating Patients With Refractory Gastric Cancer
NCT00681252CI-TRIAL-00002793completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the safety and time to progression of HLA-A\*0201 restricted epitope peptides URLC10, VEGFR1 and VEGFR2 emulsified with Montanide ISA 51.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| URLC10, VEGFR1 and VEGFR2 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- A
- interventionNames
- Biological: URLC10, VEGFR1 and VEGFR2
Primary outcomes (1)
- measure
- safety (Phase I: toxicities as assessed by NCI CTCAE version 3) and efficacy (Phase II: Feasibility as evaluated by RECIST)
- timeFrame
- two months
Secondary outcomes (1)
- measure
- To evaluate immunological responses
- timeFrame
- two months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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/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
References
Publications (5)
- BACKGROUNDOkabe H, Satoh S, Kato T, Kitahara O, Yanagawa R, Yamaoka Y, Tsunoda T, Furukawa Y, Nakamura Y. Genome-wide analysis of gene expression in human hepatocellular carcinomas using cDNA microarray: identification of genes involved in viral carcinogenesis and tumor progression. Cancer Res. 2001 Mar 1;61(5):2129-37. PMID 11280777
- BACKGROUNDHasegawa S, Furukawa Y, Li M, Satoh S, Kato T, Watanabe T, Katagiri T, Tsunoda T, Yamaoka Y, Nakamura Y. Genome-wide analysis of gene expression in intestinal-type gastric cancers using a complementary DNA microarray representing 23,040 genes. Cancer Res. 2002 Dec 1;62(23):7012-7. PMID 12460921
- BACKGROUNDTakahashi M, Tsunoda T, Seiki M, Nakamura Y, Furukawa Y. Identification of membrane-type matrix metalloproteinase-1 as a target of the beta-catenin/Tcf4 complex in human colorectal cancers. Oncogene. 2002 Aug 29;21(38):5861-7. doi: 10.1038/sj.onc.1205755. PMID 12185585
- BACKGROUNDIshizaki H, Tsunoda T, Wada S, Yamauchi M, Shibuya M, Tahara H. Inhibition of tumor growth with antiangiogenic cancer vaccine using epitope peptides derived from human vascular endothelial growth factor receptor 1. Clin Cancer Res. 2006 Oct 1;12(19):5841-9. doi: 10.1158/1078-0432.CCR-06-0750. PMID 17020992
- BACKGROUNDWada S, Tsunoda T, Baba T, Primus FJ, Kuwano H, Shibuya M, Tahara H. Rationale for antiangiogenic cancer therapy with vaccination using epitope peptides derived from human vascular endothelial growth factor receptor 2. Cancer Res. 2005 Jun 1;65(11):4939-46. doi: 10.1158/0008-5472.CAN-04-3759. PMID 15930316