Clinical trial · Interventional
Safety Study of Multiple Peptide Vaccine to Esophageal Cancer
Phase 1 Study of Multiple Peptide Vaccine Therapy and GM-CSF in Treating Patients With Esophageal Cancer
NCT00561275CI-TRIAL-00001568completedPhase 1ClinicalTrials.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)
This is a phase 1 study of multiple peptide vaccine therapy and GM-CSF in treating patients with esophageal cancer.
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 |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LY6K, VEGFR1, VEGFR2 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Toxicity of multiple peptide vaccinations
- timeFrame
- one year
Secondary outcomes (1)
- measure
- Immune responses including LY6K, VEGFR1 and VEGFR2 specific T cells
- timeFrame
- one year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients must have metastatic disease of esophageal cancer, and treatment has failed, or in the situation where effective therapy is not available, or has been refused due to severe adverse effects of chemotherapy 2. WHO performance status of 0 to 2 3. Age ≥ 20 years, ≤75 years 4. Chemotherapy, any type of radiation therapy, or immunotherapy within 4 weeks before study entry 5. Expected survival of at least 3 months 6. WBC≥ 2,000/mm³ Platelet count ≥ 100,000/mm³ Total bilirubin ≤ 1.5 x the institutional normal upper limits AST, ALT, ALP ≤ 2.5 x the institutional normal upper limits Creatinine ≤ 1.5 x the institutional normal upper limits 7. Patients must be HLA-A2402 8. Primary lesion of esophageal cancer must express LY6K 9. Able and willing to give valid written informed consent Exclusion Criteria: 1. Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception) 2. Breastfeeding 3. Serious infections requiring antibiotics 4. Patient with peptic ulcer disease 5. Previous history of intestinal perforation 6. bleeding disorders (INR ≥ 1.5) 7. Necessity of drug-mediated inhibition with platelet function 8. Taking antithrombogenic agents within 10 days 9. Serious hypertension 10. Previous history of arterial thrombosis or venous thrombosis 11. Other malignancy within 5 years prior to entry into the study, except for treated non-melanoma skin cancer and cervical carcinoma in situ 12. Clinically significant heart disease or previous history of myocardial infarction within the past 12 months 13. Concomitant treatment with steroids or immunosuppressing agent 14. Disease to the central nervous system 15. Decision of unsuitableness by principal investigator or physician-in-charge
References
Publications (3)
- 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
- BACKGROUNDSuda T, Tsunoda T, Daigo Y, Nakamura Y, Tahara H. Identification of human leukocyte antigen-A24-restricted epitope peptides derived from gene products upregulated in lung and esophageal cancers as novel targets for immunotherapy. Cancer Sci. 2007 Nov;98(11):1803-8. doi: 10.1111/j.1349-7006.2007.00603.x. PMID 17784873