Esophageal Cancer
Conditions
Keywords
Epitope peptide, CTL, Esophageal cancer, Vaccination
Brief summary
The purpose of this study is to evaluate the safety and immunological monitoring for peptide vaccination therapy using novel cancer testis antigens for locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma
Detailed description
We recently identified three HLA-A2402-restricted epitope peptides (TTK protein kinase (TTK), lymphocyte antigen 6 complex locus K (LY6K), and insulin-like growth factor (IGF)-II mRNA binding protein 3 (IMP-3)) derived from novel Cancer-Testis antigens (CTA) for the development of immunotherapies against esophageal squamous cell carcinoma (ESCC), and reported that the pre-existence of specific T cell responses to these epitope peptides were frequently seen in ESCC patients. Then, we performed Phase I vaccination trial using multi-epitopes involving TTK, LY6K, and IMP-3 peptides for locally advanced, recurrent or metastatic esophageal squamous cell carcinoma who had failed for the standard therapy. Each of three HLA-A2402-restricted epitope peptides mixed with IFA were injected every week at five round. Primary endpoints were to evaluate the safety and feasibility of the therapy. Secondary endpoints were to investigate the immunological monitoring and clinical effect.
Interventions
BIOLOGICALTTK, LY6K, and IMP-3 peptides
Each of three peptides (1mg) mixed with IFA (1ml) were injected every week at five round.
Sponsors
Human Genome Center, Institute of Medical Science, University of Tokyo
University of Yamanashi
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* DISEASE CHARACTERISTICS 1. Locally advanced, recurrent or metastatic esophageal squamous cell carcinoma who had failed for the standard therapy PATIENTS CHARACTERISTICS 1. ECOG performance status 0-2 2. Age≧20 years, 80≦years 3. WBC≥ 2,000/mm³ Platelet count ≥ 75,000/mm³ Total bilirubin ≤ 2.0 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 4. Patients must be HLA-A2402 5. 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 bleeding disorder 4. Serious infections requiring antibiotics 5. Concomitant treatment with steroids or immunosuppressing agent 6. Decision of unsuitableness by principal investigator or physician-in-charge
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety (toxicities as assessed by NCI CTCAE version 3) | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Immunological and clinical response | 1 year |
Countries
Japan
Contacts
Primary ContactKoji Kono, M.D. & Ph.D.
Backup ContactHideki Fujii, MD, PhD
Outcome results
None listed