Esophageal Cancer
Conditions
Keywords
Epitope peptide, CTL, Esophageal cancer, Vaccination
Brief summary
The purpose of this study is to evaluate overall survival and immunological monitoring for peptide vaccination therapy using novel cancer testis antigens for locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC).
Detailed description
The phase I vaccination study using peptides derived from TTK, LY6K, and IMP-3 for locally advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) who had failed for the standard therapy indicated that the vaccine treatment were well tolerated and feasible, and that antigen-specific T cell responses were strongly induced by the vaccination with some objective clinical responses. Thus, we are currently initiating the randomized phase II clinical vaccination study for the same cohort with ESCC to evaluate the survival benefit of the cancer vaccination.
Interventions
BIOLOGICALpeptide
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 * Locally advanced, recurrent or metastatic esophageal squamous cell carcinoma who had failed for the standard therapy PATIENTS CHARACTERISTICS * ECOG performance status 0-2 * Age≧ 20≦ 80years * 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 * No therapy 4 weeks prior to the initiation of the trial * Able and willing to give valid written informed consent
Exclusion criteria
* Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception) * Breastfeeding * Serious bleeding disorder * Serious infections requiring antibiotics * Concomitant treatment with steroids or immunosuppressing agent * Decision of unsuitableness by principal investigator or physician-in-charge
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival after the 1st vaccination | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Antigen specific control response induced by vaccination | 1 year |
| DTH response induced by vaccination | 1 year |
| Time to progression after the 1st vaccination | 1 year |
Countries
Japan
Contacts
Primary ContactKoji Kono, MD,PhD
Outcome results
None listed