Peptide Vaccination in Treating Patients With Esophageal Cancer
Conditions
Esophageal Cancer
Conditions: official terms
Esophageal Neoplasms
Conditions: Keywords
Epitope peptide, CTL, Esophageal cancer, Vaccination
Study Type
Interventional
Study Phase
Phase 1
Study Design
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: TTK, LY6K, and IMP-3 peptides
Type: Biological
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 80 Years
Minimum Age: 20 Years
Gender: Both
Criteria: 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
Location
University of Yamanashi, First Department of Surgery
1110 Shimokato, Chuo-city, Yamanashi, Japan
Status: Recruiting
Start Date
August 2006
Completion Date
December 2009
Sponsors
University of Yamanashi
Source
University of Yamanashi
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page