A Study With 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 2
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: peptide
Type: Biological
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 80 Years
Minimum Age: 20 Years
Gender: Both
Criteria: 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
Location
First Department of Surgery, University of Yamanashi
Chuo, Yamanashi, Japan
Status: Recruiting
Contact: Koji Kono, MD, PhD - +81-552-73-1111 - kojikono@yamanashi.ac.jp
Start Date
November 2008
Completion Date
October 2011
Sponsors
University of Yamanashi
Source
University of Yamanashi
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page