A Study With Peptide Vaccination in Treating Patients With Esophageal Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase II Multicenter Trial of Peptide Vaccination Therapy Using Novel Cancer Testis Antigens for Locally Advanced, Recurrent, or Metastatic Esophageal Squamous Cell Carcinoma

Conditions
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Esophageal Cancer

Intervention / Treatment
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* Biological: peptide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vaccination<br> | Biological: peptide<br>* Each of three peptides (1mg) mixed with IFA (1ml) were injected every week at five round.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival after the 1st vaccination |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epitope peptide, CTL, Esophageal cancer, Vaccination