A Study With Peptide Vaccination in Treating Patients With Esophageal Cancer

Phase 2

• Conditions: Esophageal Cancer
• Interventions: Biological: peptide

• Registration Number: NCT00995358
• Lead Sponsor: University of Yamanashi

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.

Study Timeline

• Study Start: 2008-11
• Status Verified: 2009-10
• Study First Submitted: 2009-10-08
• Study First Submitted QC: 2009-10-14
• Last Update Submitted: 2009-10-14
• Study First Posted: 2009-10-15
• Last Update Posted: 2009-10-15
• Primary Completion: 2010-10
• Study Completion: 2011-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
vaccination	peptide	-

Primary Outcome Measures

Name	Time	Method
Overall survival after the 1st vaccination	2 years

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

First Department of Surgery, University of Yamanashi; 🇯🇵 Chuo, Yamanashi, Japan