NCT00995358

A Study With Peptide Vaccination in Treating Patients With Esophageal Cancer

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Yamanashi · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Esophageal Cancer

Interventions

Type	Name	Description
BIOLOGICAL	peptide	Each of three peptides (1mg) mixed with IFA (1ml) were injected every week at five round.

Timeline

• Start date: 2008-11-01
• Primary completion: 2010-10-01
• Completion: 2011-10-01
• First posted: 2009-10-15
• Last updated: 2009-10-15

Locations

1 site across 1 country: Japan