A Study With Peptide Vaccination in Treating Patients With Esophageal Cancer
Recruitment status was Recruiting
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).
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Multicenter Trial of Peptide Vaccination Therapy Using Novel Cancer Testis Antigens for Locally Advanced, Recurrent, or Metastatic Esophageal Squamous Cell Carcinoma|
- Overall survival after the 1st vaccination [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Antigen specific control response induced by vaccination [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- DTH response induced by vaccination [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Time to progression after the 1st vaccination [ Time Frame: 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||November 2008|
|Estimated Study Completion Date:||October 2011|
|Estimated Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
Each of three peptides (1mg) mixed with IFA (1ml) were injected every week at five round.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00995358
|Contact: Koji Kono, MD,PhD||+81-55-273-1111 ext firstname.lastname@example.org|
|First Department of Surgery, University of Yamanashi||Recruiting|
|Chuo, Yamanashi, Japan, 409-3898|
|Contact: Koji Kono, MD, PhD +81-552-73-1111 ext 4124 email@example.com|
|Principal Investigator: Koji Kono, MD, PhD|
|Principal Investigator:||Koji Kono, MD.PhD||University of Yamanashi, First Deparment of Surgery|