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Peptide Vaccination in Treating Patients With Esophageal Cancer
This study is currently recruiting participants.
Study NCT00682227   Information provided by University of Yamanashi
First Received: May 20, 2008   Last Updated: May 23, 2008   History of Changes

May 20, 2008
May 23, 2008
August 2006
December 2008   (final data collection date for primary outcome measure)
Safety (toxicities as assessed by NCI CTCAE version 3) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Safety [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00682227 on ClinicalTrials.gov Archive Site
Immunological and clinical response [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
 
Peptide Vaccination in Treating Patients With Esophageal Cancer
Phase I Study of Peptide Vaccination Therapy Using Novel Cancer Testis Antigens for Locally Advanced, Recurrent, or Metastatic Esophageal Squamous Cell Carcinoma

The purpose of this study is to evaluate the safety and immunological monitoring for peptide vaccination therapy using novel cancer testis antigens for locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma

We recently identified three HLA-A2402-restricted epitope peptides (TTK protein kinase (TTK), lymphocyte antigen 6 complex locus K (LY6K), and insulin-like growth factor (IGF)-II mRNA binding protein 3 (IMP-3)) derived from novel Cancer-Testis antigens (CTA) for the development of immunotherapies against esophageal squamous cell carcinoma (ESCC), and reported that the pre-existence of specific T cell responses to these epitope peptides were frequently seen in ESCC patients. Then, we performed Phase I vaccination trial using multi-epitopes involving TTK, LY6K, and IMP-3 peptides for locally advanced, recurrent or metastatic esophageal squamous cell carcinoma who had failed for the standard therapy. Each of three HLA-A2402-restricted epitope peptides mixed with IFA were injected every week at five round. Primary endpoints were to evaluate the safety and feasibility of the therapy. Secondary endpoints were to investigate the immunological monitoring and clinical effect.

Phase I
Interventional
Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Esophageal Cancer
Biological: TTK, LY6K, and IMP-3 peptides
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
10
December 2009
December 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • DISEASE CHARACTERISTICS 1. Locally advanced, recurrent or metastatic esophageal squamous cell carcinoma who had failed for the standard therapy

PATIENTS CHARACTERISTICS

  1. ECOG performance status 0-2
  2. Age≧20 years, 80≦years  
  3. 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
  4. Patients must be HLA-A2402
  5. Able and willing to give valid written informed consent

Exclusion Criteria:

  1. Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception)
  2. Breastfeeding
  3. Serious bleeding disorder
  4. Serious infections requiring antibiotics
  5. Concomitant treatment with steroids or immunosuppressing agent
  6. Decision of unsuitableness by principal investigator or physician-in-charge
Both
20 Years to 80 Years
No
Contact: Koji Kono, M.D. & Ph.D. +81-55-273-1111 ext 2337 kojikono@yamanashi.ac.jp
Contact: Hideki Fujii, MD, PhD +81-55-273-1111 ext 2337 hfujii@yamanashi.ac.jp
Japan
 
NCT00682227
Koji Kono, First Department of Surgery
YMU-01
University of Yamanashi
Human Genome Center, Institute of Medical Science, University of Tokyo
Principal Investigator: Koji Kono, MD.PhD First Depatment of Surgery
University of Yamanashi
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP