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Peptide Vaccination in Treating Patients With Esophageal Cancer (STF-II)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by University of Yamanashi.
Recruitment status was  Recruiting
Human Genome Center, Institute of Medical Science, University of Tokyo
Information provided by:
University of Yamanashi Identifier:
First received: December 27, 2010
Last updated: NA
Last verified: December 2010
History: No changes posted
The purpose of this study is to evaluate overall survival and immunological monitoring for peptide vaccination therapy using novel cancer testis antigens (STF-II) for locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma

Condition Intervention Phase
Esophageal Cancer
Biological: vaccination
Phase 2

Study Type: Interventional
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 (STF-II) for Locally Advanced, Recurrent, or Metastatic Esophageal Squamous Cell Carcinoma

Resource links provided by NLM:

Further study details as provided by University of Yamanashi:

Primary Outcome Measures:
  • overall survival [ Time Frame: death from start of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • CTL response [ Time Frame: CTL response after 5 round vaccination ] [ Designated as safety issue: No ]
  • DTH response [ Time Frame: Skin reaction after 5 round vaccination ] [ Designated as safety issue: No ]
  • Progression free survival [ Time Frame: time from start of vaccination until disease progreesion ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: April 2010
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: peptide vaccination Biological: vaccination
Biological/Vaccine: URLC10, CDCA1, and KOC1 peptides

Detailed Description:
The phase II multicenter trial of vaccination study using peptides derived from URLC10, CDCA1, and KOC1 for locally advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) who had failed for the standard therapy are performed to evaluate the survival benefit of the cancer vaccination.

Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:


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


  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. No therapy 4 weeks prior to the initiation of the trial
  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 -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01267578

Contact: Koji Kono, PhD, MD +81552737390

University of Yamanashi, First Department of Surgery Recruiting
Chuo, Yamanashi, Japan, 4093898
Contact: Koji Kono, PhD, MD    +81552737390   
Sub-Investigator: Kousaku Mimura, PhD. MD         
Sponsors and Collaborators
University of Yamanashi
Human Genome Center, Institute of Medical Science, University of Tokyo
Principal Investigator: Koji Kono, PhD, MD University of Yamanashi, First Department of Surgery
  More Information

1. Okabe H, Satoh S, Kato T, et al. Genome-wide analysis of gene expression in human hepatocellular carcinomas using cDNA microarray: identification of genes involved in viral carcinogenesis and tumor progression. Cancer Res 2001; 61: 2129-37. 2 Lin YM, Furukawa Y, Tsunoda T, Yue CT, Yang KC, Nakamura Y. Molecular diagnosis of colorectal tumors by expression profiles of 50 genes expressed differentially in adenomas and carcinomas. Oncogene 2002; 21: 4120-28. 3. Hasegawa S, Furukawa Y, Li M, et al. Genome-wide analysis of gene expression in intestinal-type gastric cancers using a complementary DNA microarray representing 23,040 genes. Cancer Res 2002; 62: 7012-17. 4. Suda T, Tsunoda T, Daigo Y, Nakamura Y, Tahara H. Identification of human leukocyte antigen-A24-restricted epitope peptides derived from gene products upregulated in lung and esophageal cancers as novel targets for immunotherapy. Cancer Sci 2007; 98: 1803-8. 5. Ishikawa N, Takano A, Yasui W, et al. Cancer-testis antigen lymphocyte antigen 6 complex locus K is a serologic biomarker and a therapeutic target for lung and esophageal carcinomas. Cancer Res 2007; 67: 11601-11. 6. Yoshiki Mizukami, Koji Kono, Yataro Daigo, et al. Detection of novel Cancer-Testis antigen-specific T-cell responses in TIL, regional lymph nodes and PBL in patients with esophageal squamous cell carcinoma. Cancer Science 2008 ;99:1448-54 6. Koji Kono, Yoshiki Mizukami, Yataro Daigo, Atsushi Takano, Ken Masuda, Koji Yoshida, Takuya Tsunoda, Yoshihiko Kawaguchi, Yusuke Nakamura, and Hideki Fujii. Vaccination with Multiple Peptides derived from Novel Cancer-Testis Antigens Can Induce Specific T-Cell Responses and Clinical Responses in Advanced Esophageal cancer. Cancer Sci. 2009;100:1502-9.

Responsible Party: First Department of Surgery, University of Yamanashi Identifier: NCT01267578     History of Changes
Other Study ID Numbers: YMU-03 
Study First Received: December 27, 2010
Last Updated: December 27, 2010
Health Authority: Safety and evaluation commitee, Captivation-network : JAPAN

Keywords provided by University of Yamanashi:
Epitope peptide, CTL, Esophageal cancer, Vaccination

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Immunologic Factors
Physiological Effects of Drugs processed this record on October 25, 2016