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A Study With Peptide Vaccination in Treating Patients With Esophageal Cancer

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ClinicalTrials.gov Identifier: NCT00995358
Recruitment Status : Unknown
Verified October 2009 by University of Yamanashi.
Recruitment status was:  Recruiting
First Posted : October 15, 2009
Last Update Posted : October 15, 2009
Sponsor:
Collaborator:
Human Genome Center, Institute of Medical Science, University of Tokyo
Information provided by:
University of Yamanashi

Tracking Information
First Submitted Date  ICMJE October 8, 2009
First Posted Date  ICMJE October 15, 2009
Last Update Posted Date October 15, 2009
Study Start Date  ICMJE November 2008
Estimated Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 14, 2009)
Overall survival after the 1st vaccination [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 14, 2009)
  • Antigen specific control response induced by vaccination [ Time Frame: 1 year ]
  • DTH response induced by vaccination [ Time Frame: 1 year ]
  • Time to progression after the 1st vaccination [ Time Frame: 1 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study With Peptide Vaccination in Treating Patients With Esophageal Cancer
Official Title  ICMJE Phase II Multicenter Trial of Peptide Vaccination Therapy Using Novel Cancer Testis Antigens for Locally Advanced, Recurrent, or Metastatic Esophageal Squamous Cell Carcinoma
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Esophageal Cancer
Intervention  ICMJE Biological: peptide
Each of three peptides (1mg) mixed with IFA (1ml) were injected every week at five round.
Study Arms  ICMJE Experimental: vaccination
Intervention: Biological: peptide
Publications *
  • 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.
  • Kono K, Iinuma H, Akutsu Y, Tanaka H, Hayashi N, Uchikado Y, Noguchi T, Fujii H, Okinaka K, Fukushima R, Matsubara H, Ohira M, Baba H, Natsugoe S, Kitano S, Takeda K, Yoshida K, Tsunoda T, Nakamura Y. Multicenter, phase II clinical trial of cancer vaccination for advanced esophageal cancer with three peptides derived from novel cancer-testis antigens. J Transl Med. 2012 Jul 9;10:141. doi: 10.1186/1479-5876-10-141.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 14, 2009)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2011
Estimated Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00995358
Other Study ID Numbers  ICMJE YMU-02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party First Department of Surgery, University of Yamanashi
Study Sponsor  ICMJE University of Yamanashi
Collaborators  ICMJE Human Genome Center, Institute of Medical Science, University of Tokyo
Investigators  ICMJE
Principal Investigator: Koji Kono, MD.PhD University of Yamanashi, First Deparment of Surgery
PRS Account University of Yamanashi
Verification Date October 2009

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