A Study With Peptide Vaccination in Treating Patients With Esophageal Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by University of Yamanashi.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Human Genome Center, Institute of Medical Science, University of Tokyo
Information provided by:
University of Yamanashi
ClinicalTrials.gov Identifier:
NCT00995358
First received: October 8, 2009
Last updated: October 14, 2009
Last verified: October 2009
  Purpose

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).


Condition Intervention Phase
Esophageal Cancer
Biological: peptide
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 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 after the 1st vaccination [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
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)
Arms Assigned Interventions
Experimental: vaccination Biological: peptide
Each of three peptides (1mg) mixed with IFA (1ml) were injected every week at five round.

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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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 ClinicalTrials.gov identifier: NCT00995358

Contacts
Contact: Koji Kono, MD,PhD +81-55-273-1111 ext 4124 kojikono@yamanashi.ac.jp

Locations
Japan
First Department of Surgery, University of Yamanashi Recruiting
Chuo, Yamanashi, Japan, 409-3898
Contact: Koji Kono, MD, PhD    +81-552-73-1111 ext 4124    kojikono@yamanashi.ac.jp   
Principal Investigator: Koji Kono, MD, PhD         
Sponsors and Collaborators
University of Yamanashi
Human Genome Center, Institute of Medical Science, University of Tokyo
Investigators
Principal Investigator: Koji Kono, MD.PhD University of Yamanashi, First Deparment of Surgery
  More Information

No publications provided by University of Yamanashi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: First Department of Surgery, University of Yamanashi
ClinicalTrials.gov Identifier: NCT00995358     History of Changes
Other Study ID Numbers: YMU-02
Study First Received: October 8, 2009
Last Updated: October 14, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Esophageal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on August 18, 2014