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A Study With Peptide Vaccination in Treating Patients With Esophageal Cancer

Sponsor
University of Yamanashi (Other)
Overall Status
Unknown status
CT.gov ID
NCT00995358
Collaborator
Human Genome Center, Institute of Medical Science, University of Tokyo (Other)
60
Enrollment
1
Location
1
Arm
35
Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Biological: peptide
 Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (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
Study Start Date :
Nov 1, 2008
Anticipated Primary Completion Date :
Oct 1, 2010
Anticipated Study Completion Date :
Oct 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: vaccination

Biological: peptide
Each of three peptides (1mg) mixed with IFA (1ml) were injected every week at five round.

Outcome Measures

Primary Outcome Measures

  1. Overall survival after the 1st vaccination [2 years]

Secondary Outcome Measures

  1. Antigen specific control response induced by vaccination [1 year]

  2. DTH response induced by vaccination [1 year]

  3. Time to progression after the 1st vaccination [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 First Department of Surgery, University of Yamanashi Chuo Yamanashi Japan 409-3898

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00995358
Other Study ID Numbers:
  • YMU-02
First Posted:
Oct 15, 2009
Last Update Posted:
Oct 15, 2009
Last Verified:
Oct 1, 2009
Keywords provided by , ,
Epitope peptide
CTL
Esophageal cancer
Vaccination
Additional relevant MeSH terms:
Esophageal Neoplasms

Study Results

No Results Posted as of Oct 15, 2009