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

History of Changes

Tracking Information

First Received Date ^ICMJE

October 8, 2009

Last Updated Date

October 14, 2009

Start Date ^ICMJE

November 2008

Estimated Primary Completion Date

October 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Overall survival after the 1st vaccination [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00995358 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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

Phase 2

Study Design ^ICMJE

Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Arm (s)

Experimental: vaccination

Intervention: Biological: peptide

Publications *

Not Provided

* 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

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

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

Gender

Both

Ages

20 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Koji Kono, MD,PhD

+81-55-273-1111 ext 4124

kojikono@yamanashi.ac.jp

Location Countries ^ICMJE

Japan

Administrative Information

NCT Number ^ICMJE

NCT00995358

Other Study ID Numbers ^ICMJE

YMU-02

Has Data Monitoring Committee

Yes

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

Information Provided By

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

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