Peptide Vaccination in Treating Patients With Esophageal Cancer

May 23, 2008 updated by: University of Yamanashi

Phase I Study of Peptide Vaccination Therapy Using Novel Cancer Testis Antigens for Locally Advanced, Recurrent, or Metastatic Esophageal Squamous Cell Carcinoma

The purpose of this study is to evaluate the safety and immunological monitoring for peptide vaccination therapy using novel cancer testis antigens for locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

We recently identified three HLA-A2402-restricted epitope peptides (TTK protein kinase (TTK), lymphocyte antigen 6 complex locus K (LY6K), and insulin-like growth factor (IGF)-II mRNA binding protein 3 (IMP-3)) derived from novel Cancer-Testis antigens (CTA) for the development of immunotherapies against esophageal squamous cell carcinoma (ESCC), and reported that the pre-existence of specific T cell responses to these epitope peptides were frequently seen in ESCC patients. Then, we performed Phase I vaccination trial using multi-epitopes involving TTK, LY6K, and IMP-3 peptides for locally advanced, recurrent or metastatic esophageal squamous cell carcinoma who had failed for the standard therapy. Each of three HLA-A2402-restricted epitope peptides mixed with IFA were injected every week at five round. Primary endpoints were to evaluate the safety and feasibility of the therapy. Secondary endpoints were to investigate the immunological monitoring and clinical effect.

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Yamanashi
      • 1110 Shimokato, Chuo-city, Yamanashi, Japan, 409-3898
        • Recruiting
        • University of Yamanashi, First Department of Surgery
        • Principal Investigator:
          • Koji Kono, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

PATIENTS CHARACTERISTICS

  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. Patients must be HLA-A2402
  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Biological: TTK, LY6K, and IMP-3 peptides
Each of three peptides (1mg) mixed with IFA (1ml) were injected every week at five round.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety (toxicities as assessed by NCI CTCAE version 3)
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Immunological and clinical response
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Yamanashi

Collaborators

Human Genome Center, Institute of Medical Science, University of Tokyo

Investigators

  • Principal Investigator: Koji Kono, MD.PhD, First Depatment of Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Anticipated)

December 1, 2008

Study Completion (Anticipated)

December 1, 2009

Study Registration Dates

First Submitted

May 20, 2008

First Submitted That Met QC Criteria

May 20, 2008

First Posted (Estimate)

May 22, 2008

Study Record Updates

Last Update Posted (Estimate)

May 29, 2008

Last Update Submitted That Met QC Criteria

May 23, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YMU-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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