Histocompatibility Leukocyte Antigen (HLA)-A*2402 Restricted Peptide Vaccine Therapy in Patients With Non-Small Cell Lung Cancer

May 12, 2008 updated by: Tokyo University

Phase I/II Study of Multiple-Vaccine Therapy Using Epitope Peptide Restricted to HLA-A*0201 in Treating Patients With Refractory Non-Small Cell Lung Cancer

The purpose of this study is to evaluate the safety and time to progression of HLA-A*2402 restricted epitope peptides URLC10, TTK and KOC1 emulsified with Montanide ISA 51.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

URLC10,TTK and KOC1 has been identified as cancer specific molecules especially in non small cell lung cancer using genome-wide expression profile analysis by cDNA microarray technique. We have determined the HLA-A*2402 restricted epitope peptides derived from these molecules and identified that these peptides significantly induce the effective tumor specific CTL response in vitro and vivo. According to these findings, in this trial, we evaluate the safety, immunological and clinical response of those peptides. Patients will be vaccinated twice a week for 8 weeks. On each vaccination day, the URLC10-177 peptide(1mg), TTK-567 peptide(1mg) and KOC1-508 peptide(1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection. Repeated cycles of vaccine will be administered until patients develop progressive disease or unacceptable toxicity, whichever occurs first. In the phase I study, we evaluate the safety and tolerability of these peptide vaccine. In the following phase II study, we evaluate the immunological and clinical response of this vaccine therapy.

Study Type

Interventional

Enrollment (Anticipated)

14

Phase

  • Phase 2
  • 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
      • Tokyo, Japan, 108-8639
        • Recruiting
        • The Institute of Medical Science, The University of Tokyo
        • Contact:

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 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Disease characteristics

  • Advanced or recurrent non small cell lung cancer
  • Second line or later therapeutic status Patient characteristics
  • ECOG performance status 0-2
  • Life expectancy > 3 months
  • HLA-A*2402

  • Laboratory values as follows

    • 2000/mm3<WBC<15000/mm3
    • Platelet count>100000/mm3
    • Bilirubin < 3.0mg/dl
    • Asparate transaminase < 150IU/L
    • Alanine transaminase < 150IU/L
    • Creatinine < 3.0mg/dl
  • Able and willing to give valid written informed consent

Exclusion Criteria:

  • Pregnancy(woman of childbearing potential:Refusal or inability to use effective means of contraception)
  • Breastfeeding
  • Active or uncontrolled infection
  • Concurrent treatment with steroids or immunosuppressing agent
  • Prior chemotherapy,radiation therapy, or immunotherapy within 4 weeks
  • Uncontrolled brain and/or intraspinal metastasis
  • 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: B
Biological: URLC10, TTK and KOC1
Patients will be vaccinated twice a week for 8 weeks. On each vaccination day, the URLC10-117 peptide(1mg), TTK- peptide(1mg) and KOC1- peptide(1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
safety(Phase I:toxicities as assessed by NCI CTCAE version3) and efficacy(Phase II:Feasibility as evaluated by RECIST)
Time Frame: two months
two months

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate immunological responses
Time Frame: two months
two months

Collaborators and Investigators

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

Sponsor

Tokyo University

Collaborators

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

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

May 1, 2008

Primary Completion (Anticipated)

April 1, 2009

Study Completion (Anticipated)

April 1, 2009

Study Registration Dates

First Submitted

May 5, 2008

First Submitted That Met QC Criteria

May 5, 2008

First Posted (Estimate)

May 7, 2008

Study Record Updates

Last Update Posted (Estimate)

May 14, 2008

Last Update Submitted That Met QC Criteria

May 12, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMS-NSCLC24

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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