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Histocompatibility Leukocyte Antigen (HLA)-A*0201 Restricted Peptide Vaccine Therapy in Patients With Non-Small Cell Lung Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Tokyo University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Human Genome Center, Institute of Medical Science, University of Tokyo
Information provided by:
Tokyo University
ClinicalTrials.gov Identifier:
NCT00673777
First received: May 5, 2008
Last updated: May 12, 2008
Last verified: May 2008
History of Changes
  Purpose

The purpose of this study is to evaluate the safety and time to progression of HLA-A*0201 restricted epitope peptides URLC10, VEGFR1 and VEGFR2 emulsified with Montanide ISA 51.


Condition Intervention Phase
Non Small Cell Lung Cancer
 Biological: URLC10, VEGFR1 and VEGFR2
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by Tokyo University:

Primary Outcome Measures:
  • safety(Phase I:toxicities as assessed by NCI CTCAE version3) and efficacy(Phase II:Feasibility as evaluated by RECIST) [ Time Frame: two months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate immunological responses [ Time Frame: two months ] [ Designated as safety issue: No ]
  • Time to progression [ Time Frame: one years ] [ Designated as safety issue: No ]

Estimated Enrollment: 14
Study Start Date: May 2008
Estimated Study Completion Date: April 2009
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Biological: URLC10, VEGFR1 and VEGFR2
Patients will be vaccinated twice a week for 8 weeks. On each vaccination day, the URLC10-117 peptide(1mg), VEGFR1 peptide(1mg) and VEGFR2 peptide(1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection.

Detailed Description:

URLC10 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*0201 restricted epitope peptides derived from these molecules. We also tend to use the peptides targeting to tumor angiogenesis. VEGF receptor 1 and 2 are essential targets to tumor angiogenesis, and we identified that peptides derived from these receptors 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 URLC10-117 peptide(1mg), VEGFR1 peptide(1mg) and VEGFR2 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.

  Eligibility

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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*0201

  • 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
  • Unhealed external wound
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00673777

Contacts
Contact: Takeshi Fujii, MD/PhD 81-3-3443-8111 ext 75032 tmks@ims.u-tokyo.ac.jp

Locations
Japan
The Institute of Medical Science, The University of Tokyo Recruiting
Tokyo, Japan, 108-8639
Contact: Takeshi Fujii, MD/PhD     81-3-3443-8111 ext 75032     tmks@ims.u-tokyo.ac.jp    
Principal Investigator: Takeshi Fujii, MD/PhD            
Sponsors and Collaborators
Tokyo University
Human Genome Center, Institute of Medical Science, University of Tokyo
Investigators
Study Chair: Naohida Yamashita, MD/PhD The Institute of Medical Science, The University of Tokyo
  More Information

Publications:

Responsible Party: Department of Infectious Disease and Applied Immunology, The Institute of Medical Science, The University of Tokyo
ClinicalTrials.gov Identifier: NCT00673777     History of Changes
Other Study ID Numbers: IMS-NSCLC02
Study First Received: May 5, 2008
Last Updated: May 12, 2008
Health Authority: Japan: Institutional Review Board

Keywords provided by Tokyo University:
HLA-A*0201
Peptide Vaccine
URLC10
VEGFR1
VEGFR2

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
 Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 18, 2013