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Multiple-Vaccine Therapy in Treating Patients With Non-Small Cell Lung Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Fukushima Medical University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Human Genome Center, Institute of Medical Science, University of Tokyo
Information provided by:
Fukushima Medical University
ClinicalTrials.gov Identifier:
NCT00633724
First received: February 20, 2008
Last updated: March 30, 2009
Last verified: March 2009
History of Changes
  Purpose

The purpose of this study is to evaluate the safety, tolerability, immune response and clinical response of different doses of HLA-A*2402 restricted epitope peptides URLC10, TTK, VEGFR1 and VEGFR2 emulsified with Montanide ISA 51.


Condition Intervention Phase
Non Small Cell Lung Cancer
 Biological: HLA-A*2402restricted URLC10, TTK, VEGFR1 and VEGFR2
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Study of Multiple-Vaccine Therapy Including Antiangiogenic Vaccine Using Epitope Peptide Restricted to HLA-A*2402 in Treating Patients With Unresectable or Recurrent 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 Fukushima Medical University:

Primary Outcome Measures:
  • Adverse effects, dose limiting toxicity, and maximum tolerated dose as measured by CTCAE ver3.0 pre treatment, during study treatment, and 3 months after treatment [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Peptides specific CTL responses in vitro [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Objective response rate as assessed using RECIST criteria [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Changes in levels of regulatory T cells [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 9
Study Start Date: May 2007
Estimated Study Completion Date: May 2009
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Biological: HLA-A*2402restricted URLC10, TTK, VEGFR1 and VEGFR2
Escalating doses of every peptide will be administered by subcutaneous injection on days 1,8,15 and 22 of each 28-day treatment cycles. Planned doses of peptides are 0.5mg, 1.0mg and 3.0mg.

Detailed Description:

URLC10 and TTK have 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. 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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Disease characteristics

  1. Advanced or recurrent non small cell lung cancer
  2. Second line or later therapeutic status

Patient characteristics

  1. ECOG performance status 0-2
  2. Life expectancy > 3 months
  3. HLA-A*2402
  4. Laboratory values as follows 1500/mm3<WBC<15000/mm3 Platelet count>75000/mm3 Bilirubin < 3.0mg/dl Asparate transaminase < 99IU/L Alanine transaminase < 126IU/L Creatinine < 2.2mg/dl
  5. Able and willing to give valid written informed consent

Exclusion Criteria:

  1. Active and uncontrolled cardiac disease (includes patients with myocardial infarction within 6 months before entry)
  2. Pregnancy (woman of child bearing potential)
  3. Active and uncontrolled infectious disease
  4. Adrenal cortical steroid hormone dependent status
  5. Decision of unsuitableness by principal investigator
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00633724

Locations
Japan
Fukushima Medical University Hospital
Fukushima, Fuskushima, Japan, 960-1295
Sponsors and Collaborators
Fukushima Medical University
Human Genome Center, Institute of Medical Science, University of Tokyo
Investigators
Study Chair: Mitsukazu Gotoh, MD,PhD Fukushima Medical University, First department of Surgery
  More Information

Publications:

Responsible Party: First Department of Surgery, Fukushima Medical University
ClinicalTrials.gov Identifier: NCT00633724     History of Changes
Other Study ID Numbers: FVT-L0701
Study First Received: February 20, 2008
Last Updated: March 30, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare

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 May 19, 2013