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Completed

NCT Number: NCT00874588

Peptide Vaccine Targeting to Cancer Specific Antigen Combined With Anti-angiogenic Peptide Antigen in Treating Patients With Non-small Cell Lung Cancer

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, CDCA1, VEGFR1 and VEGFR2 emulsified with Montanide ISA 51.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Fukushima Medical University

Fukushima, 960-1295, Japan

About this study

URLC10 and CDCA1 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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
  • Able and willing to give valid written informed consent

Exclusion criteria

  • Active and uncontrolled cardiac disease (includes patients with myocardial infarction within 6 months before entry)
  • Pregnancy (woman of child bearing potential)
  • Active and uncontrolled infectious disease
  • Adrenal cortical steroid hormone dependent status
  • Decision of unsuitableness by principal investigator

Treatment and study plan

HLA-A*2402restricted URLC10, CDCA1, VEGFR1 and VEGFR2

Biological

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 1.0mg and 3.0mg.

Primary outcomes

  1. 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

Secondary outcomes

  1. Peptides specific CTL responses in vitro

    Time frame: 3 months

  2. Objective response rate as assessed using RECIST criteria

    Time frame: 6 months

  3. Changes in levels of regulatory T cells

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Fukushima Medical University

Other

Collaborators

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

Registry information

Official study title

Phase I Trial in Studying Peptide Vaccine Therapy Targeting to Cancer Specific Antigen Combined With Anti-angiogenic Peptide Antigen in Treating Patients With Advanced or Recurrent Non-small Cell Lung Cancer

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Apr 2, 2009
Registry last updated
Aug 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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