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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Non Small Cell Lung Cancer

Intervention / Treatment
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* Biological: HLA-A*2402restricted URLC10, TTK, VEGFR1 and VEGFR2


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Biological: HLA-A*2402restricted URLC10, TTK, VEGFR1 and VEGFR2<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peptides specific CTL responses in vitro |  | 3 months | 
| Objective response rate as assessed using RECIST criteria |  | 6 months | 
| Changes in levels of regulatory T cells |  | 3 months |