Safety and Efficacy Study of Epitope Peptide To Treat HLA-A*02 Disease Controlled Advanced Non-small Cell Lung Cancer

Study Overview
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Brief Summary
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The investigators previously identified a novel HLA-A*0201-restricted epitope peptide, which was derived from a cancer-testis antigen, URLC10 as a target for vaccination against lung cancer. In this clinical study, the investigators examine using the peptides the safety, immunogenicity, and antitumor effect of vaccine treatment to prevent relapse of the disease for HLA-A*0201-positive advanced non-small cell lung cancer patients whose disease are controlled after any standard therapies.

Detailed Description
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The purpose of this study is to evaluate the safety, tolerability, immune response and clinical efficacies of HLA-A*0201 restricted epitope peptides URLC10 emulsified with Montanide ISA 51 for disease controlled advanced non-small cell lung cancers. The investigators previously identified a novel HLA-A*0201-restricted epitope peptide, which was derived from a cancer-testis antigen, URLC10 as a target for cancer vaccination against lung cancer. In this phase I/II trial, the investigators examine using the peptides the safety, immunogenicity, and antitumor effect of vaccine treatment for HLA-A*0201-positive advanced non-small cell lung cancer patients whose disease are controlled after any standard therapies, but who do not have any options for additional standard ones to prevent .future relapse of the disease.

Official Title
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Phase I/II Study Using Epitope Peptide Restricted to HLA-A*24 (URLC10) in Patients With Disease Controlled Advanced Non-small Cell Lung Cancer

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Biological: HLA-A*0201restricted URLC10 peptides with adjuvant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: NSCLC whose disease are controlled after any standard therapies, but who do not have any additional standard ones to prevent .future relapse of the disease. ECOG performance status 0-2 Age between 20 to 85 Clinical efficacy can be evaluated by some methods No prior chemotherapy, radiation therapy, hyperthermia or immunotherapy within appropriate periods Life expectancy > 3 months Laboratory values as follows 1500/mm3 < WBC < 15000/mm3 Platelet count > 75000/mm3 Asparate transaminase < 3 X cutoff value Alanine transaminase < 3 X cutoff value Total bilirubin < 3 X cutoff value Serum creatinine < 2X cutoff value HLA-A*0201 Able and willing to give valid written informed consent Exclusion Criteria: Active and uncontrolled cardiac disease (i.e. coronary syndromes, arrhythmia) Myocardial infarction within six months before entry Breastfeeding and Pregnancy (woman of child bearing potential) Active and uncontrolled infectious disease Concurrent treatment with steroids or immunosuppressing agent Other malignancy requiring treatment Non-cured traumatic wound Decision of unsuitableness by principal investigator or physician-in-charge

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 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: Vaccine<br>HLA-A*0201restricted URLC10 peptides | Biological: HLA-A*0201restricted URLC10 peptides with adjuvant<br>* Open Label, Non-Randomized, Safety/Efficacy study: patients will be vaccinated subcutaneously once a week with HLA-A*0201restricted URLC10 peptides with adjuvant.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of safety: the number of adverse events of vaccination therapy. |  | 2 months | 
| Evaluation of clinical efficacy: Progression free survival. |  | 2 months | 
| Evaluation of clinical efficacy: Tumor markers. |  | 2 months | 
| Evaluation of clinical efficacy: Overall survival. |  | 2 months | 
| Evaluation of clinical efficacy: Objective response rate. |  | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Various immunological responses including peptides specific CTL, antigen cascade, regulatory T cells, cancer antigens and HLA levels. |  | 2 months |