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Safety and Efficacy Study of Epitope Peptide To Treat HLA-A*24 Disease Controlled Advanced Non-small Cell Lung Cancer

NCT01950156

Description:

The investigators previously identified three novel HLA-A*2402-restricted epitope peptides, which were derived from three cancer-testis antigens, URLC10, CDCA1, and KIF20A, as targets for vaccination against lung cancer. In this clinical study, the investigators examine using a combination of these three peptides the safety, immunogenicity, and antitumor effect of vaccine treatment to prevent relapse of the disease for HLA-A*2402-positive advanced non-small cell lung cancer patients whose disease are controlled after any standard therapies.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Completed

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Safety and Efficacy Study of Epitope Peptide To Treat HLA-A*24 Disease Controlled Advanced Non-small Cell Lung Cancer
  • Official Title: Phase I/II Study Using Epitope Peptide Restricted to HLA-A*24 (URLC10,CDCA1,KIF20A) in Patients With Disease Controlled Advanced Non-small Cell Lung Cancer

Clinical Trial IDs

  • ORG STUDY ID: SUMS-23-57
  • SECONDARY ID: 23-57
  • NCT ID: NCT01950156

Conditions

  • Non-small Cell Lung Cancer

Interventions

DrugSynonymsArms
HLA-A*2402restricted URLC10, CDCA1, and KIF20A peptides with adjuvantVaccine

Purpose

The investigators previously identified three novel HLA-A*2402-restricted epitope peptides, which were derived from three cancer-testis antigens, URLC10, CDCA1, and KIF20A, as targets for vaccination against lung cancer. In this clinical study, the investigators examine using a combination of these three peptides the safety, immunogenicity, and antitumor effect of vaccine treatment to prevent relapse of the disease for HLA-A*2402-positive advanced non-small cell lung cancer patients whose disease are controlled after any standard therapies.

Detailed Description

      The purpose of this study is to evaluate the safety, tolerability, immune response and
      clinical efficacies of HLA-A*2402 restricted epitope peptides URLC10, CDCA1, and KIF20A
      emulsified with Montanide ISA 51 for disease controlled advanced non-small cell lung cancers.

      The investigators previously identified three novel HLA-A*2402-restricted epitope peptides,
      which were derived from three cancer-testis antigens, URLC10, CDCA1, and KIF20A, as targets
      for cancer vaccination against lung cancer. In this phase I/II trial, the investigators
      examine using a combination of these three peptides the safety, immunogenicity, and antitumor
      effect of vaccine treatment for HLA-A*2402-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.
    

Trial Arms

NameTypeDescriptionInterventions
VaccineExperimentalHLA-A*2402restricted URLC10, CDCA1, and KIF20A peptides with adjuvant
  • HLA-A*2402restricted URLC10, CDCA1, and KIF20A peptides with adjuvant

Eligibility Criteria

        Inclusion Criteria:

          1. 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.

          2. ECOG performance status 0-2

          3. Age between 20 to 85

          4. Clinical efficacy can be evaluated by some methods

          5. No prior chemotherapy, radiation therapy, hyperthermia or immunotherapy within
             appropriate periods

          6. Life expectancy > 3 months

          7. 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

          8. HLA-A*2402

          9. Able and willing to give valid written informed consent

        Exclusion Criteria:

          1. Active and uncontrolled cardiac disease (i.e. coronary syndromes, arrhythmia)

          2. Myocardial infarction within six months before entry

          3. Breastfeeding and Pregnancy (woman of child bearing potential)

          4. Active and uncontrolled infectious disease

          5. Concurrent treatment with steroids or immunosuppressing agent

          6. Other malignancy requiring treatment

          7. Non-cured traumatic wound

          8. Decision of unsuitableness by principal investigator or physician-in-charge
      
Maximum Eligible Age:85 Years
Minimum Eligible Age:20 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Evaluation of safety: the number of adverse events of vaccination therapy.
Time Frame:2 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Various immunological responses comprising peptides specific CTL, antigen cascade, regulatory T cells, cancer antigens and HLA levels
Time Frame:2 months
Safety Issue:
Description:

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Shiga University

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