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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Shiga University
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Evaluation of safety: the number of adverse events of vaccination therapy.
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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*2402
- •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
Arms & Interventions
Vaccine
HLA-A*2402restricted URLC10, CDCA1, and KIF20A peptides with adjuvant
Intervention: HLA-A*2402restricted URLC10, CDCA1, and KIF20A peptides with adjuvant (Biological)
Outcomes
Primary Outcomes
Evaluation of safety: the number of adverse events of vaccination therapy.
Time Frame: 2 months
Evaluation of clinical efficacy: Objective response rate.
Time Frame: 2 months
Evaluation of clinical efficacy: Progression free survival.
Time Frame: 2 months
Evaluation of clinical efficacy: Tumor markers.
Time Frame: 2 months
Evaluation of clinical efficacy: Overall survival.
Time Frame: 2 months
Secondary Outcomes
- Various immunological responses comprising peptides specific CTL, antigen cascade, regulatory T cells, cancer antigens and HLA levels(2 months)
Investigators
Yataro Daigo
Professor
Shiga University