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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Open Label, Non-Randomized, Safety/Efficacy study: patients will be vaccinated subcutaneously once a week with HLA-A\*2402restricted URLC10, CDCA1, and KIF20A peptides with adjuvant.
Shiga University of Medical Science Hospital
Ōtsu, Shiga, Japan
Evaluation of safety: the number of adverse events of vaccination therapy.
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
Evaluation of clinical efficacy: Objective response rate.
Time frame: 2 months
Various immunological responses comprising peptides specific CTL, antigen cascade, regulatory T cells, cancer antigens and HLA levels
Time frame: 2 months
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