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 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 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 who failed to standard therapy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Escalating doses of every peptide will be administered by subcutaneous injection on days 1, 8, 15 and 22 of each treatment cycle. Planned doses of peptides are 1.0mg, 2.0mg and 3.0mg.
Shiga University of Medical Science Hospital
Ōtsu, Shiga, Japan
Evaluation of safety (NCI CTCAE version3): the number of adverse events of vaccination therapy.
Time frame: 2 months
Evaluation of tolerability (maximum tolerated dose, MTD and dose limiting toxicity, DLT) for the determination of the recommended dose for next phase trial.
Time frame: 2 months
Immunological responses including peptides specific CTL, antigen cascade, regulatory T cells, cancer antigens and HLA levels
Time frame: 2 months (every time point(s) at which each course is completed)
Evaluation of clinical efficacy: Objective response rate (RECIST1.1), Tumor markers, Overall survival, Progression free survival.
Time frame: 2 months (every time point(s) at which each course is completed)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.