Safety Study of Peptide Cancer Vaccine To Treat HLA-A*24-positive Advanced Small Cell Lung Cancer

The investigators previously identified three novel HLA-A*2402-restricted epitope peptides, which were derived from two cancer-testis antigens, CDCA1 and KIF20A, as targets for cancer vaccination against lung cancer. In this phase I trial, the investigators examine using a combination of these two peptides the safety, immunogenicity, and antitumor effect of vaccine treatment for HLA-A*2402-positive advanced small cell lung cancer patients who failed to standard therapy.

Inclusion criteria

• SCLC that can not undergo curative surgery and treatment, and is refractory to standard chemotherapy and radiotherapy
• 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 4 weeks
• 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