Safety and Efficacy Study of Epitope Peptide To Treat HLA-A*24 or A*02-positive Advanced Solid Tumors

The purpose of this study is to evaluate the safety, tolerability, immune response and clinical efficacies of HLA-A*2402 or HLA-A*0201 restricted epitope peptides (VEGF-R1 and VEGF-R2) emulsified with Montanide ISA 51 for advanced solid tumors.

In this phase I/II trial, the investigators examine using a combination of the two peptides the safety, immunogenicity, and antitumor effect of vaccine treatment for HLA-A*2402 or HLA-A*0201-positive advanced solid tumor patients who are refractory to standard therapy.

Inclusion criteria

• Advanced solid tumors that are refractory to standard therapies or that cannot be treated with those due to medical reason.
• ECOG performance status 0-1
• Age between 20 to 85
• Clinical efficacy can be evaluated by some methods
• No prior chemotherapy, radiation therapy, hyperthermia or immunotherapy within two weeks
• Life expectancy > 3 months
• Laboratory values as follows 1500/mm3 < WBC < 10000/mm3 Platelet count > 75000/mm3 15% < Lymphcyte fraction 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 or HLA-A*0201
• 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