bladder cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Pathologically confirmed urothelial carcinoma 2) Ta or T1 N0 M0 bladder cancer 3) Survivin-expressing tumor 4) HLA-A*2402 5) ECOG PS (Performance Status) 0-3 6) No organ failure (WBC >= 3000 cells/mm3, Hemoglobin >= 8.0 g/d, Platelet >= 10x10e4/mm3, Serum creatinine <= 2.0, Total bilirubin <=1.5, AST and ALT <= 2 x ULN 7) No previous chemotherapy, immunotherapy or radiotherapy within a month 8) Signed and dated informed consent indicating that the patient has been informed of all pertinent aspects of the trial prior to enrollment
Exclusion criteria
Exclusion criteria: 1) Coexistence of other malignancy 2) Immunodeficiency or history of splenectomy 3) Intake of steroids or immunosuppressants 4) Severe heart disease, active infection, coagulation disorder 5) Under anticoagulant therapy 6) Pregnant woman 7) Lactating woman 8) Hope to have a children 9) No willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures 10) History of severe drug allergy 11) History of severe drug-induced hepatic or renal dysfunction
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Induction of epitope-specific T cell immunity | — |
Primary
| Measure | Time frame |
|---|---|
| Recurrence-free survival | — |
Countries
Japan
Contacts
Sapporo Medical University School of Medicine Department of Urology