Advanced or recurrent urothelial cancer
Conditions
Interventions
Survivin-2B peptide vaccination at a dose of 1.0mg once and IFN-alpha at a dose of 300 million-unit twice every 2 weeks
Sponsors
Department of Urology, Sapporo Medical University School of Medicine
Department of Pathology, Sapporo Medical University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients enrolled in this study were required to conform to the following criteria: (1) to have histologically confirmed urothelial cancer, (2) to be HLA-A*2402 positive, (3) to be survivin- and HLA class I-positive in the carcinomatous lesions by immunohistochemistry, (4) to be between 20 and 85 years old, (5) to have received of surgical excision of the primary tumor and (6) to have Eastern Cooperative Oncology Group (ECOG) performance status between 0 and 3.
Exclusion criteria
Exclusion criteria: Exclusion criteria included (1) prior cancer therapy such as chemotherapy, radiation therapy, steroid therapy, or other immunotherapy within the previous 4 weeks, (2) the presence of other cancers that might influence the prognosis, (3) immunodeficiency or a history of splenectomy, (4) severe cardiac insufficiency, acute infection, or hematopoietic failure and (5) unsuitability for the trial based on clinical judgment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of adverse effect | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of immunological and clinical responses. Immunological responses are investigated by DTH, tetramer staining, and ELISPOT assay. Clinical responses are evaluated by RECIST criteria. | — |
Countries
Japan
Contacts
Public ContactToshiaki Tanaka
Sapporo Medical University Department of Urology
Outcome results
None listed