Advanced or recurrent colorectal cancer and breast cancer
Conditions
Interventions
Survivin-2B peptide vaccination at a dose of 0.1mg every 2 weeks
Survivin-2B peptide vaccination at a dose of 1.0mg every 2 weeks
Survivin-2B peptide vaccination at a dose of 10mg every 2 weeks
Sponsors
Department of Surgery, 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 are required to conform to the following criteria: (1) to have histologically confirmed colorectal and breast cancer, (2) to be HLA-A*2402 positive, (3) to be survivin-positive in the carcinomatous lesions by immunohistochemistry, (4) to be between 20 and 85 years old, (5) to be unresectable advanced cancer or recurrent cancer, (6) to have Eastern Cooperative Oncology Group (ECOG) performance status between 0 and 3.
Exclusion criteria
Exclusion criteria: Exclusion criteria included (1) the presence of other cancers that might influence the prognosis, (2) immunodeficiency or a history of splenectomy, (3) need of steroid therapy, (4) severe cardiac insufficiency, acute infection, or hematopoietic failure, (5) prior cancer therapy such as chemotherapy, radiation therapy, steroid therapy, or other immunotherapy within the past 4 weeks, (6) ongoing breast-feeding, and (7) 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 and change of tumor marker levels. | — |
Countries
Japan
Contacts
Public ContactTetsuhiro Tsuruma
Sapporo Medical University Department of Surgery
Outcome results
None listed