Advanced or recurrent oral 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.
Sponsors
Department of Oral Surgery, Sapporo Medical University School of Medicine
Department of Pathology, Sapporo Medical University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically proven oral cancer, 2) HLA class I-positive and survivin-positive in the cancerous lesions by immunohistochemistry, 3) HLA-A*2402 positive, 4) unresectable advanced or recurrent oral cancer, 5) from 20-85 years old, 6) ECOG performance status between 0 and 3.
Exclusion criteria
Exclusion criteria: 1) prior cancer therapy, such as chemotherapy, radiation therapy, steroid therapy, or other immunotherapy within the past 4 weeks, 2) presence of other cancers that might influence the prognosis, 3) immunodeficiency or a history of splenectomy, 4) severe cadiac insufficiency, acute infection, or hematopoietic failure, 5) ongoing brest-feeding, 6) unsuitability for the trial based on clinical judgement.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Toxicity | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical and immunological responses. Clinical responses are evaluated by RECIST criteria and change of tumor marker levels. Immunological responses are evaluated by DTH, tetramer staining and ELISPOT assay. | — |
Countries
Japan
Contacts
Public ContactAkihiro Miyazaki
Sapporo Medical University Department of Oral Surgery
Outcome results
None listed