Head and neck squamous cell carcinoma
Conditions
Interventions
Sub-mucosal injections of alpha-GalactosylCeramide pulsed DCs are performed on day 7, and activated NKT cells is infused intra-arterially on day 14 after the entry.
Sponsors
Department of Otorhinolaryngology, Head and Neck Surgery, Graduate School of Medicine, Chiba University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Operable recurrent head and neck squamous cell carcinoma patients who have measurable lesion; Patients whose life-expectancy is more than 6 months; Performance status 0-1; Normal bone marrow, liver and renal functions; NKT cells are detected at least 10 cells in 1 mL of peripheral blood.
Exclusion criteria
Exclusion criteria: Patients who have: been treated with previous therapy of at least 4 weeks; uncontrolled diabetes mellitus, pulmonary fibrosis, and/or infection; a history of hepatitis; a positive response for hepatitis B surface antigen, or human immunodeficiency virus (HIV), hepatitis C virus, or human T-lymphotrophic virus antibodies; serious cardiac disease; recieived concurrent corticosteroid therapy; pregnancy or lactation; autoimmune diseases; been judged to be inappropriate to participate in this study by principle investigator or co-investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical responses | — |
Secondary
| Measure | Time frame |
|---|---|
| Histopathological decisions of clinical responses, NKT cell specific immunological responses in the tissue and peripheral blood, Frequency of adverse events, Disease free survivals | — |
Countries
Japan
Contacts
Public ContactShigetoshi Horiguchi
Graduate School of Medicine, Chiba University Department of Otorhinolaryngology, Head and Neck Surgery
Outcome results
None listed