Head and Neck Malignant Melanoma
Conditions
Interventions
Sub-mucosal administrations of alpha-GalactosylCeramide pulsed DCs are performed on day 7, 14, 56 and day63 after the entry.
Sponsors
Department of Otorhinolaryngology, Head and Neck Surgery, Graduate School of Medicine, Chiba University
National Institute of Radiological Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with head and neck malignant melanoma, who have received with the Charged Particle Radiotherapy and DAV(DITC, ACNU, VCR)-Chemotherapy; Patients whose life-expectancy is more than 6 months; Performance status 0-2; 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: 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 |
|---|---|
| Safety | — |
Secondary
| Measure | Time frame |
|---|---|
| The clinical effects and immunological responses | — |
Countries
Japan
Contacts
Public ContactShigetoshi Horiguchi
Graduate School of Medicine, Chiba University epartment of Otorhinolaryngology, Head and Neck Surgery
Outcome results
None listed