UMIN ID: UMIN000000852
Registered date:30/06/2008
Clinical study of alpha-GalactosylCeramide-pulsed dendritic cells and natural killer T (NKT) cells in patients with operable recurrent head and neck cancer
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Head and neck squamous cell carcinoma |
| Date of first enrollment | 2007/11/01 |
| Target sample size | 13 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | 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. |
Outcome(s)
| Primary Outcome | Clinical responses |
|---|---|
| Secondary Outcome | Histopathological decisions of clinical responses, NKT cell specific immunological responses in the tissue and peripheral blood, Frequency of adverse events, Disease free survivals |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 80years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude 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 |
Related Information
| Primary Sponsor | Department of Otorhinolaryngology, Head and Neck Surgery, Graduate School of Medicine, Chiba University |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | The Ministry of Education, Culture, Sports, Science and Technology |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Shigetoshi Horiguchi |
| Address | 1-8-1 Inohana, Chuo-ku, Chiba, Japan Japan |
| Telephone | 043-226-2137 |
| Affiliation | Graduate School of Medicine, Chiba University Department of Otorhinolaryngology, Head and Neck Surgery |
| scientific contact | |
| Name | Yoshitaka Okamoto |
| Address | 1-8-1 Inohana, Chuo-ku, Chiba, Japan Japan |
| Telephone | 043-226-2137 |
| Affiliation | Graduate School of Medicine, Chiba University Department of Otorhinolaryngology, Head and Neck Surgery |