Clinical study of alpha-GalactosylCeramide-pulsed dendritic cells and natural killer T (NKT) cells in patients with head and neck cancer

UMIN ID: UMIN000000722

Registered date:30/06/2007

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: 2005/07/01
• Target sample size: 14
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): In the patients with distant metastasis, intra-venous and sub-mucosal injections of alpha-GalactosylCeramide pulsed DCs are performed at 1, 2, 7 and 8 weeks after the entry. In the patients with local recurrence, sub-mucosal injections of alpha-GalactosylCeramide pulsed DCs are performed on day 7 and 13, and activated NKT cells is infused intra-arterially on day 14 after the entry.

Outcome(s)

• Primary Outcome: Immunological response
• Secondary Outcome: Safety, Clinical response

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: Patients who have: been treated with previous therapy of at least 4 weeks; uncontrolled diabetes mellitus, interstitial pneumonia, pleural effusion, ascites and/or pericardial effusion; 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; other cancers; 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
• Source(s) of Monetary Support: The Ministry of Education, Culture, Sports, Science and Technology