Clinical study of alpha-GalactosylCeramide-pulsed dendritic cells in patients with advanced and recurrent lung cancer

UMIN ID: UMIN000000948

Registered date:14/12/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: primary lung cancer
• Date of first enrollment: 2004/02/01
• Target sample size: 23
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): In patients with advanced or recurrent lung cancer, intra-venous injections of alpha-GalactosylCeramide pulsed DCs are performed at 1, 2, 7 and 8 weeks after the entry.

Outcome(s)

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

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: the presence of active 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; evedence for other malignant diseases; serious cardiac disease, recieived concurrent corticosteroid therapy; pregnancy or lactation; been judged to be inappropriate to participate in this study by principle investigator or co-investigator

Related Information

• Primary Sponsor: Department of Thoracic Surgery, Graduate School of Medicine, Chiba University
• Source(s) of Monetary Support: National Institute of Biomedical Innovation