Unique ID issued by UMIN | UMIN000000722 |
---|---|
Receipt number | R000000858 |
Scientific Title | Clinical study of alpha-GalactosylCeramide-pulsed dendritic cells and natural killer T (NKT) cells in patients with head and neck cancer |
Date of disclosure of the study information | 2007/06/30 |
Last modified on | 2008/05/24 12:07:22 |
Clinical study of alpha-GalactosylCeramide-pulsed dendritic cells and natural killer T (NKT) cells in patients with head and neck cancer
Clinical study of alpha-GalactosylCeramide-pulsed dendritic cells and natural killer T (NKT) cells in patients with head and neck cancer
Clinical study of alpha-GalactosylCeramide-pulsed dendritic cells and natural killer T (NKT) cells in patients with head and neck cancer
Clinical study of alpha-GalactosylCeramide-pulsed dendritic cells and natural killer T (NKT) cells in patients with head and neck cancer
Japan |
Head and neck squamous cell carcinoma
Oto-rhino-laryngology |
Malignancy
NO
The feasibility of alpha-GalactosylCeramide-pulsed dendritic cell and natural killer T (NKT) cell immunotherapy in patients with head and neck squamous cell carcinoma are examined. The immunological responses and anti-tumor effects are also investigated.
Safety,Efficacy
Exploratory
Explanatory
Phase I,II
Immunological response
Safety, Clinical response
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine | Maneuver |
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.
20 | years-old | <= |
80 | years-old | >= |
Male and Female
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 and expanded more than 100 times in vitro.
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.
14
1st name | |
Middle name | |
Last name | Yoshitaka Okamoto |
Graduate School of Medicine, Chiba University
Department of Otorhinolaryngology, Head and Neck Surgery
1-8-1 Inohana, Chuo-ku, Chiba, Japan
043-226-2137
1st name | |
Middle name | |
Last name |
Graduate School of Medicine, Chiba University
Department of Otorhinolaryngology, Head and Neck Surgery
1-8-1 Inohana, Chuo-ku, Chiba, Japan
043-226-2137
Department of Otorhinolaryngology, Head and Neck Surgery, Graduate School of Medicine, Chiba University
The Ministry of Education, Culture, Sports, Science and Technology
Japan
NO
2007 | Year | 06 | Month | 30 | Day |
Unpublished
Completed
2005 | Year | 05 | Month | 09 | Day |
2005 | Year | 07 | Month | 01 | Day |
2007 | Year | 06 | Month | 01 | Day |
2007 | Year | 10 | Month | 01 | Day |
2007 | Year | 10 | Month | 01 | Day |
2007 | Year | 11 | Month | 01 | Day |
2007 | Year | 05 | Month | 23 | Day |
2008 | Year | 05 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000858
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |