Unique ID issued by UMIN | UMIN000001930 |
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Receipt number | R000002294 |
Scientific Title | Clinical study of alpha-GalactosylCeramide-pulsed DC therapy in Patients with Head and Neck Malignant Melanoma after the Charged Particle Radiotherapy |
Date of disclosure of the study information | 2009/05/01 |
Last modified on | 2019/03/07 17:53:33 |
Clinical study of alpha-GalactosylCeramide-pulsed DC therapy in Patients with Head and Neck Malignant Melanoma after the Charged Particle Radiotherapy
Clinical study of alpha-GalactosylCeramide-pulsed DC therapy
Clinical study of alpha-GalactosylCeramide-pulsed DC therapy in Patients with Head and Neck Malignant Melanoma after the Charged Particle Radiotherapy
Clinical study of alpha-GalactosylCeramide-pulsed DC therapy
Japan |
Head and Neck Malignant Melanoma
Oto-rhino-laryngology |
Malignancy
NO
The feasibility of alpha-GalactosylCeramide-pulsed dendritic cell immunotherapy in patients with head and neck malignant melanoma are examined. The safety, clinical effects and immunological responses are investigated.
Efficacy
Exploratory
Explanatory
Phase I,II
Safety
The clinical effects and immunological responses
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine | Maneuver |
Sub-mucosal administrations of alpha-GalactosylCeramide pulsed DCs are performed on day 7, 14, 56 and day63 after the entry.
20 | years-old | <= |
80 | years-old | >= |
Male and Female
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.
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
20
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
1st name | |
Middle name | |
Last name | Shigetoshi Horiguchi |
Graduate School of Medicine, Chiba University
epartment of Otorhinolaryngology, Head and Neck Surgery
1-8-1 Inohana, Chuo-ku, Chiba, Japan
Department of Otorhinolaryngology, Head and Neck Surgery, Graduate School of Medicine, Chiba University
The Ministry of Education, Culture, Sports, Science and Technology
Japan
National Institute of Radiological Sciences
NO
2009 | Year | 05 | Month | 01 | Day |
Published
Completed
2007 | Year | 08 | Month | 01 | Day |
2008 | Year | 04 | Month | 01 | Day |
2012 | Year | 03 | Month | 01 | Day |
2009 | Year | 05 | Month | 01 | Day |
2019 | Year | 03 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002294
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