Unique ID issued by UMIN | UMIN000011508 |
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Receipt number | R000013468 |
Scientific Title | The phase I study of the combined immunotherapy using alpha-galactosylceramide pulsed antigen presenting cells and tumor-specific peptide pulsed dendritic cells for patients with advanced head and neck mucosal melanoma |
Date of disclosure of the study information | 2013/08/18 |
Last modified on | 2015/03/17 21:44:59 |
The phase I study of the combined immunotherapy using alpha-galactosylceramide pulsed antigen presenting cells and tumor-specific peptide pulsed dendritic cells for patients with advanced head and neck mucosal melanoma
The phase I study with alpha-GalCer pulsed APCs and tumor peptide pulsed DCs for head and neck mucosal melanoma
The phase I study of the combined immunotherapy using alpha-galactosylceramide pulsed antigen presenting cells and tumor-specific peptide pulsed dendritic cells for patients with advanced head and neck mucosal melanoma
The phase I study with alpha-GalCer pulsed APCs and tumor peptide pulsed DCs for head and neck mucosal melanoma
Japan |
Head and neck mucosal malignant melanoma
Oto-rhino-laryngology |
Malignancy
NO
To assess the feasibility of the combined immuntherapy using alpha-galactosylceramide pulsed antigen presenting cells and tumor-specific peptide pulsed dendritic cells for the patients with advanced head and neck mucosal malignant melanoma.
Safety
Safety profile
Interventional
expanded access
Non-randomized
Open -no one is blinded
Uncontrolled
3
Treatment
Vaccine |
The injections of 100 millions of alpha-GalCer pulsed APCs and 0.5 millions of peptide pulsed DCs on day 7 into nasal submucosa.
The injections of 100 millions of alpha-GalCer pulsed APCs and 1 millions of peptide pulsed DCs on day 7 into nasal submucosa.
The injections of 100 millions of alpha-GalCer pulsed APCs and 5 millions of peptide pulsed DCs on day 7 into nasal submucosa.
20 | years-old | <= |
80 | years-old | >= |
Male and Female
Advanced head and neck mucosal malignant melanoma; untreatable; HLA-A*2402 positive; pathological diagnosis of melanoma; ; Performance status is 0-2; Normal bone marrow and liver functions; written informed concent
Past histry of hepatitis; a positive response for HBs antigen/HCT antibody/HIV antibody/HTL-V1 antibody; recieived concurrent corticosteroid therapy; pregnancy or lactation; antoimmune disease; infection; uncontrolled diabetes mellitus; pulmonary fibrosis; serious cardiac disease; double cancer; large pleural effusions: brain metastasis judgement of physician
9
1st name | |
Middle name | |
Last name | Yoshitaka Okamoto |
Graduate School of Medicine, Chiba University
Department of Otorynolaryngology, Head and Neck Surgery
1-8-1 Inohana, Chuo-ku, Chiba
1st name | |
Middle name | |
Last name |
Chiba University Hospital
Center for Advanced Medicine
http://www.ho.chiba-u.ac.jp/future/
Department of Otorynolaryngology, Head and Neck Surgery
The Ministry of Education, Culture, Sports, Science and Technology
Japan
NO
千葉大学医学部附属病院(千葉県)
2013 | Year | 08 | Month | 18 | Day |
Unpublished
Completed
2013 | Year | 05 | Month | 15 | Day |
2013 | Year | 08 | Month | 19 | Day |
2013 | Year | 08 | Month | 18 | Day |
2015 | Year | 03 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013468
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