Unique ID issued by UMIN | UMIN000011509 |
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Receipt number | R000013339 |
Scientific Title | The phase I/II study of the adjuvant therapy using alpha-galactosylceramide pulsed antigen presenting cells for patients with high-grade salivary grand tumor followed by standard therpies. |
Date of disclosure of the study information | 2013/08/18 |
Last modified on | 2016/11/01 14:08:07 |
The phase I/II study of the adjuvant therapy using alpha-galactosylceramide pulsed antigen presenting cells for patients with high-grade salivary grand tumor followed by standard therpies.
The phase I/II study of the adjuvant therapy using alpha-galactosylceramide pulsed antigen presenting cells for patients with salivary grand tumor.
The phase I/II study of the adjuvant therapy using alpha-galactosylceramide pulsed antigen presenting cells for patients with high-grade salivary grand tumor followed by standard therpies.
The phase I/II study of the adjuvant therapy using alpha-galactosylceramide pulsed antigen presenting cells for patients with salivary grand tumor.
Japan |
High-grade salivary grand tumor
Oto-rhino-laryngology |
Malignancy
NO
To assess the feasibility and efficacy of alpha-galactosylceramide pulsed antigen presenting cells as an adjuvant therapy for the patients with high-grade salivary grand tumor followed by standard therapies.
Safety,Efficacy
Exploratory
Pragmatic
Phase I,II
Safety profile
Evaluation of NKT cell specific immune response
Two-year recurrence-free survival
Two-year overall survival
Recurrence-free survival
Safety profile
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Vaccine |
The injections of 100 million of alpha-GalCer pulsed APCs on day 7 and 14 into nasal submucosa.
20 | years-old | <= |
80 | years-old | >= |
Male and Female
Stage IV salivary grand tumor; pathological diagnosis of mucoepidermoid carcinoma/adenoid cystic carcinoma/salivary duct carcinoma/adenocarcinoma/Carcinoma ex-pleomorphic adenoma; completed the standard therapies; Performance status is 0 or 1; Normal bone marrow, liver and renal 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, 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
043-222-7171
yokamoto@faculty.chiba-u.jp
1st name | |
Middle name | |
Last name | Naoki KUnii |
Chiba University Hospital
Center of Advanced Medicine
1-8-1 Inohana, Chuo-ku, Chiba
043-2262718
http://www.ho.chiba-u.ac.jp/future/
kunii@chiba-u.jp
Department of Otorynolaryngology, Head and Neck Surgery, Graduate School of Medicine, Chiba University
The Ministry of Education, Culture, Sports, Science and Technology
Japanese Governmental office
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 | 06 | Month | 11 | Day |
2013 | Year | 08 | Month | 18 | Day |
2013 | Year | 08 | Month | 18 | Day |
2016 | Year | 11 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013339
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