Unique ID issued by UMIN | UMIN000009430 |
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Receipt number | R000011081 |
Scientific Title | The double-blind, randomised controlled phase II study of the adjuvant therapy using alpha-galactosylceramide pulsed antigen presenting cells for patients with head and neck mucosal melanoma followed by a carbon ion radiotherapy. |
Date of disclosure of the study information | 2012/11/29 |
Last modified on | 2019/01/28 20:41:10 |
The double-blind, randomised controlled phase II study of the adjuvant therapy using alpha-galactosylceramide pulsed antigen presenting cells for patients with head and neck mucosal melanoma followed by a carbon ion radiotherapy.
The phase II study using alpha-GalCer pulsed APCs for patients with head and neck mucosal melanoma followed by a carbon ion radiotherapy.
The double-blind, randomised controlled phase II study of the adjuvant therapy using alpha-galactosylceramide pulsed antigen presenting cells for patients with head and neck mucosal melanoma followed by a carbon ion radiotherapy.
The phase II study using alpha-GalCer pulsed APCs for patients with head and neck mucosal melanoma followed by a carbon ion radiotherapy.
Japan |
Head and neck mucosal malignant melanoma
Oto-rhino-laryngology | Radiology |
Malignancy
NO
To assess the efficacy of alpha-galactosylceramide pulsed antigen presenting cells as an adjuvant therapy for the patients with head and neck mucosal malignant melanoma followed by a carbon ion radiotherapy.
Safety,Efficacy
Exploratory
Pragmatic
Phase II
Recurrence-free survival
Two-year recurrence-free survival
Two-year overall survival
Evaluation of NKT cell specific immune response
Safety profile
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
NO
Institution is not considered as adjustment factor.
YES
Central registration
2
Treatment
Vaccine |
The injections of 100 million of alpha-GalCer pulsed APCs on day 7 and 14 into nasal submucosa.
The injections of 100 million of untreated APCs on day 7 and 14 into nasal submucosa.
20 | years-old | <= |
80 | years-old | >= |
Male and Female
Head and neck mucosal malignant melanoma patients who completed the carbon ion radiotherapy concomitant with chemotherapy; pathological diagnosis of melanoma; Life-expectancy is more than 6 months; Performance status is 0 or 1; Normal bone marrow, liver and renal functions; Detectable NKT cells in peripheral blood.
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
50
1st name | |
Middle name | |
Last name | Yoshitaka Okamoto |
Graduate School of Medicine, Chiba University
Department of Otorynolaryngology
1-8-1 Inohana, Chuo-ku, Chiba
043-222-7171
1st name | |
Middle name | |
Last name |
Chiba University Hospital
Center for Advanced Medicine
http://www.ho.chiba-u.ac.jp/future/
Department of Otorhinolaryngology, Graduate School of Medicine, Chiba University
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)
2012 | Year | 11 | Month | 29 | Day |
Unpublished
Completed
2012 | Year | 11 | Month | 21 | Day |
2012 | Year | 11 | Month | 29 | Day |
2012 | Year | 11 | Month | 29 | Day |
2019 | Year | 01 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011081
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