Unique ID issued by UMIN | UMIN000009607 |
---|---|
Receipt number | R000011266 |
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 standard therapy. |
Date of disclosure of the study information | 2013/04/01 |
Last modified on | 2020/08/15 14:17:19 |
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 standard therapy.
Chiba NKT therapy for HNSCC
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 standard therapy.
Chiba NKT therapy for HNSCC
Japan |
Head and neck squamous cell carcinoma
Oto-rhino-laryngology |
Malignancy
NO
To assess the efficacy of alpha-galactosylceramide pulsed antigen presenting cells as an adjuvant therapy for the patients with head and neck squamous cell carcinoma followed by a standard therapy.
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 10 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
Stage IV HNSCC; Complete responce (CR) after first standard therapy; Within 8 weeks after the assessment of CR; Within 4 months after previous treatment; pathological diagnosis of squamous cell carcinoma; Performance status is 0 - 2; 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
66
1st name | |
Middle name | |
Last name | Yoshitaka Okamoto |
Chiba University Hospital
Department of Otorhinolaryngology, Head and Neck Surgery
1-8-1 Inohana, Chuo-ku, Chiba, Japan
043-222-7171
1st name | |
Middle name | |
Last name |
Chiba University Hospital
Center for Advanced Medicine
http://www.ho.chiba-u.ac.jp/future/en/index.html
Chiba University Hospital
Chiba University Hospital
Other
NO
2013 | Year | 04 | Month | 01 | Day |
Unpublished
Terminated
2012 | Year | 12 | Month | 21 | Day |
2013 | Year | 04 | Month | 01 | Day |
2013 | Year | 04 | Month | 01 | Day |
2019 | Year | 03 | Month | 31 | Day |
2012 | Year | 12 | Month | 21 | Day |
2020 | Year | 08 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011266