UMIN-CTR Clinical Trial
| 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 |
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Basic information
Public 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.
Acronym
Chiba NKT therapy for HNSCC
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.
Scientific Title:Acronym
Chiba NKT therapy for HNSCC
Region
| Japan |
Condition
Condition
Head and neck squamous cell carcinoma
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
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.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Recurrence-free survival
Key secondary outcomes
Two-year recurrence-free survival
Two-year overall survival
Evaluation of NKT cell specific immune response
Safety profile
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Vaccine |
Interventions/Control_1
The injections of 100 million of alpha-GalCer pulsed APCs on day 7 and 10 into nasal submucosa.
Interventions/Control_2
The injections of 100 million of untreated APCs on day 7 and 14 into nasal submucosa.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
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.
Key exclusion criteria
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
Target sample size
66
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshitaka Okamoto |
Organization
Chiba University Hospital
Division name
Department of Otorhinolaryngology, Head and Neck Surgery
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL
043-222-7171
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Chiba University Hospital
Division name
Center for Advanced Medicine
Zip code
Address
TEL
Homepage URL
http://www.ho.chiba-u.ac.jp/future/en/index.html
Sponsor or person
Institute
Chiba University Hospital
Institute
Department
Personal name
Funding Source
Organization
Chiba University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2012 | Year | 12 | Month | 21 | Day |
Date of IRB
| 2013 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 12 | Month | 21 | Day |
Last modified on
| 2020 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011266
