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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011509
Receipt No. 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

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Basic information
Public 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.
Acronym The phase I/II study of the adjuvant therapy using alpha-galactosylceramide pulsed antigen presenting cells for patients with salivary grand tumor.
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.
Scientific Title:Acronym The phase I/II study of the adjuvant therapy using alpha-galactosylceramide pulsed antigen presenting cells for patients with salivary grand tumor.
Region
Japan

Condition
Condition High-grade salivary grand tumor
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 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.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes Safety profile
Key secondary outcomes Evaluation of NKT cell specific immune response
Two-year recurrence-free survival
Two-year overall survival
Recurrence-free survival

Safety profile

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
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 14 into nasal submucosa.
Interventions/Control_2
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 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.
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 9

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshitaka Okamoto
Organization Graduate School of Medicine, Chiba University
Division name Department of Otorynolaryngology, Head and Neck Surgery
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba
TEL 043-222-7171
Email yokamoto@faculty.chiba-u.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoki KUnii
Organization Chiba University Hospital
Division name Center of Advanced Medicine
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba
TEL 043-2262718
Homepage URL http://www.ho.chiba-u.ac.jp/future/
Email kunii@chiba-u.jp

Sponsor
Institute Department of Otorynolaryngology, Head and Neck Surgery, Graduate School of Medicine, Chiba University
Institute
Department

Funding Source
Organization The Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 千葉大学医学部附属病院(千葉県)

Other administrative information
Date of disclosure of the study information
2013 Year 08 Month 18 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 Completed
Date of protocol fixation
2013 Year 06 Month 11 Day
Date of IRB
Anticipated trial start date
2013 Year 08 Month 18 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 08 Month 18 Day
Last modified on
2016 Year 11 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013339

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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