UMIN-CTR Clinical Trial

Basic information
Public title	The phase I/II study of the adjuvant therapy using alpha-galactosylceramide pulsed dendritic cells for patients with advanced high-grade salivary gland tumor followed by standard therpies.
Acronym	The phase I/II study of the adjuvant therapy using alpha-GalCer pulsed DCs for salivary gland tumor.
Scientific Title	The phase I/II study of the adjuvant therapy using alpha-galactosylceramide pulsed dendritic cells for patients with advanced high-grade salivary gland tumor followed by standard therpies.
Scientific Title:Acronym	The phase I/II study of the adjuvant therapy using alpha-GalCer pulsed DCs for salivary gland tumor.
Region	Japan

Condition
Condition	Salivary gland 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 dendritic 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
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Phase I: Safety profile Phase II: Two-year overall survival
Key secondary outcomes	Evaluation of peripheral iNKT cell specific immune response

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 DCs 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	1) 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. 2) Within 3 months after preceding therapies. 3) 20~80 years old. 4) Performance status is 0 or 1 5) Normal bone marrow, liver and renal functions. 6) Written informed concent.
Key exclusion criteria	1) Past history of hepatitis. 2) A positive response for HBs antigen/HCV antibody/HIV antibody/HTL-V1 antibody. 3) Concurrent corticosteroid therapy. 4) Pregnancy or lactation. 5) Autoimmune disease. 6) Sever infection 7) Uncontrolled DM. 8) Sever pulmonary emphysema or fibrosis. 9) Serious cardiac disease. 10) Double cancer. 11) Hypersensitivity for albumin 12) Judgement of physician.
Target sample size	6

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yoshitaka Okamoto
Organization	Chiba University Hospital
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 Fumie Ihara
Organization	Chiba University Hospital
Division name	Center of Advanced Medicine
Zip code
Address	1-8-1 Inohana, Chuo-ku, Chiba
TEL	043-226-2718
Homepage URL
Email	fumiko_ibaaa@yahoo.co.jp

Sponsor
Institute	Chiba University Hospital
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

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

Other administrative information
Date of disclosure of the study information	2016 Year 11 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	2016 Year 11 Month 01 Day
Date of IRB	2016 Year 11 Month 01 Day
Anticipated trial start date	2016 Year 11 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	2016 Year 11 Month 01 Day
Last modified on	2020 Year 08 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028376