UMIN-CTR Clinical Trial

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
Email

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
Email

Sponsor
Institute	Chiba University Hospital
Institute
Department

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011266