UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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 a carbon ion radiotherapy.
Title of the study (Brief title)	The phase II study using alpha-GalCer pulsed APCs for patients with head and neck mucosal melanoma followed by a carbon ion radiotherapy.
Region	Japan

Condition
Condition	Head and neck mucosal malignant melanoma
Classification by specialty	Oto-rhino-laryngology Radiology
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 mucosal malignant melanoma followed by a carbon ion radiotherapy.
Basic objectives2	Safety,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 14 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	Head and neck mucosal malignant melanoma patients who completed the carbon ion radiotherapy concomitant with chemotherapy; pathological diagnosis of melanoma; Life-expectancy is more than 6 months; Performance status is 0 or 1; Normal bone marrow, liver and renal functions; Detectable NKT cells in peripheral blood.
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	50

Research contact person
Name of lead principal investigator	Yoshitaka Okamoto
Organization	Graduate School of Medicine, Chiba University
Division name	Department of Otorynolaryngology
Address	1-8-1 Inohana, Chuo-ku, Chiba
TEL	043-222-7171
Email

Public contact
Name of contact person
Organization	Chiba University Hospital
Division name	Center for Advanced Medicine
Address
TEL
Homepage URL	http://www.ho.chiba-u.ac.jp/future/
Email

Sponsor
Institute	Department of Otorhinolaryngology, 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
Nationality of Funding Organization	Japan

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

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	2012 Year 11 Month 29 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 11 Month 21 Day
Anticipated trial start date	2012 Year 11 Month 29 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 11 Month 29 Day
Last modified on	2019 Year 01 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011081