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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009430
Receipt No. R000011081
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 a carbon ion radiotherapy.
Date of disclosure of the study information 2012/11/29
Last modified on 2019/01/28

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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 a carbon ion radiotherapy.
Acronym The phase II study using alpha-GalCer pulsed APCs for patients with head and neck mucosal melanoma followed by a carbon ion radiotherapy.
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 a carbon ion radiotherapy.
Scientific Title:Acronym 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
1st name
Middle name
Last name Yoshitaka Okamoto
Organization Graduate School of Medicine, Chiba University
Division name Department of Otorynolaryngology
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba
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/
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)

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
2012 Year 11 Month 29 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
2012 Year 11 Month 21 Day
Date of IRB
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

Other
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

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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