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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011508
Receipt No. R000013468
Scientific Title The phase I study of the combined immunotherapy using alpha-galactosylceramide pulsed antigen presenting cells and tumor-specific peptide pulsed dendritic cells for patients with advanced head and neck mucosal melanoma
Date of disclosure of the study information 2013/08/18
Last modified on 2015/03/17

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Basic information
Public title The phase I study of the combined immunotherapy using alpha-galactosylceramide pulsed antigen presenting cells and tumor-specific peptide pulsed dendritic cells for patients with advanced head and neck mucosal melanoma
Acronym The phase I study with alpha-GalCer pulsed APCs and tumor peptide pulsed DCs for head and neck mucosal melanoma
Scientific Title The phase I study of the combined immunotherapy using alpha-galactosylceramide pulsed antigen presenting cells and tumor-specific peptide pulsed dendritic cells for patients with advanced head and neck mucosal melanoma
Scientific Title:Acronym The phase I study with alpha-GalCer pulsed APCs and tumor peptide pulsed DCs for head and neck mucosal melanoma
Region
Japan

Condition
Condition Head and neck mucosal malignant melanoma
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the feasibility of the combined immuntherapy using alpha-galactosylceramide pulsed antigen presenting cells and tumor-specific peptide pulsed dendritic cells for the patients with advanced head and neck mucosal malignant melanoma.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Safety profile
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design expanded access
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Vaccine
Interventions/Control_1 The injections of 100 millions of alpha-GalCer pulsed APCs and 0.5 millions of peptide pulsed DCs on day 7 into nasal submucosa.
Interventions/Control_2 The injections of 100 millions of alpha-GalCer pulsed APCs and 1 millions of peptide pulsed DCs on day 7 into nasal submucosa.
Interventions/Control_3 The injections of 100 millions of alpha-GalCer pulsed APCs and 5 millions of peptide pulsed DCs on day 7 into nasal submucosa.
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 Advanced head and neck mucosal malignant melanoma; untreatable; HLA-A*2402 positive; pathological diagnosis of melanoma; ; Performance status is 0-2; Normal bone marrow and liver 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; large pleural effusions: brain metastasis 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
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 Otorynolaryngology, Head and Neck Surgery
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
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 05 Month 15 Day
Date of IRB
Anticipated trial start date
2013 Year 08 Month 19 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
2015 Year 03 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013468

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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