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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009431
Receipt No. R000011085
Scientific Title A phase I study of combined immunotherapy using alpha-galactosylceramide pulsed antigen presenting cells and autologous lymphocyte activated by autologous tumor tissue for patients with head and neck squamous cell carcinoma.
Date of disclosure of the study information 2012/11/29
Last modified on 2015/03/17

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Basic information
Public title A phase I study of combined immunotherapy using alpha-galactosylceramide pulsed antigen presenting cells and autologous lymphocyte activated by autologous tumor tissue for patients with head and neck squamous cell carcinoma.
Acronym A phase I study of combined immunotherapy using alpha-GalCer pulsed APCs and activated autologous lymphocyte for patients with HNSCC.
Scientific Title A phase I study of combined immunotherapy using alpha-galactosylceramide pulsed antigen presenting cells and autologous lymphocyte activated by autologous tumor tissue for patients with head and neck squamous cell carcinoma.
Scientific Title:Acronym A phase I study of combined immunotherapy using alpha-GalCer pulsed APCs and activated autologous lymphocyte for patients with 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 confirm the safety of combined immunotherapy with alpha-galactosylceramide puised antigen presenting cells and cytotoxic T lymphocytes activated by autologous tumor tissue.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes Safety profile
Key secondary outcomes Evaluation of peripheral NKT cell specific immune response
Clinical respose
Recurrence free survival

Base
Study type Interventional

Study design
Basic design Factorial
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Vaccine
Interventions/Control_1 An injection of 100 million of alpha-GalCer pulsed APCs into nasal submucosa on day 18 and an intravenous administration of 10 million of CTLs activated by autologous tumor on day 21.
Interventions/Control_2 An injection of 100 million of alpha-GalCer pulsed APCs into nasal submucosa on day 18 and an intravenous administration of 100 million of CTLs activated by autologous tumor on day 21.
Interventions/Control_3 An injection of 100 million of alpha-GalCer pulsed APCs into nasal submucosa on day 18 and an intravenous administration of 1 billion of CTLs activated by autologous tumor on day 21.
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 or recurrent head and neck squamous cell calcinoma; Obtainable tumor tisse; 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, invasion into carotid artery, pleural effusion, brain metastasis, nutritional disorder, 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
Zip code
Address Department1-8-1 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 Graduate School of Medicine, Chiba University, Department of Otorynolaryngology
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 10 Month 02 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
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=R000011085

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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