UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009431 |
|---|---|
| Receipt number | 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 21:43:48 |
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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
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/
Sponsor or person
Institute
Graduate School of Medicine, Chiba University, Department of Otorynolaryngology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011085
