UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000852 |
|---|---|
| Receipt number | R000001023 |
| Scientific Title | Clinical study of alpha-GalactosylCeramide-pulsed dendritic cells and natural killer T (NKT) cells in patients with operable recurrent head and neck cancer |
| Date of disclosure of the study information | 2008/06/30 |
| Last modified on | 2012/11/29 14:28:29 |
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Basic information
Public title
Clinical study of alpha-GalactosylCeramide-pulsed dendritic cells and natural killer T (NKT) cells in patients with operable recurrent head and neck cancer
Acronym
Clinical study of alpha-GalactosylCeramide-pulsed dendritic cells and natural killer T (NKT) cells in patients with operable recurrent head and neck cancer
Scientific Title
Clinical study of alpha-GalactosylCeramide-pulsed dendritic cells and natural killer T (NKT) cells in patients with operable recurrent head and neck cancer
Scientific Title:Acronym
Clinical study of alpha-GalactosylCeramide-pulsed dendritic cells and natural killer T (NKT) cells in patients with operable recurrent head and neck cancer
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
The feasibility of alpha-GalactosylCeramide-pulsed dendritic cell and natural killer T (NKT) cell immunotherapy in patients with head and neck squamous cell carcinoma are examined. The clinical effects and immunological responses, safety are also investigated.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Clinical responses
Key secondary outcomes
Histopathological decisions of clinical responses, NKT cell specific immunological responses in the tissue and peripheral blood, Frequency of adverse events, Disease free survivals
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
Sub-mucosal injections of alpha-GalactosylCeramide pulsed DCs are performed on day 7, and activated NKT cells is infused intra-arterially on day 14 after the entry.
Interventions/Control_2
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
Operable recurrent head and neck squamous cell carcinoma patients who have measurable lesion; Patients whose life-expectancy is more than 6 months; Performance status 0-1; Normal bone marrow, liver and renal functions; NKT cells are detected at least 10 cells in 1 mL of peripheral blood.
Key exclusion criteria
Patients who have: been treated with previous therapy of at least 4 weeks; uncontrolled diabetes mellitus, pulmonary fibrosis, and/or infection; a history of hepatitis; a positive response for hepatitis B surface antigen, or human immunodeficiency virus (HIV), hepatitis C virus, or human T-lymphotrophic virus antibodies; serious cardiac disease; recieived concurrent corticosteroid therapy; pregnancy or lactation; autoimmune diseases; been judged to be inappropriate to participate in this study by principle investigator or co-investigator
Target sample size
13
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 Otorhinolaryngology, Head and Neck Surgery
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL
043-226-2137
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigetoshi Horiguchi |
Organization
Graduate School of Medicine, Chiba University
Division name
Department of Otorhinolaryngology, Head and Neck Surgery
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL
043-226-2137
Homepage URL
Sponsor or person
Institute
Department of Otorhinolaryngology, Head and Neck Surgery, Graduate School of Medicine, Chiba University
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
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 06 | Month | 30 | 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
| 2007 | Year | 09 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 11 | Month | 29 | Day |
Date trial data considered complete
| 2012 | Year | 11 | Month | 29 | Day |
Date analysis concluded
| 2012 | Year | 11 | Month | 29 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 10 | Month | 16 | Day |
Last modified on
| 2012 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001023
