UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024669 |
|---|---|
| Receipt number | R000028376 |
| Scientific Title | The phase I/II study of the adjuvant therapy using alpha-galactosylceramide pulsed dendritic cells for patients with advanced high-grade salivary gland tumor followed by standard therpies. |
| Date of disclosure of the study information | 2016/11/01 |
| Last modified on | 2020/08/15 14:16:13 |
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Basic information
Public title
The phase I/II study of the adjuvant therapy using alpha-galactosylceramide pulsed dendritic cells for patients with advanced high-grade salivary gland tumor followed by standard therpies.
Acronym
The phase I/II study of the adjuvant therapy using alpha-GalCer pulsed DCs for salivary gland tumor.
Scientific Title
The phase I/II study of the adjuvant therapy using alpha-galactosylceramide pulsed dendritic cells for patients with advanced high-grade salivary gland tumor followed by standard therpies.
Scientific Title:Acronym
The phase I/II study of the adjuvant therapy using alpha-GalCer pulsed DCs for salivary gland tumor.
Region
| Japan |
Condition
Condition
Salivary gland tumor
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the feasibility and efficacy of alpha-galactosylceramide pulsed dendritic cells as an adjuvant therapy for the patients with high-grade salivary grand tumor followed by standard therapies.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Phase I: Safety profile
Phase II: Two-year overall survival
Key secondary outcomes
Evaluation of peripheral iNKT cell specific immune response
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Vaccine |
Interventions/Control_1
The injections of 100 million of alpha-GalCer pulsed DCs on day 7 and 14 into nasal submucosa.
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
1) Stage IV salivary grand tumor; pathological diagnosis of mucoepidermoid carcinoma/adenoid cystic carcinoma/salivary duct carcinoma/adenocarcinoma/Carcinoma ex-pleomorphic adenoma; completed the standard therapies.
2) Within 3 months after preceding therapies.
3) 20~80 years old.
4) Performance status is 0 or 1
5) Normal bone marrow, liver and renal functions.
6) Written informed concent.
Key exclusion criteria
1) Past history of hepatitis.
2) A positive response for HBs antigen/HCV antibody/HIV antibody/HTL-V1 antibody.
3) Concurrent corticosteroid therapy.
4) Pregnancy or lactation.
5) Autoimmune disease.
6) Sever infection
7) Uncontrolled DM.
8) Sever pulmonary emphysema or fibrosis.
9) Serious cardiac disease.
10) Double cancer.
11) Hypersensitivity for albumin
12) Judgement of physician.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshitaka Okamoto |
Organization
Chiba University Hospital
Division name
Department of Otorynolaryngology, Head and Neck Surgery
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba
TEL
043-222-7171
yokamoto@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fumie Ihara |
Organization
Chiba University Hospital
Division name
Center of Advanced Medicine
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba
TEL
043-226-2718
Homepage URL
fumiko_ibaaa@yahoo.co.jp
Sponsor or person
Institute
Chiba University Hospital
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
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
| 2016 | Year | 11 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 11 | Month | 01 | Day |
Last modified on
| 2020 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028376
