UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000628 |
|---|---|
| Receipt number | R000000761 |
| Scientific Title | A study to evaluate the safety and efficacy of ex vivo expanded autologous gamma/delta T cell infusion following zoledronic acid sensitization in patients who received radiotherapy for bone metastases. |
| Date of disclosure of the study information | 2007/03/05 |
| Last modified on | 2012/07/11 17:21:59 |
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Basic information
Public title
A study to evaluate the safety and efficacy of ex vivo expanded autologous gamma/delta T cell infusion following zoledronic acid sensitization in patients who received radiotherapy for bone metastases.
Acronym
A clinical study of combined radiotherapy and gamma/delta T cell therapy for born metastases
Scientific Title
A study to evaluate the safety and efficacy of ex vivo expanded autologous gamma/delta T cell infusion following zoledronic acid sensitization in patients who received radiotherapy for bone metastases.
Scientific Title:Acronym
A clinical study of combined radiotherapy and gamma/delta T cell therapy for born metastases
Region
| Japan |
Condition
Condition
Patients with bone metastatic cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the safety of ex vivo expanded autologous gamma/delta T cell infusion, as well as its efficacy in patients with bone metastases.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Adverse events
Key secondary outcomes
Antitumor effects on the metastatic foci and primary lesion; Time to progression; Improvement of tumor-related markers, and immunological parameters.
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
| Medicine |
Interventions/Control_1
Gammadelta T cell
Radiation
Zoledronate
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with bone metastatic cancer
- Performance status 0-1
- No serious abnormality in bone marrow, liver and renal functions
Key exclusion criteria
Patients who have: out-of-controlled infections, active autoimmune diseases, serious complications, other cancers, active enteritis, and symptoms of fibroid lung or interstitial pneumonia; who have received continuous systemic steroids; who are pregnant, to be pregnant, or nursing mothers, and whom principle investigator or co-investigator judged to be inappropriate to participate in this study
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keiichi Nakagawa |
Organization
University of Tokyo, Graduate School of Medicine
Division name
Radiology Course, Division of Radiology and Biomedical Engineering
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Kakimi |
Organization
University of Tokyo, Graduate School of Medicine
Division name
Department of Immunotherapeutics (medinet)
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL
03-5805-3163
Homepage URL
http://immunoth.umin.jp/index.html
immunotherapy-admin@umin.ac.jp
Sponsor or person
Institute
University of Tokyo, Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
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)
Medinet Co.,Ltd.
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
| 2007 | Year | 03 | Month | 05 | 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 | 01 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2007 | Year | 03 | Month | 02 | Day |
Last modified on
| 2012 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000761
