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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000628
Receipt No. 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

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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
Email

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
Email immunotherapy-admin@umin.ac.jp

Sponsor
Institute University of Tokyo, Graduate School of Medicine
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000761

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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