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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009662
Receipt No. R000011331
Scientific Title The project to investigate mTOR inhibitor-induced immune modulation in subjects with renal cell cancer.
Date of disclosure of the study information 2013/01/01
Last modified on 2017/04/30

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Basic information
Public title The project to investigate mTOR inhibitor-induced immune modulation in subjects with renal cell cancer.
Acronym Japanese m-TOR Immune Modulation Trial(J-TORIM)
Scientific Title The project to investigate mTOR inhibitor-induced immune modulation in subjects with renal cell cancer.
Scientific Title:Acronym Japanese m-TOR Immune Modulation Trial(J-TORIM)
Region
Japan

Condition
Condition advanced renal cell carcinoma
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate temsirolimus-induced immune modulation relevant to clinical efficacy or adverse events in subjects with RCC.
Basic objectives2 Others
Basic objectives -Others To investigate temsirolimus-induced immune modulation relevant to tumor response (Objective Response Rate, ORR), progression free survival(PFS) and overall survival(OS).
To investigate temsirolimus-induced immune modulation relevant to adverse events on the lungs(ie. Interstitial Lung Disease, ILD) or other than ILD.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes on the immune-relevant parameter by temsirolimus-induced immune modulation.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.Unresectable or metastatic renal carcinoma patients who were diagnosed from the results of cytological or pathological studies.
2.Patients who had more than one measurable lesions according on CT or MR imaging to the Response Evaluation Criteria in Soild Tumors (RECISTv.1.1).
3.Patients with aged 18 and over.
4.Patients with performance status 0-1 (ECOG).
5.Patients who does not observe a stromal shade in a lung by thorax CT.
6.Patients with an appropriate major organ function (liver, kidney, and myeloid).
7.Patients who meets all the following standards.
FBS<=1.5 x ULN
Total cholesterol<=400mg/dL
Trigliceride<=5.0 x ULN
8.Patients with expected survival for 3 months or longer.
9.Patients with written informed consent from the patient (In the case of underage, from both the patient himself and legally acceptable representative ).

7.Patients who meets all the following standardses.
FBS<=1.5 x ULN
Total cholesterol<=400mg/dL
Trigliceride<=5.0 x ULN
8.Patients with expected survival for 3 months or longer.
9.Patients with written informed consent from the patient.
Key exclusion criteria 1.Patients with known hypersensitivity to temsirolimus or its metabolites (including sirolimus).
2.Female patients of childbearing potential (including male patients of planning to childbear ) and becoming pregnant.
3.Patients treated with m-TOR inhibitor or performed prior immunotherapy within 6 months.
4.Patients treated with systemic steroidal therapy or immunosuppressive drug.
5.Patients with brain metastasis.
6.Patients with active double cancers.
7.Patients with active infectious disease.
8.In addition, patients whom a doctor in judge unsuitable as a candidate patients of an examination.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masatoshi Eto
Organization Faculty of Life Sciences, Kumamoto University
Division name Department of Urology
Zip code
Address Honjo 1-1-1 Kumamoto City, Kumamoto, Japan
TEL 096-344-2111
Email info2@cres-kyushu.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshihiro Wada
Organization Faculty of Life Sciences, Kumamoto University
Division name Honjo 1-1-1 Kumamoto City, Kumamoto, Japan
Zip code
Address Honjo 1-1-1 Kumamoto City, Kumamoto, Japan
TEL 096-344-2111
Homepage URL
Email yoshiwad@kumamoto-u.ac.jp

Sponsor
Institute Departmentof Urology, Faculty of Life Sciences, Kumamoto University
Institute
Department

Funding Source
Organization Departmentof Urology, Faculty of Life Sciences, Kumamoto University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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 熊本大学大学院生命科学研究部(熊本県)
札幌医科大学病院(北海道)
弘前大学大学院医学研究科(青森県)
広島市立安佐市民病院(広島県)
浜松医科大学医学部(静岡県)
岩手医科大学医学部(岩手県)
九州大学大学院医学研究院(福岡県)
東北大学大学院医学系研究科(宮城県)
奈良県立医科大学(奈良県)
徳島大学大学院(徳島県)
防衛医科大学校(埼玉県)
宮崎大学医学部(宮崎県)
大阪大学大学院医学研究科(大阪府)
四国がんセンター(愛媛県)
山形大学医学部(山形県)
山口大学大学院医学系研究科(山口県)
北海道大学大学院医学研究科(北海道)
京都大学大学院医学研究科(京都府)

Other administrative information
Date of disclosure of the study information
2013 Year 01 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 Completed
Date of protocol fixation
2012 Year 10 Month 26 Day
Date of IRB
Anticipated trial start date
2013 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information 1.Samples: peripheral blood mononuclear cells taken from the patients.
Serial sampling is required as follows;
1)Just before starting temsirolimus. In cases after TKI (sorafenib, sunitinib, axitinib), wash-out time of at least 2 weeks is necessary.
2)Early phase of treatment with temsirolimus (Three - five weeks after the starting of treatment with temsirolimus).
3)(option) Just after the occurrence of abnormal findings on chest imaging (In the case of necessity of the treatment to ILD, before the treatment).
4)(option) At the resolution phase of ILD (In the case of lack of improvement within 2 weeks, 2 weeks after the onset of ILD).

2.Item for measures:
1)Proliferation activity of T cells, assessed by tritium thymidine uptake stimulated by ConA.
2)The expression profiles of B7-H1 on CD3+, CD4+T cells and CD3+, CD8+T cells.
3)The expression profiles of PD-1 on CD3+, CD4+T cells and CD3+, CD8+T cells.
4)The ratio of Foxp3+CD4+CD25+regulatory T cells in the total CD4+CD25+T cells.
*2) to 4) are assessed by flow cytometry
5) Production of IFN-gamma and IL-6 from LPS-stimulated PBMCs, assessed by ELISA.

Management information
Registered date
2012 Year 12 Month 28 Day
Last modified on
2017 Year 04 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011331

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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