UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015695 |
|---|---|
| Receipt number | R000018241 |
| Scientific Title | Combination therapy of IFN plus IL-2 for patients with mRCC after failed molecular targeted therapy |
| Date of disclosure of the study information | 2014/11/14 |
| Last modified on | 2017/11/16 10:14:14 |
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Basic information
Public title
Combination therapy of IFN plus IL-2 for patients with mRCC after failed molecular targeted therapy
Acronym
IFN and IL-2 for mRCC
Scientific Title
Combination therapy of IFN plus IL-2 for patients with mRCC after failed molecular targeted therapy
Scientific Title:Acronym
IFN and IL-2 for mRCC
Region
| Japan |
Condition
Condition
advaned RCC
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this research study is to determine if the combination of IFN and IL-2 is effective in treating patients with metastatic renal cell carcinoma. The safety of this combination will also be studied.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(Progression-free Survival, PFS)
Key secondary outcomes
Base
Study type
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 |
Interventions/Control_1
Drug: IFN
Drug: IL-2
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
Histologically proven mRCC
Key exclusion criteria
-allergy for IFN or IL-2
-allergy for any vaccine
-Patient using Shosaikoto (Ref. Std. Kampo Nomenclature).
-Auto-immune disease
-interstitial pneumonia
-pregnant
-long lasting steroids usage
-brain mets
-any pts doctor felt unfit the trial
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Haruhito Azuma |
Organization
Osaka Medical College
Division name
Urology
Zip code
Address
Daigaku-cho, 2-7, Takatsuki, Osaka, 569-8686 JAPAN
TEL
072-683-1221
uro004@poh.osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Teruo Inamoto |
Organization
Osaka Medical College
Division name
Urology
Zip code
Address
Daigaku-cho, 2-7, Takatsuki, Osaka, 569-8686 JAPAN
TEL
072-683-1221
Homepage URL
tinamoto@poh.osaka-med.ac.jp
Sponsor or person
Institute
Osaka Medical College
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical College
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
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
| 2014 | Year | 11 | Month | 14 | 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
| 2014 | Year | 03 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 11 | Month | 14 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 11 | Month | 14 | Day |
Last modified on
| 2017 | Year | 11 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018241
