UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Combination therapy of IFN plus IL-2 for patients with mRCC after failed molecular targeted therapy
Title of the study (Brief title)	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	Haruhito Azuma
Organization	Osaka Medical College
Division name	Urology
Address	Daigaku-cho, 2-7, Takatsuki, Osaka, 569-8686 JAPAN
TEL	072-683-1221
Email	uro004@poh.osaka-med.ac.jp

Public contact
Name of contact person	Teruo Inamoto
Organization	Osaka Medical College
Division name	Urology
Address	Daigaku-cho, 2-7, Takatsuki, Osaka, 569-8686 JAPAN
TEL	072-683-1221
Homepage URL
Email	tinamoto@poh.osaka-med.ac.jp

Sponsor
Institute	Osaka Medical College
Institute
Department

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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 03 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018241