UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017717 |
|---|---|
| Receipt number | R000020524 |
| Scientific Title | Combination therapy of interferon-alpha and interleukin-2 for patients with metastatic renal cell carcinoma after failure of targeted therapy because of adverse events |
| Date of disclosure of the study information | 2015/05/28 |
| Last modified on | 2016/01/04 19:59:42 |
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Basic information
Public title
Combination therapy of interferon-alpha and interleukin-2 for patients with metastatic renal cell carcinoma after failure of targeted therapy because of adverse events
Acronym
IFN-alpha and IL-2 therapy after failure oftargeted therapy because of adverse events
Scientific Title
Combination therapy of interferon-alpha and interleukin-2 for patients with metastatic renal cell carcinoma after failure of targeted therapy because of adverse events
Scientific Title:Acronym
IFN-alpha and IL-2 therapy after failure oftargeted therapy because of adverse events
Region
| Japan |
Condition
Condition
metastatic renal cell carcinoma
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of combination therapy of IFN-alpha and IL-2 therapy in patients who failed targeted therapy because of the adverse events
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
response rate (CR + PR + SD)
Key secondary outcomes
progression free survival
adverse events
Base
Study type
Interventional
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
Interferon alpha, interleukin 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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. metastatic renal cell carcinoma, histologically proved
2. measurable lesions
3. prior nephrectomy for primary lesion
4. failure of targeted therapy because of the adverse events
5. without failure of bone marrow, renal, liver, cardiovascular, or respiratory function
Key exclusion criteria
1. allergic reaction for biological products such as vaccine
2. autoimmune hepatitis
3. interstitial pneumonitis
4. female during pregnancy or lactation
5. receiving steroid hormone therapy
6. progressive disease during prior targeted therapy
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Haruki Kume |
Organization
The University of Tokyo Hospital
Division name
Department of Urology
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
+81-3-5800-8753
kumeh-uro@h.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Haruki Kume |
Organization
The University of Tokyo Hospital
Division name
Department of Urology
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
+81-3-5800-8753
Homepage URL
kumeh-uro@h.u-tokyo.ac.jp
Sponsor or person
Institute
Department of Urology, The University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Urology, The University of Tokyo Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
| 2015 | Year | 05 | Month | 28 | 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
Open public recruiting
Date of protocol fixation
| 2010 | Year | 03 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | Month | 06 | 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
| 2015 | Year | 05 | Month | 28 | Day |
Last modified on
| 2016 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020524
