UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001772 |
|---|---|
| Receipt number | R000002097 |
| Scientific Title | The clinical study on immunotherapy for advanced renal cell carcinoma =Combination therapy of natural IFN-alfa and meloxicam against metastatic renal cell crcinoma= |
| Date of disclosure of the study information | 2009/03/13 |
| Last modified on | 2009/03/13 17:49:09 |
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Basic information
Public title
The clinical study on immunotherapy for advanced renal cell carcinoma
=Combination therapy of natural IFN-alfa and meloxicam against metastatic renal cell crcinoma=
Acronym
Combination therapy with meloxicam, a COX-2 inhibitor, and interferon alfa for metastatic renal cell carcinoma
Scientific Title
The clinical study on immunotherapy for advanced renal cell carcinoma
=Combination therapy of natural IFN-alfa and meloxicam against metastatic renal cell crcinoma=
Scientific Title:Acronym
Combination therapy with meloxicam, a COX-2 inhibitor, and interferon alfa for metastatic renal cell carcinoma
Region
| Japan |
Condition
Condition
metastatic renal cell carcinoma
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the clinical efficacy of combined therapy with natural IFN-alfa and Meloxicam in renal cell carcinoma patients with distant metastasis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
response rate
Key secondary outcomes
time to progression
overall 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
the subcutaneous injection of natural IFN-alfa at 3 mllion unit (MU) or 5 MU three times weekly plus oral administration of meloxicam (Morbic) at 10 mg once daily
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
| 15 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.patients with untreated renal carcinoma who were diagnosed from the results of imaging or pathological studies
2.patients who had measurable lesions according to the Response Evaluation Criteria in Soild Tumors (RECIST)
3. PS 0-2 (ECOG)
4. Patients with the absence of cardiac, hepatic, renal, or bone marrow dysfunction
5. Patients with expected survival for 3 months or longer
6. written informed consent from the patient
Key exclusion criteria
1. prior immunotherapy
2. Brain metastasis
3. Bone metastasis alone
4. active double cancers
5. Liver cirrhosis
6. uncontolled DM
7. Depression
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsuya Nonomura |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of renal and genitourinary surgery
Zip code
Address
North-15, West-7, Kitaku, Sapporo
TEL
011-706-5966
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuo Shinohara |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of renal and genitourinary surgery
Zip code
Address
North-15, West-7, Kitaku, Sapporo
TEL
011-706-5965
Homepage URL
nobuo-s@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido Advanced Renal Cell Carcinoma Treatment Group
Institute
Department
Personal name
Funding Source
Organization
Department of renal and genitourology surgery, Hokkaido University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
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
| 2009 | Year | 03 | Month | 13 | 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
The combination of IFN-alfa and meloxicam is considered to be an effective therapy that achieves a higher response rate compared with that previously reported for IFN- monotherapy.
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
| 2004 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2004 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2008 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2008 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2009 | Year | 02 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 03 | Month | 13 | Day |
Last modified on
| 2009 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002097
