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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001772
Receipt No. 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

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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
Email

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
Email nobuo-s@med.hokudai.ac.jp

Sponsor
Institute Hokkaido Advanced Renal Cell Carcinoma Treatment Group
Institute
Department

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
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

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-&#61537; 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002097

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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