Unique ID issued by UMIN | UMIN000001772 |
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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 |
The clinical study on immunotherapy for advanced renal cell carcinoma
=Combination therapy of natural IFN-alfa and meloxicam against metastatic renal cell crcinoma=
Combination therapy with meloxicam, a COX-2 inhibitor, and interferon alfa for metastatic renal cell carcinoma
The clinical study on immunotherapy for advanced renal cell carcinoma
=Combination therapy of natural IFN-alfa and meloxicam against metastatic renal cell crcinoma=
Combination therapy with meloxicam, a COX-2 inhibitor, and interferon alfa for metastatic renal cell carcinoma
Japan |
metastatic renal cell carcinoma
Urology |
Malignancy
NO
To investigate the clinical efficacy of combined therapy with natural IFN-alfa and Meloxicam in renal cell carcinoma patients with distant metastasis
Safety,Efficacy
Exploratory
Explanatory
Phase II
response rate
time to progression
overall survival
adverse events
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
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
15 | years-old | <= |
85 | years-old | > |
Male and Female
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
1. prior immunotherapy
2. Brain metastasis
3. Bone metastasis alone
4. active double cancers
5. Liver cirrhosis
6. uncontolled DM
7. Depression
50
1st name | |
Middle name | |
Last name | Katsuya Nonomura |
Hokkaido University Graduate School of Medicine
Department of renal and genitourinary surgery
North-15, West-7, Kitaku, Sapporo
011-706-5966
1st name | |
Middle name | |
Last name | Nobuo Shinohara |
Hokkaido University Graduate School of Medicine
Department of renal and genitourinary surgery
North-15, West-7, Kitaku, Sapporo
011-706-5965
nobuo-s@med.hokudai.ac.jp
Hokkaido Advanced Renal Cell Carcinoma Treatment Group
Department of renal and genitourology surgery, Hokkaido University Graduate School of Medicine
Self funding
NO
2009 | Year | 03 | Month | 13 | Day |
Unpublished
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.
Completed
2004 | Year | 07 | Month | 01 | Day |
2004 | Year | 07 | Month | 01 | Day |
2008 | Year | 12 | Month | 01 | Day |
2008 | Year | 12 | Month | 01 | Day |
2008 | Year | 12 | Month | 01 | Day |
2009 | Year | 02 | Month | 01 | Day |
2009 | Year | 03 | Month | 13 | Day |
2009 | Year | 03 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002097
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