Renal cell carcinoma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1)ECOG performance status of 0 to 1 2)Subjects with histologically or cytologically confirmed, advanced RCC 3)Subjects with nephrectomy 4)Life expectancy of at least 3 months at the date of informed consents 5)Adequate functions of major organs 6)Adequate hepatic function (AST and ALT levels < 3 times the ULN) 7)Subjects without serious electrocardiogram abnormalities 8)Subjects with written, signed, dated, and witnessed IRB/IEC approved ICF
Exclusion criteria
Exclusion criteria: 1)Subjects using Sho-saiko-to 2)Subjects with autoimmunehepatitis 3)Known hypersensitivity to interferon 4)Known hypersensitivity to biologics, such as vaccines 5)Myocardial infarction within the previous 12 months 6)Previous history of renal failure 7)Diabetes mellitus with retinopathy, nephropathy, neuropathy, or insulin-dependency 8)Active acute or chronic infection or serious intercurrent illness 9)Liver cirrhosis 10)Severe mental disorder, such as severe depression 11)Pregnant women, or women who have a possibility of pregnancy 12)Prior interferon-a treatment within 6 months before informed consent 13)CNS metastases 14)Subjects without mesurable disease 15)Any other major illness that, in the investigator's judgement, will substantially increase the risk associated with the subject's participation in this study
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1)The correlation between the antitumor effects of interferon-a and SNP allele frequencies of 10 genes(STAT3-0, SOCS3-1, IL4R-34, PTGS1-3, PTGS1-4, PTGS1-5, PTGS2-12, IRF2-67, ICSBP-38, TAP2-5). 2)The relativities between PFS, TTP, OS and CSS with SNP allele frequencies of STAT3-2, STAT3-0, SOCS3-1, IL4R-34, PTGS1-3, PTGS1-4 ,PTGS1-5, PTGS2-12, IRF2-67, ICSBP-38 and TAP2-5 genes. | — |
Primary
| Measure | Time frame |
|---|---|
| The correlation between the antitomor effects of interferon-a and SNP allele frequencies of STAT3-2 genes. | — |
Countries
Japan
Contacts
Graduate School of Medical Sciences, Kyushu University Department of Urology