Renal cell carcinoma
Conditions
Interventions
Interferon Alfa-n1 monotherapy will be performed for 2 weeks. Patients will be checked for adverse event caused by Interferon Alfa-n1. Interferon Alfa-n1+ sorafenib combination therapy will be perform
Sponsors
Japan RCC Trialist Collaborative Group (JRTCG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age: 20 <= 2) Patients with confirmed clear cell renal cell carcinoma 3) Patients who have already tried nephrectomy 4) patients with no previous history of chamotherapy,cytokine therapy,or molecularly targeted drug therapy(however,patients using IFN alfa as post-nephrectomy adjuvant therapy for primary tumors will be eligible if not used for 6 or more months) 5) Patients with ECOG PS 0 or 1 6) patients with at least 1 measurable lesion on CT, as defined by RECIST 7) Patients who are expected to survive at least 12 weeks 8) Patients who meet(1)through(9) of the following test within 7 days before the start of Interferon Alfa-n1 monotherapy (1) hemoglobin >= 9.0 g/dL (2) neutrophil count >= 1,500/microL (3) (4) PT or PT-INR and APTT <= 1.5 times the maximum of the normal range at the study site (5) total bilirubin <= 1.5 times the maximum of the normal range at the study site (6) ALT and AST <= 2.5 times the maximum of the normal range at the study site ( <= 5 times the maximum of the normal range at the study site in patients with hepatic metastasis) (7) alkali phosphatase <= 4 times the maximum of the normal range at the study site (8) serum creatinine <= 2.0 times the maximum of the normal range at the study site (9) amylases and lipases <=2.0 times the maximum of the normal range at the study site 9) Patients who give written informed consent prior to the study
Exclusion criteria
Exclusion criteria: 1) Congestive cardiac failure 2) Severe arrhythmias 3) Active or symptomatic angina pectoris or coronary artery disease 4) Poorly controlled hypertension 5) History of HIV infection, or active chronic hepatitis caused by type B or type C hepatitis virus 6) Active infection 7) Intracranial metastasis 8) Convulsive disorders requiring treatment with anticonvulsants 9) History of organ transplant 10) Poorly controlled depression 11) Autoimmune hepatitis 12) History of malignant tumors 13) Radiation therapy, except for palliative therapy, within 3 weeks prior to the start of treatment 14) Significantly invasive surgery within 4 weeks prior to the start of treatment 15) Use of G-CSF within 3 weeks prior to the start of treatment 16) Pts with a history of treatment using drugs targeting VEGF or VEGF receptor 17) Pts with a history of treatment using Raf kinase, MEK, farnesyl transferase inhibitors 18) Pts being treated with adrenocortical steroids 19) Pts being treated with Minor Bupleurum Formula 20) Pts who have or have had interstitial pulmonary disease 21) Pregnant or nursing patients 22) Pts who are unable to practice appropriate contraception throughout the study period 23) Pts who abuse drugs or who have health conditions, psychological states, or social circumstances which would interfere with participation in the study or assessment of results 24) Pts with diseases or disability potentially affecting drug assessment 25) Patients who have had, or are suspected of having, allergies to sorafenib, Interferon Alfa-n1, or other interferon formulations 26) Pts with a history of hypersensitivity to biological preparations such as vaccines 27) Patients for whom oral medication may be difficult to take 28) Patients who previously encountered difficulties in treatment with IFN alfa due to adverse events caused by IFN alfa, or patients in whom IFN alfa-induced adverse events persist to this day
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response Rate (CR+PR) | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate(CR+PR+SD),Progression Free Survival,Safety | — |
Countries
Japan
Contacts
Public ContactMasatoshi Eto
Graduate School of Medical Science, Kumamoto University Department of Urology
Outcome results
None listed