advanced renal cell cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1)PS 0,1 or 2. (2)MSKCC risk classification; favorable or intermediate. (3)Histological confirmed renal cell carcinoma. Not includes sarcomatoid RCC as a major component. (4)Patients with pulmonary metastasis only, but includes those with no appearance of new lesion 4 weeks after surgical resection of extra-pulmonary metastasis. (5)No ischemic heart disease (6)Laboratory evaluation 1)Respiratory function; %VC >=80%, FEV1.0 >=70% 2)WBC>=4,000/mm2, platelet>=10,000/mm2 3)AST, ALT within normal range of each institute. total bil.<1.5mg/dl serum creatinine<2.0mg/dl, BUN<25mg/dl
Exclusion criteria
Exclusion criteria: (1)uncontrolled DM (2)ischemic heart disease (3)allergic reaction to IL-2 and/or IFN-alpha (4)auto-immune disease (5)patients having Shou-Sai-Kotou (special herbal drug) and/or steroids (6)depression (7)Investigator determines as unsuitable
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| anti-tumor response | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to progression, duration of response, overall survival, servival at home, performance status | — |
Countries
Japan
Contacts
Yamagata University Hospital Department of Urology