Vaccine Therapy in Treating Patients With Stage III or Stage IV Kidney Cancer
Kidney Cancer
About this trial
This is an interventional treatment trial for Kidney Cancer focused on measuring stage III renal cell cancer, stage IV renal cell cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed stage III or IV renal cell carcinoma scheduled for resection of primary renal tumor No CNS metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: At least 6 months Hematopoietic: WBC at least 3,000/mm3 Hemoglobin at least 9 mg/dL (transfusion independent) Platelet count at least 100,000/mm3 No history of bleeding disorder or other blood dyscrasias Hepatic: Bilirubin less than 2.0 mg/dL PT less than 1.5 times control No serious hepatic disease Renal: Creatinine no greater than 2.5 mg/dL Calcium less than 12 mg/dL No symptomatic hypercalcemia Cardiovascular: No serious cardiac disease (e.g., New York Heart Association class III or IV heart disease) No deep vein thrombosis Pulmonary: No serious pulmonary disease (e.g., asthma or chronic obstructive pulmonary disease) No pulmonary embolism Other: No serious chronic or acute illness that would preclude study No autoimmune disease (e.g., inflammatory bowel disease, systemic lupus erythematosus, rheumatoid arthritis, ankylosing spondylitis, scleroderma, or multiple sclerosis) No psychological impediment that would preclude study No prior malignancy within past 5 years except basal cell carcinoma, carcinoma in situ of the cervix, nonmelanomatous skin cancer, controlled superficial bladder cancer, or surgically or radiologically treated prostatic adenocarcinoma with no evidence of rising PSA for at least 12 months after treatment No active acute or chronic infection (e.g., symptomatic urinary tract infection, surgical site infection, or viral hepatitis) HIV negative Must have adequate peripheral vein access Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: At least 6 weeks since prior immunotherapy (e.g., interleukin-2, interferon alfa, or autolymphocyte therapy) No other concurrent immunotherapy Chemotherapy: At least 6 weeks since prior chemotherapy and recovered No concurrent chemotherapy Endocrine therapy: At least 6 weeks since prior steroid therapy and recovered No concurrent steroid therapy Radiotherapy: At least 6 weeks since prior radiotherapy and recovered No concurrent local or palliative radiotherapy Surgery: See Disease Characteristics At least 6 weeks since other prior major surgery and recovered No prior radical nephrectomy Other: No concurrent immunosuppressive agents (e.g., azathioprine or cyclosporine)
Sites / Locations
- Duke Comprehensive Cancer Center