Vaccine Therapy With or Without Fludarabine in Treating Patients With Stage IV Kidney Cancer
Kidney Cancer
About this trial
This is an interventional treatment trial for Kidney Cancer focused on measuring recurrent renal cell cancer, stage IV renal cell cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed renal cell carcinoma Stage IV disease Received no benefit from standard therapy OR ineligible for standard therapy OR declined standard therapy At least 1 site of metastatic disease that can be surgically removed AND at least 1 site of metastatic disease than can remain in the patient (indicator lesion) after surgery Total volume of the site or sites of disease to be surgically removed must be > 2.0 cm^3 Unidimensionally measurable disease At least 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan No brain metastasis PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy More than 6 months Hematopoietic WBC ≥ 3,000/mm^3 Platelet count ≥ 75,000/mm^3 Hemoglobin ≥ 10 g/dL Hepatic SGPT and SGOT ≤ 2.5 times upper limit of normal (ULN) Bilirubin ≤ 1.5 times ULN Hepatitis C antibody negative Hepatitis B surface antigen negative Renal Creatinine ≤ 1.5 times ULN Creatinine clearance > 40 mL/min Cardiovascular No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Immunologic Coomb's test negative HIV-1 and -2 negative No active infection No unexplained fever (temperature > 100.5° F or 38.1°C) No lymphocytopenia No hypogammaglobulinemia No autoimmune disease or other immunocompromising condition that would preclude study participation No history of impaired immune response No history of tuberculosis OR positive PPD skin test No history of allergic reaction attributed to compounds of similar biological composition to study vaccine No history of allergic reaction to antibiotics Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 1 month after study participation No psychiatric illness or social situation that would preclude study participation No other malignancy within the past 5 years except resected basal cell carcinoma or carcinoma in situ of the cervix No other concurrent illness PRIOR CONCURRENT THERAPY: Biologic therapy More than 4 weeks since prior immunotherapy Chemotherapy More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) Endocrine therapy At least 4 weeks since prior steroid therapy or steroid-containing compounds At least 2 weeks since prior topical or inhaled steroids Radiotherapy More than 4 weeks since prior radiotherapy Surgery See Disease Characteristics Other More than 4 weeks since prior investigational agents More than 1 week since prior antibiotics No concurrent renal dialysis No concurrent anticoagulants No other concurrent anticancer agents or therapies No other concurrent investigational agents
Sites / Locations
- Midwest Heart Surgery Institute, Limited
- Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center