Phase II Study of a B7-1 Gene-Modified Autologous Tumor Cell Vaccine and Systemic IL-2

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed stage IV renal cell carcinoma
• •* Symptomatic primary tumor or resectable metastasis
• •Measurable disease post resection
• •No symptomatic brain metastases
• •PATIENT CHARACTERISTICS:
• •Age:
• •18 and over
• •Performance status:
• •Eastern Cooperative Oncology Group (ECOG) 0-1
• •Life expectancy:
• •Not specified
• •Hematopoietic:
• •WBC greater than 4,000/mm\^3
• •Platelet count greater than 100,000/mm\^3
• •Hemoglobin greater than 10 g/dL
• •Hematocrit greater than 30%
• •Hepatic:
• •Bilirubin less than 2 times normal
• •SGOT less than 3 times normal
• •Renal:
• •Creatinine less than 1.5 mg/dL OR
• •Creatinine clearance greater than 60 mL/min
• •Cardiovascular:
• •No evidence of active myocardial ischemia, prior myocardial infarction, or arrhythmia
• •Other:
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception
• •No contraindications to surgical resection
• •No history of immunodeficiency disease
• •No known allergy to penicillin
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy:
• •Prior interleukin-2, interferon alfa, or other biologic agent allowed
• •Chemotherapy:
• •Not specified
• •Endocrine therapy:
• •No concurrent corticosteroids (except for replacement doses for adrenal insufficiency)
• •Radiotherapy:
• •Not specified
• •Surgery:
• •See Disease Characteristics
• •Other:
• •No concurrent immunosuppressants