3.0 Patient Eligibility 
3.1 Inclusion criteria 
Prior to discussing protocol entry with the patient, call the Research nurse 
(Diana Karius, R.N., M.S.N., 702-2085 or pager 6732) to insure that a place on 
the protocol is open to the patient. 
3.1.1 Histologically-confirmed metastatic renal cell carcinoma. 
3.1.2 At least two metastatic lesions or one rrietastatic lesion and an intact 
primary that are clearly measurable in two dimensions on CT scan. At 
least one metastasis must measure between 2.0 and 4.0 cm m greatest 
diameter and be accessible for intralesional injection. 
3.1.3 Patients must have had prior standard therapy for their disease and 
have become unresponsive to it or have made the decision that other 
therapy would not be of any benefit. 
3.1.4 Must be 18 years old. 
3.1.5 The following laboratory values within 15 days of registration: 
white blood count >3,000. 
platelet count >100,000. 
Hemoglobin >9g/ dl. 
prothrombin time < 1.5 x control. 
serum creatinine < 2.0 mg/dL. 
total bilirubin <1.5 unless due to Gilbert’s disease. 
SCOT, SGPT < 3x the upper limit of normal unless due to disease 
3.1.6 Karnofsky Performance Scale (KPS) score > 70. 
3.1.7 Estimated life expectancy of at least 12 weeks. 
3.1.8 HLA typing must indicate that the patient is HLA-B7 negative. 
3.1.9 Must be anti-HIV antibody negative. 
3.1.10 Women/men of reproductive potential agree to use effective 
contraception. 
3.1.11 Patients must be immunocompetent by antigen skin test. 
3.2 Exclusion criteria 
3.2.1 Positive antibody to HIV. 
3.2.2 Active autoimmune disease. 
3.2.3 Hepatitis (acute or chronic active). 
3.2.4 Active infection. 
3.2.5 No radiation, biologic therapy or chemotherapy with 4 weeks ( 6 
weeks for mitomycin of nitrosourea). 
3.2.6 No corticosteroids within 2 weeks. 
3.2.7 Diabetes mellitus not controlled by medical treatment. 
3.2.8 Psychiatric illness that may make compliance to the clinical protocol 
unmanageable or may compromise the patient's ability to give informed 
consent. 
4.0 Test Schedule 
[214] 
Recombinant DNA Research, Volume 19 
