Issues relating to the potential risks associated with proviral 
insertion itself are more difficult to evaluate, since no i_n vitro assays have 
been able to detect such events. In contrast to previous clinical protocols 
involving live, transduced tumor cells, however, the protocol described here 
is different in that the use of irradiated cells as vaccines preclude the 
possibility that the growth properties of the vaccine cells might be altered 
by the gene transfer process. We believe that the use of irradiated cells is, 
therefore, extremely important from patient safety standpoint. 
4.0 PATIENT ELIGIBILITY 
4.1 Prior to final enrollment in the study, patients must have a 
documented diagnosis of Stage III T4b or Stage IV RCC after surgery. There 
must be unambiguous histologic confirmation that the primary tumor is renal 
cell carcinoma. If a diagnosis of RCC has already been established by needle 
biopsy, it must be reconfirmed histologically at nephrectomy. 
4.2 Patients must not be pregnant and must be greater than 18 years of 
age. There must be no second form of cancer present at enrollment. 
4.3 Patients must have a performance status (Eastern Cooperative 
Oncology Group of 0 or 1 and must have an estimated life expectancy of 6 
months or more. 
4.4 Patients must sign standard informed consent for surgery and 
general anesthesia at the Johns Hopkins Hospital. In addition, patients must 
give written informed consent to participate in this trial (Section 12) prior 
to surgery. 
4.5 Patients must have had no other recent major surgery, i.e., be at 
least 1 month post any surgical procedure. In addition, no immunosuppressive 
therapy including topical or oral corticosteroids, radiotherapy, or cytotoxic 
therapy can have been administered within 1 month prior to enrollment. 
Patients must be at least one month post any form of immunotherapy (for 
example, IL-2, interferon-alpha, ALT therapy) prior to enrollment. 
4.6 Patients must have adequate bone marrow function (WBC > 4000/uL, 
platelets > 100,000/uL), hepatic function (total bilirubin < 1.5 mg/d:) and at 
day -7 to Stage 2 of the trial must have adequate uninephric renal function 
(creatinine < 2.0 mg/dL) . Patients must be seronegative for HIV, also. 
Patients must have no documented history of the following auto-immune 
diseases: systemic lupus erythematosus, sarcoidosis, rheumatoid arthritis, 
autoimmune hemolytic anemia, auto-immune thyroiditis, glomerulonephritis, or 
vasculitis . 
4.7 Patients must be negative for brain metastases by enhanced cranial 
CT or MR I prior to final enrollment. 
4.8 No active infections requiring treatment may be present, including 
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