1.0 
OBJECTIVES 
To immunize HLA-A2 positive renal cell carcinoma patients with HLA-A2 
matched allogeneic renal cell carcinoma cells that have been altered to secrete 
interleukin-2. The following will be evaluated: 
1.1 Toxicity of immunization 
1.2 Evidence for induction of humoral and cellular immunity 
1 . 3 Anti-tumor effects 
2.0 BACKGROUND 
2.1 Renal cell carcinoma . 
Renal cell carcinoma (RCC) is the fourth most common genitourinary cancer in 
the United States, with an annual incidence of 20,000 cases and death rate of 
8000 to 10,000. The natural history and clinical manifestations of RCC are 
variable (1-6). Approximately one-half of the new cases are localized to the 
kidney, and 30% of patients present with distant metastases. A radical 
nephrectomy is a curative therapy for localized RCC, with a five year survival of 
66% for patients with stage I-II disease and 35% for stage III disease (4,7,8). 
Selected patients with State IV disease, those with solitary metastases, appear to 
show a survival benefit from surgical intervention. 
Systemic therapy for metastatic RCC has limited effectiveness. Hormonal therapy 
with antiandrogens, antiestrogens, androgens, and progestins has been 
investigated, with reported response proportions of less than 2% (9,10,11). 
Chemotherapy is generally ineffective, with more than 30 drugs investigated, 
alone or in combination, and none achieving a response proportion greater than 
15-20% (10,11). Of note, spontaneous regressions are well-recognized 
occurrence in as many as 7% of patients with advanced RCC (12). This 
phenomenon has prompted the investigation of immunotherapy. The most 
promising interventions so far have been immunologic, in particular the 
cytokines. The interferons and interleukin-2 have been reported to elicit 
antitumor effects in renal cell carcinoma (13). However, the majority of trials 
have reported response proportions of less than 20% (30). 
2.2 Vaccination Studies 
[918] 
Recombinant DNA Research, Volume 15 
