Fifty percent increase in the size of indicator lesion(s) 
compared to the smallest measurements while on study. 
11.6.2.2 Patients with measurable indicator lesion(s) who 
have met the criteria for complete response. 
Progression will be declared for reappearance of any tumor. 
11.6.2.3 Any new lesions. 
11.6.3 Significant clinical deterioration that cannot be 
attributed to treatment or other medical conditions. 
11.6.3.1 Weight loss >5% body weight. 
11.6.3.2 Worsening of tumor-related symptoms. 
11.6.3.3 ECCX3 Performance status decline >1 level 
11.7 Criteria for stable (SD) 
Failure to meet the criteria for complete response, partial response, 
regression, or progression. 
12.0 Descriptive Factors 
None 
13.0 Treatment/Follow-up Decision at Evaluation of Patient 
Patients meeting the criteria for partial response 4 weeks after their single Schedule 
A injection or after their last Schedule B injection on may be retreated once. 
14.0 Pharmacologic /Immunologic Studies 
14.1 Immunochemical staining will be done iat a central laboratory facility as 
specified by VICAL, Inc. Pre-and post-treatment tumor cells are stained 
with anti-HLA-B7 antibodies, ME-1, BB7.1, and GSP5.3 (G. Nabel, 
personal communication) to look for expression. 
14.2 Presence of DNA from the HLA-B7 gene will be assessed by PCR 
amplification of cells obtained by biopsy of the treated site on days 8, 15, 
and 29 after injection of DNA/lipid complex. Genomic DNA is isolated 
by standard methods and a portion of the HLA-B7 gene is amplified and 
sequenced. Several primer sequences may be used (G. Nabel, personal 
communication). These studies will be carried out in a central laboratory . 
14.3 Development of circulating antibodies to HLA-B7 will be evaluated. 
Autologous peripheral blood B lymphocytes will be EBV immortalized and 
subjected to in vitro gene transfer with the DNA/lipid complex, these 
autologous cells expressing the HLA-B7 gene will be used to assess the 
specificity of antibody response to the in vivo transfer of the gene. Evidence of 
cytolytic T-cells will be assessed if a sufficient amount of material is available 
for successful expansion of infiltrating T-cell population from cells in biopsy 
of the metastasis. These studies will be carried out in a central laboratory. 
15.0 Statistical Consideration and Methodology 
Descriptive statistics only will be performed due to the small number of patients. 
16.0 Pathology Considerations 
16.1 Patients entering this trial will already have had histologically-documented 
metastatic renal cell carcinoma. A biopsy is carried out as part of this 
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