2.3 To measure humoral and cellular immune responses to HLA-B7. 
2.4 To confirm expression in vivo of the HLA-B7 gene in the tumor cells. 
2.5 To characterize the clinical response to escalating doses of the study drug 
by assessing the size of the injected tumor and of other tumor masses that 
may be present. 
3.0 Patient Eligibility 
3.1 Required characteristics -- Prior to discussing protocol entry with the 
patient, call the Randomization Center to insure that a place on the 
protocol is open to the patient. 
3.1.1 Must have histologically-confirmed metastases from primary 
adenocarcinoma taking origin in the colon or rectum. 
3.1.2 Must have at least two liver metastases that are clearly measurable 
in two dimensions on CT scan, one of which must measure 
between 2.0 and 4.0 cm in greatest diameter and would be 
accessible for intralesional injection. 
3.1.3 Must have had either prior standard therapies for their disease and 
have become unresponsive to them or have made the decision that 
other therapy would not be of any benefit. 
3.1.4 Must be 2 18 years old. 
3.1.5 The following laboratory values (<15 days of registration): 
• white blood count >3,000. 
• platelet count >100,000. 
• Hemoglobin >9 g/ dl. 
• prothrombin time >1 second greater than control. 
• serum creatinine >125% of upper limit of normal. 
• direct serum bilirubin above the upper limit of normal or 
• SGOT or alkaline phosphate >3x above the upper limit of 
normal. 
3.1.6 Must have a baseline Karnofsky Performance Scale (KPS) score of 
at least 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. 
3.1.9a Must be HBsAg and anti-HIV antibody negative since positivity for 
either disease may be associated with reduced immune 
competence. 
3.1.9b Women/men of reproductive potential agree to use effective 
contraception. 
3.1.10 Patients must be immunocompetent by having at least 2/7 positive 
skin tests on the Merieux Multitest and by having a PHA 
lymphocyte response in the normal range. 
3.2 Contraindications 
3.2.1 Positive antibody to HIV or HBsAg. 
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Recombinant DNA Research, Volume 18 
