conditions (DNA -20^C, DMRIE/DOPE 4°C). The materials will be supplied by Vical 
Inc. 
5.1 VCL 1005 (HLA-B7 Plasmid DNA) /DMRIE/DOPE: 
This study drug is composed of plasmid DNA coding for the complete human MHC 
HLA-B7 formulated with the cationic lipid mixture DMRIE/DOPE (lipid complex 
formulation). The DNA concentration is 1.0 mg/ml (see Investigator's brochure for 
complete details of product characteristics and preparation). 
5.2 Lactated Ringer's : 
Ready available at the site. 
6.0 STUDY DRUG ADMINISTRATION AND TOXICITIES TO BE 
MONITORED 
DNA/lipid complexes are prepared immediately prior to admmistration. DNA is 
supplies in 1.0 mg/ml concentration in 400 pi lactated Ringer's solution. Lipid 
(DMRIE/IX)PE) is supplies as a dried film. Each vial contains 77 pg DMRIE and 90 pg 
DOPE. Each vial is reconstituted with 400 pi lactated Ringer's solutions by vortexing 
until homogeneous. The contents of the lipid vial is transferred into the DNA vial and 
mixed well by repeated inversion. The final concentration of the HLA-B7 plasmid 
DNA is 500 pg/ ml. The amount injected into each tumor will be 0.5 ml, for the highest 
dose of 250 pg. Lower doses, 10 and 50 pg, will be prepared in a similar fashion or 
formulated as dilutions with lactated Ringer’s. 
Tumor lesions will be selected for treatment if they are accessible to intratumor 
administration by direct needle injection. These metastatic lesions will be located at 
any accessible site such as skin, nodes, lung, liver, spleen. If necessary, the study drug 
will be injected with the aid of sonographic or CAT scan visualization of the metastasis. 
Prior to injection following placement of the needle, gentle aspiration will be applied to 
the syringe to ensure that no material is injected intravenously. Vital signs will be 
measured every 15 minutes prior to, during, and after the injection for at least two 
hours or until the patient is stable. If the systolic blood pressure drops below 80 mm 
Hg, the injection will be terminated immediately and the patient will be closely 
morutored or treated appropriately until blood pressure is normalized. 
Within 1 hour cifter the injection, a blood sample will be obtained to check serum 
enzymes, blood chemistries and cell counts, and to ancJyze by PCR for the presence of 
ITLA-B7 plasmid DNA in the peripheral blood. Every patient will be checked at 48 
hours and another blood collection will be drawn as described in Section 7 below. If 
any abnormalities appear, the patient will be closely observed. All toxicities will be 
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