are well-tolerated. Doses will be repeated within each subject 
for whom the toxicity treatment is with < grade II. Dose 
escalation will begin if three patients show toxicities < grade 
III from the treatment. If one patient displays toxicity > grade 
II, the treatment will be repeated on three additional patients. 
If two patients develop toxicity > grade II, the dosage will be 
reduced. The maximal tolerated dose will be defined as the dose 
at which two or more patients out of six develop grade III or IV 
toxicity. The treatment dose will be established at one level 
below the maximum tolerated dose. Once the treatment dose is 
defined, an additional four to six patients will be entered at 
that dose to ascertain the safety of this dose for wider 
application. 
Prior to the injection with the needle in place, gentle 
aspiration will be applied to the syringe to ensure that no 
material is injected intravenously. Immediately after the 
injection procedure, a blood sample will be obtained to check 
serum enzymes, chemistries, and blood counts, and to analyze for 
the presence of plasmid DNA in the peripheral blood by PCR. The 
patients will be observed in the Clinical Research Center for an 
additional 48 hours, and another blood collection performed as 
described r in Section 9. If there are no complications, the 
patient will be discharged after 48 hours. Should any 
abnormalities appear, the patient would be kept for further 
observation. 
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Recombinant DNA Research, Volume 17 
