Experimental endpoints
ADENOVIRUS
We evaluated the persistence of the adenoviral DNA in patient’s blood as a measure of the viral replication. Presence of Ad5-IL-12 adenoviral DNA detected in patient blood 7–10 days after adenoviral administration suggests potential viral replication (at the site of injection). The viral load was measured by PCR for a target sequence that is common for all our adenoviral vector constructs. We evaluated Ad5-IL-12 adenoviral DNA in all the patients as described in methods. Genomic DNA extracted from the blood donated by a healthy volunteer and spiked with the adenovirus was used as a positive control for the PCR. Viral DNA was not detected in cohorts where patients were injected with low viral dose (cohorts 1–3, 1x10