STUDY PROCEDURE 
If I agree to participate in this study, I have been informed that the following events will occur: 
Before the Study 
I will be evaluated by the doctors for my eligibility for the study and to adequately assess my 
condiuon. I will have a complete physical examinadon, blood tests (about 2 tablespoons of 
blood), urine tests, a chest x-ray, pulmonary (lung) funcdon tests, an electrocardiogram (an 
electrical recording of my heart), and a computed tomography (CT) or magnedc resonance 
imaging (MRI) scan of my abdomen and pelvis. In addidon, samples of my tumor will be 
tested in the laboratory for evidence of genedc alteradon of the p53 gene, which is required to 
determine my eligibility. Some tests may need to be repeated. 
I may decide to undergo an operadon to receive a hepadc artery infusion pump, a device 
requiring an operadon for placement which can later be used to administer chemotherapy 
into the liver. Whether or not I decide to undergo the operadon depends on whether I and 
my doctors decide that it is an appropriate form of treatment for me, and is unrelated to 
whether I participate in this study or not. In other words, I may decide: 1) to receive the 
operadon and not participate in the study; 2) to not receive the operadon and participate in 
the study; 3) to do both; or 4) to do neither. 
If all of my tests meet the eligibility requirements, I will then begin treatment. 
Treatment Procedure 
I will be admitted to the General Clinical Research Center (GCRC) at Moffitt-Long 
Hospital of UCSF Medical Center. I will have a hepadc angiogram, which involves 
inserting a catheter (thin tube) into an artery in my groin and then guiding the catheter to the 
hepadc (liver) artery using X-ray pictures. Dye will be put into the catheter to allow the 
doctors to take additional X-ray pictures of the arteries in my liver. If my doctors and I 
have decided that I will undergo an operadon to receive a hepadc artery infusion pump, this 
angiogram, which is necessary to evaluate me for the operadon, will also be used for this 
study. Another procedure called hepadc vein sampling will be performed after the 
angiogram. In this procedure, another catheter will be inserted into a vein in my arm and 
then guided to the hepadc vein by X-ray. This catheter will be used to collect samples of 
blood (1 tablespoon at a time) for tests. Blood will also be taken from another vein in one 
of my arms for tests. I will then receive the study drug, ACN53, which will be 
administered to my liver using the hepadc artery catheter. This is a one-time treatment, and 
I will receive no additional doses of the drug. The dose of ACN53 that I will receive will 
depend upon what happens to any previous patients who receive ACN53. In other words, 
the very first patients to receive ACN53 will be given a low dose to help ensure safety. If 
the low dose appears to be safe, the next group of patients will receive a somewhat higher 
dose. If this dose appears to be safe, the next group of patients will receive a still higher 
dose, and so on. If any significant side-effects are observed, the dose for subsequent 
patients will either remain the same or be reduced to a level which previously appeared to 
be safe. After the single treatment, the hepatic artery catheter will be removed, and pressure 
will be applied to my groin to prevent bleeding. 
After the Treatment 
After the treatment, I will be monitored very closely for any side -effects or other problems. 
I will remain hospitalized for at least 72 hours after I receive the drug to ensure that I am 
observed closely. The hepatic vein catheter will stay in place for 6 hours after I receive the 
drug, and blood will be collected periodically from it as well as from another vein in one of 
my arms for tests. In addition to blood tests, urine and stool will be collected for tests to 
determine if my body is excreting the drug as opposed to breaking it down. It is expected 
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Recombinant DNA Research, Volume 20 
