3 out of 3 
The MTD has been reached at the previous 
(lower) level and dose escalation will stop. 
6.4 Schema 
6.4.1 Patients will be admitted to the General Clinical Research Center (GCRC) at 
Moffitt-Long Hospital of UCSF Medical Center on the day of treatment (Day 1). 
6.4.2 Hepatic angiography will be performed via hepatic artery catheter, placed 
percutaneously and with fluoroscopic guidance, in the Interventional Radiology 
Suite at Moffitt-Long Hospital of UCSF Medical Center. 
6.4.3 Following angiography, ACN53 will be infused via the hepatic artery catheter. 
6.4.4 After administration of ACN53, the hepatic artery catheter will be removed. 
Patients will be closely observed and hemostasis applied to the arterial 
puncture site. Selective percutaneous hepatic vein catheterization will be 
performed percutaneously prior to ACN53 administration, and serum 
samples obtained from the hepatic vein for pharmacokinetic analysis. 
6.4.5 After adequate hemostasis is achieved, patients will return to the GCRC for 
further observation and study evaluations. Patients will remain in the GCRC 
for at least 72 hours (Days 1-3). 
6.4.6 Patients who have elected to undergo exploratory laparotomy with potential 
placement of a hepatic artery infusion pump for subsequent chemotherapy 
will proceed to laparotomy after an observation period of at least 7 days 
following ACN53 treatment, and only if and when they are deemed 
surgically fit (see Section 8.4, Criteria for Post-Treatment Laparotomy). 
7.0 STUDY EVALUATIONS 
7 . 1 Immediate Post-Treatment Monitoring 
7.1.1 Vital signs 
Vital signs (body temperature, respiratory rate, heart rate, blood pressure) 
will be performed immediately prior to infusion, every 15 minutes during 
Hour 1, and then at Hours 2, 4, 8, 12, 16, 20, and 24 post-infusion. Vital 
signs will then be performed every 8 hours until patient discharge from the 
General Clinical Research Center. 
7.1.2 Shedding and excretion of ACN53 
Urine and stool will be collected from patients on Days 1-3, and will be 
assayed for ACN53 by a rapid on-site ELISA assay (Appendix G). If 
ACN53 is detected on Day 3, urine and stood collection and ACN53 assay 
will continue daily until ACN53 is no longer detected in urine and stool. 
Patients will not be discharged from the GCRC until this time. It is likely 
that systemic levels of ACN53 given by hepatic artery infusion will be 
extremely low because of hepatic extraction and clearance (the 
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