that my body, and especially my liver, will break down the drug rapidly. However, I will 
remain hospitalized until it is determined that my body is not excreting the drug. After I am 
discharged I will need to come to the Ambulatory Care Center of UCSF Medical Center as 
an outpatient weekly for one month, then every two months for the first year and then 
yearly to conunue the monitoring and testing associated with the study. I must report any 
health-related problems, whether or not I think they are related to the treatment, to my 
doctors. On each visit I will receive additional physical examinations and blood tests (1 to 2 
tablespoons at a time). Additional tests may be necessary to evaluate any problems that may 
arise. 
If my doctors and I have decided that I will undergo an operation to receive a hepatic artery 
infusion pump, I will be able to undergo the operation at least a week after the study 
treatment, and only when it is the clinical judgment of the doctors, including the surgeon, 
that I am fit and ready for it. By participating in this study, I will probably undergo the 
operation to receive the pump at a slightly later date than had I not participated in the study. 
Moreover, once the pump is placed, chemotherapy using the pump will be delayed by 
about two weeks in order to perform the tests required in the study. During the operation, 
the pump will be placed first, and then I will have biopsies (samples of less than a thimble- 
full in size) of my tumor and of the normal-appearing portion of my liver as part of the 
study, to measure the efficiency and effects of the gene therapy on these tissues. 
% 0 
If my doctors and I have decided that I will not undergo an operation to receive a hepatic 
artery infusion pump, I will receive a biopsies (samples of much less than a thimble-full in 
size) of my tumor and liver using a fme (very thin) needle inserted through my abdomen 
and directly into my liver. Either an ultrasound or CT scan will be used to guide the 
placement of the needle. 
After the operation or needle biopsy, I will need to continue coming for follow-up visits to 
the Ambulatory Care Center of UCSF Medical Center as described above. I will have a 
repeat scan (CT or MRI) of my liver one month after the study treatment to evaluate any 
changes associated with the treatment. 
SPECIAL CONSIDERATIONS 
Duration of Study Participation 
Because gene therapy is a very new form of therapy, and the long-term effects and outcome 
are not yet known, I understand the need for careful follow-up. The period of my most 
active participation in this study will last approximately 1 month from the time of the 
treatment. After this, I will be monitored every two months for the first year. After this, I 
will contact the doctors involved with the study on a yearly basis for my lifetime. I will 
notify the doctors if I change my address. 
Tentative Agreement for Autopsy 
In case of my death from any cause during or after my participation in this study, I 
understand that an autopsy may provide additional information about the treatment I 
received. My participation in the study means that I would tend to favor an autopsy in the 
event of my death. I will notify my family of my opinion, but I understand that this 
tentative agreement is non-binding. 
Recombinant DNA Research, Volume 20 
