3.1.10 
PT (or INR) 
PTT 
Creatinine 
Total Bilirubin 
AST, ALT 
Within normal range 
Within normal range 
< 1.8 mg/dl or Cr Cl > 50 cc/min 
< 1.5 mg/dl 
< 2 x upper limit of normal value 
Preserved cardio-pulmonary function: 
SaOo > 90% on room air 
FEV i > 70 % of predicted value 
3.1.11 Written informed consent has been obtained from the patient or the patient's legal 
representative. 
3 . 2 Exclusion Criteria 
Patients with any of the following will be excluded from study admission: 
3.2.1 Pregnant women. 
3.2.2 Patient is fertile, unless using effective contraception for at least 1 month. 
3.2.3 Uncontrolled serious bacterial, viral, fungal, or parasitic infection. 
3.2.4 Patients who are positive for human immunodeficiency virus (HIV) infection. 
3.2.5 Systemic corticosteroid therapy or other immunosuppressive therapy within 
the last 3 months. 
3.2.6 Prior local-regional anti-tumor therapy directed against the present liver 
tumor(s), including radiotherapy, chemotherapy, biological therapy, and 
surgery. Prior systemic anti-tumor therapy, such as intravenous cytotoxic 
chemotherapy, is not an exclusion criterion. 
3.2.7 Participation in another investigational therapy study within the last 3 months. 
3.2.8 Any underlying medical condition which in the principal investigators’ 
opinion will make the administration of ACN53 hazardous or obscure the 
interpretation of adverse events. 
4.0 REGISTRATION 
4. 1 Once a patient has met all enrollment requirements and is eligible for the study, the 
patient will be registered by telephone with the University of California, San 
Francisco (UCSF) Clinical Research Office at (415) 476-3741, prior to the 
initiation of treatment. At the time of registration, all pre-study requirements will be 
confirmed and the following information will be collected: name of referring 
physician's name, protocol number, name of patient, medical record number, social 
security number, sex, race, birthdate, address, and date of patient signing of the 
informed consent form. 
4.2 All patient registrations will be entered with Canji, Inc. by telephone at 
(619) 597-0177 or by facsimile transmission at (619) 597-0237. 
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