will not undergo exploratory laparotomy following ACN53 treatment, but will instead 
undergo fine needle aspiration of the liver tumor and normal liver. 
2.0 STUDY OBJECTIVES 
2.1 To assess the safety of ACN53 when given as a single hepatic artery bolus infusion. 
2.2 To assess the biological efficacy of ACN53 against hepatocellular cancers and liver 
metastases of colorectal cancer when given as a single hepatic artery bolus infusion. 
Biological efficacy, including efficiency and stability of gene transfer , will be 
studied by analysis of tumor tissue following therapy. Clinical evidence of 
antitumor efficacy will also be noted. 
2.3 To assess the effect of dose of ACN53 given as a single hepatic artery bolus 
infusion on safety and efficacy, ACN53 will be given in escalating doses to 
successive groups of patients as tolerated. The effect of dose on patient tolerance 
and toxicity as well as on biological and clinical efficacy, will be studied. As an 
important part of this objective, the pharmacokinetics of ACN53 will be studied. 
3.0 ELIGIBILITY CRITERIA 
3 . 1 Inclusion Criteria 
Patients must fulfill all of the following criteria to be eligible for study admission: 
3.1.1 Histologic diagnosis of colorectal carcinoma or hepatocellular carcinoma. 
3.1.2 For patients with colorectal carcinoma, documented metastatic tumor or 
tumors of the liver. 
3.1.3 For patients with hepatocellular carcinoma, disease which is considered 
unresectable. 
3.1.4 Patients who have elected to undergo exploratory laparotomy with potential 
placement of a hepatic artery infusion pump for subsequent chemotherapy 
will be eligible for inclusion in this study. Patients must enroll in this study 
prior to pump placement. It is not a requirement for inclusion in this study 
that patients elect this procedure (exploratory laparotomy with potential 
placement of a hepatic artery infusion pump for subsequent chemotherapy). 
3.1.5 Evidence of p53 alteration in tumor tissue, as described in Appendix F. 
3.1.6 Age: at least 18 years of age and less than 75 years of age. 
3.1.7 Life expectancy of at least 3 months. 
3.1.8 Adequate performance status (Kamofsky score > 70%; see Appendix A). 
3.1.9 Required values for initial laboratory data (other tests are required; see 
section 5.0): WBC > 3,000/pl 
ANC > 1 ,000/jj.I 
Platelet Count > 100,000/pl 
Hct >25% (may be transfused prior to enrollment) 
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