Interferon-Beta Gene Transfer (Ad.hIFN-β) as Treatment for Refractory Colorectal Carcinoma With Liver Metastases

Inclusion Criteria: * Subjects with histologically confirmed hepatic metastases from primary colorectal carcinoma. * Not amenable to complete surgical resection for attempted cure as determined by the Principal Investigator (PI). * Tumor progression after prior therapy for colorectal carcinoma, including fluoropyrimidine (5 FU or capecitabine), irinotecan, oxaliplatin, or cetuximab. * One or more metastatic hepatic tumors that is measurable on CT scan. In addition, subjects may have nonhepatic metastatic tumors. * ECOG performance status of ≤ 1. * Age ≥ 18 years. * Signed, written IRB-approved informed consent. * Men and women of reproductive potential must be willing to follow accepted birth control methods during treatment and for 3 months after completion of treatment. * Acceptable liver function: * Bilirubin ≤ 1.5 x upper limit of normal; * AST, ALT ≤ 2.0 x upper limit of normal; * Albumin ≤ 3.0 g/dL. * Acceptable hematologic status: * Granulocyte ≥ 1000 cells/mm3; * Platelet count ≥ 150,000 plts/mm3; * Hemoglobin \> 9 g/dL. * Acceptable coagulation status: INR within normal limits. * Acceptable kidney function: Serum creatinine within normal limits. Exclusion Criteria: * New York Heart Association Class III or IV cardiac disease, myocardial infarction within the past 6 months prior to Day 1, unstable arrhythmia, or evidence of ischemia on ECG within 14 days prior to Day 1. * Seizure disorders requiring anticonvulsant therapy. * Severe chronic obstructive pulmonary disease with hypoxemia. * Major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1. * Active uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy. * Pregnant or nursing women. * Treatment with radiation therapy, surgery, chemotherapy, or investigational therapy within 1 month prior to study entry. * Unwillingness or inability to comply with procedures required in this protocol. * Known infection with HIV, hepatitis B, or hepatitis C. * Serious nonmalignant disease (e.g., hydronephrosis, liver failure, or other conditions) that could compromise protocol objectives in the opinion of the investigator and/or the sponsor. * Clinically significant bleeding event within the last 3 months, unrelated to trauma. * More than 50% of liver replaced by tumor (estimated by the PI from CT scan within 14 days of Day 1). * Previous treatment with Ad.hIFN-β. * Any prior treatment with a gene delivery vector or an adenovirus therapeutic agent.