Interleukin-12 Gene in Treating Patients With Liver Metastases Secondary to Colorectal Cancer

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically or cytologically confirmed\* colorectal adenocarcinoma metastatic to the liver
• •* Solitary or multiple metastatic tumors in the liver
• •* Metastatic involvement of the liver no greater than 40% of estimated liver volume NOTE: \*Must be from the hepatic tumor designated for study injection
• •Metastatic liver tumors must be bidimensionally measurable by CT scan or MRI
• •At least 1 metastatic liver tumor measuring at least 2.0 cm must be visualized by ultrasound (US) and accessible for US-guided percutaneous injection
• •Extrahepatic metastases allowed
• •No prior or current ascites
• •Ineligible for hepatic resection
• •PATIENT CHARACTERISTICS:
• •Age
• •Adult
• •Performance status
• •Karnofsky 70-100%
• •Life expectancy
• •At least 16 weeks
• •Hematopoietic
• •Granulocyte count at least 1,500/mm\^3
• •Hemoglobin at least 9.0 g/dL
• •Platelet count at least 100,000/mm\^3
• •Hepatic
• •No clinical evidence of other severe liver disease (e.g., portosystemic encephalopathy)
• •PT no greater than 14 seconds
• •Bilirubin no greater than 2.0 times upper limit of normal (ULN)
• •Transaminases no greater than 2.5 times ULN
• •Renal
• •Creatinine no greater than 1.5 mg/dL OR
• •Creatinine clearance at least 45 mL/min
• •Other
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective nonhormonal contraception during and for at least 2 months after study participation
• •HIV negative
• •No active infection
• •No other concurrent serious medical illness
• •No other malignancy within the past 5 years except inactive nonmelanoma skin cancer, carcinoma in situ of the cervix, or grade 1 papillary bladder cancer
• •Oriented and rational
• •Weight at least 30 kg
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy
• •Not specified
• •Chemotherapy
• •At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
• •Endocrine therapy
• •At least 2 months since prior corticosteroids
• •Radiotherapy
• •Not specified
• •Surgery
• •Not specified
• •Other
• •At least 2 months since prior systemic immunosuppressive drugs
• •No concurrent immunosuppressive drugs
• •No concurrent anticoagulant therapy with heparin or warfarin