Interleukin-12 Gene in Treating Patients With Liver Metastases Secondary to Colorectal Cancer
Colorectal Cancer, Metastatic Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring stage IV colon cancer, stage IV rectal cancer, liver metastases, recurrent rectal cancer, recurrent colon cancer
Eligibility 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
Sites / Locations
- Icahn School of Medicine at Mount Sinai
Arms of the Study
Arm 1
Experimental
Experimental Group
Direct intratumoral injection of metastatic hepatic tumors using an adenoviral vector expressing the human recombinant interleukin-12 gene