Gene Therapy in Treating Patients With Colon Cancer That Has Spread to the Liver
Colorectal Cancer, Metastatic Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring stage IV colon cancer, recurrent colon cancer, adenocarcinoma of the colon, liver metastases
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the colon At least 3 metastatic hepatic lesions involving both lobes No extrahepatic disease Failed first-line combination chemotherapy of fluorouracil plus either leucovorin calcium or irinotecan Herpes simplex virus type-1 seropositive Candidate for intrahepatic arterial infusion pump placement PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: WBC greater than 3,000/mm^3 Absolute neutrophil count greater than 1,500/mm^3 Platelet count greater than 100,000/mm^3 Hemoglobin greater than 9.0 g/dL No history of any blood clotting disorder (e.g., hemophilia) Hepatic: Transaminases no greater than 3 times upper limit of normal Bilirubin no greater than 2.0 mg/dL No active hepatitis No history of hepatic fibrosis, cirrhosis, or hemochromatosis Renal: Creatinine no greater than 2.0 mg/dL Other: Not pregnant or nursing Negative pregnancy test All patients must use effective barrier contraception during and for at least 6 months after study HIV negative No active herpes infection No other active uncontrolled infection No prior weight loss of more than 10 lbs within the past month No history of alcohol or other substance abuse No concurrent unstable and/or severe medical or psychological condition No history of any other medical or psychological condition that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy (e.g., interleukin-2, interleukin -12, or interferon) No prior gene transfer therapy No prior therapy with cytolytic virus of any type No concurrent immunotherapy during and for 28 days after study therapy No concurrent vaccines during and for 28 days after study therapy Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) No concurrent chemotherapy during and for 28 days after study therapy Endocrine therapy: No concurrent systemic steroids during and for 28 days after study therapy Radiotherapy: No prior radiotherapy to the liver No concurrent radiotherapy during and for 28 days after study therapy Surgery: At least 2 weeks since prior surgery Other: At least 30 days since prior participation in investigational study No concurrent antiviral agent active against herpes simplex virus (e.g., acyclovir, valacyclovir, penciclovir, famciclovir, ganciclovir, foscarnet, or cidofovir) during and for 28 days after study therapy No concurrent immunosuppressive agents (e.g., cyclosporine) during and for 28 days after study therapy No other concurrent investigational or anti-cancer agents during and for 28 days after study therapy
Sites / Locations
- Memorial Sloan-Kettering Cancer Center