RATIONALE: Gene therapy may make the body build an immune response to kill tumor cells. PURPOSE: Phase I trial to study the safety of NV1020 in patients who have colon cancer that has spread to the liver and has not responded to previous chemotherapy.
OBJECTIVES: * Determine the safety and maximum tolerated dose of a single intrahepatic NV1020 injection in patients with hepatic metastases from colon cancer that has failed first-line chemotherapy. * Determine the tolerability of this drug in these patients. * Determine preliminarily the anti-tumor activity of this drug in these patients. * Assess the immunogenicity of NV1020 in these patients. OUTLINE: This is a dose escalation study. Patients receive a single intrahepatic arterial injection of NV1020 over 10 minutes with the aid of hepatic arteriography. Cohorts of 3 patients receive escalating doses of NV1020 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 patients experience dose-limiting toxicity. Patients are followed at 1, 2, and 3 months post injection. Patients may participate in a separate long term (up to 1 year) follow-up study for continued assessment and monitoring. PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
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