A Phase I, Open-Label, Dose-Escalating Study Of The Safety, Tolerability, And Anti-Tumor Activity Of A Single Intrahepatic Arterial Injection Of Genetically Engineered Herpes Simplex Virus, NV1020, In Subjects With Adenocarcinoma Of The Colon With Metastasis To The Liver
- Determine the safety and maximum tolerated dose of a single intrahepatic NV1020
injection in patients with hepatic metastases from colon cancer that has failed
- 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.
Primary Purpose: Treatment
Yuman Fong, MD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|