Study design
tumor, fever
LIVER METASTASIS, TUMOR
The study was a phase 1 clinical trial offered at Mayo Clinic in Rochester, MN. The primary objective was to determine the safety profile of VSV-IFNβ-TYRP1 administered via IV and IT routes. Secondary objectives were to gather preliminary data on tumor response and progression-free survival (PFS). We investigated both viral and immunological correlates.Treatment was administered on Day 1 of Cycle 1. VSV-IFNβ-TYRP1 was injected into an accessible liver metastasis under image guidance (typically ultrasound). IV VSV-IFNβ-TYRP1 was given with 100ml of normal saline with 1% human serum albumin (HSA) over 30 minutes. To maximize patient safety, treatment was administered in an inpatient clinical research unit with close monitoring for 24-48 hours. Patients received acetaminophen 650 mg one hour prior to infusion, then every 6 hours for 24 hours to mitigate fever.A 3 + 3 Phase I clinical trial design was carried out. The IT dose delivered was 3x10