This is a Phase I, open-label, dose-escalation trial in patients with advanced/metastatic solid tumors refractory to standard therapy; tumors may include malignant melanoma, non-small cell lung cancer, renal cell carcinoma, and squamous cell carcinoma of the head and neck. These tumor types were selected because evidence of biological activity was observed in these tumor types in a Phase I study of JX-594 (Pexa-Vec) administered by intratumoral injection in patients with metastatic disease to the liver. Patients will receive treatment at one of five dose levels in a sequential dose-escalating design.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
23
Intravenous Dosage from 1 x 10\^5 pfu/kg to 3 x 10\^7 pfu/kg Intravenous infusion is administered once over a 60 minute period
Billings Clinic
Billings, Montana, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Cancer Centers of the Carolinas
Greenville, South Carolina, United States
Ottawa Health Research Institute
Ottawa, Ontario, Canada
Maximally-tolerated dose (MTD) and/or maximum-feasible dose (MFD) of JX-594 administered by intravenous (IV) infusion
Time frame: 4 weeks
Safety/Toxicity: Incidence of treatment-related adverse events; treatment-related serious adverse events; treatment-related Grade 3/4 toxicities; and clinically-significant, treatment-related changes from baseline in routine laboratory parameters
Time frame: 4 weeks
Determine the JX-594 pharmacokinetics and pharmacodynamics over time following IV infusion
Time frame: 4 weeks
Determine the immune response to JX-594 following IV infusion
Time frame: 4 weeks
Determine the delivery of JX-594 to, and concentration within, solid tumors following IV infusion
Time frame: 4 weeks
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