NCT00625456

Safety Study of Recombinant Vaccinia Virus to Treat Refractory Solid Tumors

A Phase I Dose Escalation Study of JX-594 (Thymidine Kinase-deleted Vaccinia Virus Plus GM-CSF) Administered by Intravenous Infusion in Patients With Refractory Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Jennerex Biotherapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Melanoma
• Lung Cancer
• Renal Cell Carcinoma
• Squamous Cell Carcinoma of the Head and Neck

Interventions

Type	Name	Description
DRUG	Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)	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

Timeline

• Start date: 2008-06-01
• Primary completion: 2010-04-01
• Completion: 2014-06-01
• First posted: 2008-02-28
• Last updated: 2015-12-03

Locations

4 sites across 2 countries: United States, Canada