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Brief Title: Safety Study of Recombinant Vaccinia Virus to Treat Refractory Solid Tumors
Official Title: 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
Study ID: NCT00625456
Brief 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
Name: David Kirn, MD
Affiliation: Jennerex Inc.
Role: STUDY_DIRECTOR