drugset / Trial / NCT00625456
Safety Study of Recombinant Vaccinia Virus to Treat Refractory Solid Tumors
Non-randomizedSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2008-06
- Primary completion
- 2010-04
- Completion
- 2014-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pexastimogene Devacirepvec | Other / unclassified | — | Intravenous |