NCT01169584

Safety Study of Recombinant Vaccinia Virus to Treat Refractory Solid Tumors in Pediatric Patients

A Phase I, Open-Label, Dose Escalation Study of JX-594 (Vaccinia GM-CSF/Thymidine Kinase-Deactivated Virus) Administered by Intratumoral Injection in Pediatric Patients With Unresectable Refractory Solid Tumors.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Jennerex Biotherapeutics · Industry
• Sex: All
• Age: 2 Years – 21 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase I, open-label, dose-escalation trial of JX-594 (Pexa-Vec) in pediatric patients with advanced/metastatic, unresectable solid tumors refractory to standard therapy and/or the patient does not tolerate standard therapies. Tumors are likely to include neuroblastoma, lymphoma, Wilms' tumor, rhabdomyosarcoma, Ewing's sarcoma, osteosarcoma, non-rhabdomyosarcoma soft tissue sarcomas, and malignant peripheral nerve sheath tumors. Benign tumors are excluded. These tumor types were selected because evidence of biological activity was observed in cancer cells lines and ex vivo infected primary human tissue samples, specifically pediatric cancer types such as sarcomas and neuroblastomas.

Conditions

• Neuroblastoma
• Rhabdomyosarcoma
• Lymphoma
• Wilm's Tumor
• Ewing's Sarcoma

Interventions

Type	Name	Description
DRUG	Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)	Intratumoral Injection Dosage from 1 x 10\^6 pfu/kg to 3 x 10\^7 pfu/kg is administered once to 1-3 injectable tumors in pediatric patients.

Timeline

• Start date: 2010-08-01
• Primary completion: 2012-03-01
• Completion: 2014-11-01
• First posted: 2010-07-26
• Last updated: 2016-01-21

Locations

2 sites across 1 country: United States