NCT01584284

Safety Study of Attenuated Vaccinia Virus (GL-ONC1)With Combination Therapy in Head & Neck Cancer

Phase I Trial Of Attenuated Vaccinia Virus (GL-ONC1) Delivered Intravenously With Concurrent Cisplatin and Radiotherapy in Patients With Locoregionally Advanced Head and Neck Carcinoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Genelux Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety and tolerability of GL-ONC1 administered intravenously in combination with radiation therapy and cisplatin (CDDP)in patients with locoregionally advanced head and neck cancer.

Detailed description

GL-ONC1, an oncolytic vaccinia virus, has shown the ability to preferentially locate, colonize and destroy tumor cells in more than 40 different human tumors. A First-in-Man, Phase I clinical study focusing on the safety and tolerability of GL-ONC1 intravenously administered to patients with a variety of advanced solid tumor entities has shown that GL-ONC1 is well-tolerated at therapeutic dose levels, with documented evidence of antitumor activity. Preclinical studies have further shown synergistic effects with the use of chemotherapy (Cisplatin) and viral therapy with GL-ONC, as well as favorable results when cancer cells are irradiated and then treated with GL-ONC1 in animal models. This Phase I study seeks to evaluate the safety, tolerability and early signs of efficacy of GL-ONC1 administered intravenously in combination with standard of care (SOC) radiation therapy (RT) and cisplatin (CDDP)in patients with locoregionally advanced head and neck cancer. Patients will be individually assessed for safety and dose limiting toxicity. Viral colonization in tumors, replication and anti-tumoral activity will also be evaluated.

Conditions

• Cancer of Head and Neck

Interventions

Type	Name	Description
BIOLOGICAL	GL-ONC1	A genetically-engineered vaccinia virus administered via intravenous infusion . Cohorts 1, 2, 3: Frequency: 1x in Week 1; Cohort 4: 1x again 1x in Week 2; Cohort 5: 1x Week 1, 1x Week 2, 1x Week 3, 1x Week 4.

Timeline

• Start date: 2012-04-01
• Primary completion: 2015-06-01
• Completion: 2015-07-01
• First posted: 2012-04-24
• Last updated: 2015-08-25

Locations

1 site across 1 country: United States