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
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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety and Tolerability as measured by the number of patients with Adverse Events, as well as type of AE and frequency
Evaluation of changes in laboratory tests (hematological, chemistry), immunogenicity and physical examination
Baseline up to week 23 Post-treatment
Yes
Loren K Mell, MD
Principal Investigator
Moores UC San Diego Cancer Center
United States: Food and Drug Administration
GL-ONC1-005
NCT01584284
April 2012
April 2014
Name | Location |
---|---|
Moores UC San Diego Cancer Center | La Jolla, California 92093 |