Safety Study of Attenuated Vaccinia Virus (GL-ONC1)With Combination Therapy in Head & Neck Cancer
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Safety and Tolerability as measured by the number of patients with Adverse Events, as well as type of AE and frequency [ Time Frame: Baseline up to week 23 Post-treatment ] [ Designated as safety issue: Yes ]Evaluation of changes in laboratory tests (hematological, chemistry), immunogenicity and physical examination
- Presence of Virus in Tumor [ Time Frame: At baseline (Within 4 weeks of Treatment Day 1); 9-13 days post viral injection ] [ Designated as safety issue: No ]Analysis of tumor tissue (obtained through surgical or core biopsy if accessible from consenting patients) following viral treatment.
- Determine Initial Susceptibility of tumor to viral infection [ Time Frame: At baseline (Within 4 weeks of Treatment Day 1) ] [ Designated as safety issue: No ]Evaluate susceptibility of initial biopsied tumor to viral infection in cell cultures (for patients consenting to biopsy and where tumor is accessible).
- Anti-Tumor Activity (Early Efficacy) [ Time Frame: Change from baseline up to week 23 Post-treatment (week 23) ] [ Designated as safety issue: No ]Assessing changes in tumor measurement through physical examination, CT or CT/PET scan
|Study Start Date:||April 2012|
|Estimated Study Completion Date:||August 2015|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01584284
|United States, California|
|Moores UC San Diego Cancer Center|
|La Jolla, California, United States, 92037|
|Principal Investigator:||Loren K Mell, MD||Moores UC San Diego Cancer Center|