PURPOSE: Pre-clinical models have shown that the effectiveness of GL-ONC1, a modified <p>oncolytic vaccinia virus, is enhanced by radiation and chemotherapy. The purpose of this study</p> <p>was to determine the safety of GL-ONC1 when delivered intravenously with chemoradiotherapy</p> <p>to patients with primary, non-metastatic head and neck cancer.</p> <p>EXPERIMENTAL DESIGN: Patients with locoregionally advanced unresected, non-metastatic</p> <p>carcinoma of the head/neck, excluding stage III-IVA p16-positive oropharyngeal cancers, were</p> <p>treated with escalating doses and cycles of intravenous GL-ONC1, along with radiotherapy and</p> <p>chemotherapy. The primary aims were to define the maximum tolerated dose (MTD) and doselimiting</p> <p>toxicities, and to recommend a dose for phase II trials.</p> <p>RESULTS: Between May 2012 and December 2014, 19 patients were enrolled. The most</p> <p>frequent adverse reactions included grade 1-2 rigors, fever, fatigue, and rash. Grade 3 adverse</p> <p>reactions included hypotension, mucositis, nausea, and vomiting. In 2 patients, the rash was</p> <p>confirmed as viral in origin by fluorescence imaging and viral plaque assay. In 4 patients, viral</p> <p>presence in tumor was confirmed on mid-treatment biopsy by quantitative polymerase chain</p> <p>reaction. In 1 patient, live virus was confirmed in a tongue tumor 7 days after receiving first dose</p> <p>of virus. The MTD was not reached. With median follow-up of 30 months, 1 year (2 year)</p> <p>progression-free survival and overall survival were 74.4% (64.1%) and 84.6% (69.2%)</p> <p>respectively.</p> <p>CONCLUSION: Delivery of GL-ONC1 is safe and feasible in patients with locoregionally</p> <p>advanced head/neck cancer undergoing standard chemoradiotherapy. A phase II study is</p> <p>warranted to further investigate this novel treatment strategy.
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