Dr Tanios Bekaii-Saab, medical director of gastrointestinal oncology at The Ohio State University Comprehensive Cancer Center – Arthur G James Cancer Hospital and Richard J Solove Research Institute (OSUCCC-James), is leading a new, two-arm, randomized phase II pancreatic cancer clinical trial that will study a formulation of the human reovirus that is designed to kill cancer cells.
Expected to enroll approximately 70 patients with pancreatic cancer, both at Ohio State and at other institutions, the study will compare the effects of two courses of treatment. One group of patients will be given the chemotherapy drugs carboplatin and paclitaxel. The other group will be given these two medications plus Reolysin, an engineered version of the human reovirus developed by Oncolytics Biotech Inc of Calgary.
Reolysin works by replicating inside of, and subsequently destroying, cancer cells that have a certain characteristic (called an activated RAS pathway) that is shared by about two-thirds of all cancers. The drug targets tumor cells and leaves healthy, normal cells unharmed. Reolysin appears to kill cancer cells by rupturing their walls.
“Pancreatic cancer is typically diagnosed at a later stage, where there is a poor prognosis for long-term survival,” says principal investigator Bekaii-Saab. “Although the standard of care has evolved over the last few years, it has only managed to generate very modest improvements in response rate and median overall survival at best. Given these poor outcomes, we are eager to evaluate new and promising treatments in this indication.”
Led by Bekaii-Saab, the research team will monitor both sets of patients, who will receive intravenous doses of medication every three weeks and undergo CT scans for tumor response assessment every eight weeks. Patients whose condition does not improve with carboplatin and paclitaxel alone will have Reolysin added to their treatment.
The American Cancer Society estimates that 43,140 Americans were diagnosed with pancreatic cancer in 2010, and about an equal number of patients died from the disease.
The study is sponsored by the Cancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis, US National Cancer Institute, which is a part of the National Institutes of Health.
Researchers at OSUCCC-James are also conducting clinical trials with Reolysin in patients who have lung cancer and ovarian cancer.