St. Luke’s Becomes First in the Region to Serve as a Lead Institution of a National Multi-Center Clinical Study on Melanoma
St. Luke's University Health Network has been awarded a grant from pharmaceutical supporter Merck to serve as the lead Sponsor-Investigator on a Multi-Site Investigator-Initiated Trial (IIT) to study the health-related quality of life of melanoma patients receiving interferon therapy.
Internationally recognized melanoma investigator Sanjiv Agarwala, MD, chief of Medical Oncology and Hematology, St. Luke's University Health Network, is serving as the principal investigator and sponsor. Agarwala developed the idea and the protocol for the study, obtaining the interest of funding supporter Merck and securing the grant to bring the study to fruition.
"Interferon therapy is a proven treatment and has been used for many years to treat patients with advanced melanoma," Agarwala said. "It works by helping to activate cancer-fighting immune cells and prohibit the replication and growth of existing cancer cells. While offering patients effective treatments to extend life is vitally important to our cancer patients, improving the quality of life in the process is equally significant. This study will help us learn more about quality of life factors so important to melanoma patients and all patients faced with a life-threatening disease."
To qualify for the study, patients must be at least 18 years of age and have first received a surgical resection for melanoma. Trial participants also must be willing to undergo interferon therapy.
The St. Luke's University Health Network Clinical Trials Office – under the leadership of Tracy Butryn, MS, CCRP, director of Clinical Trials and Research, and Rose Cabral, RN, BSN, OCN, manager of Oncology Integrated Clinical Trials – is responsible for overall study coordination, data collection and regulatory oversight of approximately 10 other sub-sites across the nation. Three patients have been enrolled since the study opened Dec. 6, 2013 at St. Luke's. The accrual goal is 100 patients.
"This initiative would not have been possible without the dedication and knowledge of Dr. Agarwala, an internationally renowned expert in the field of melanoma and his relationships with leading industry supporters," Butryn said. "Additionally, the St. Luke's centralized Clinical Trials Office has the expertise and infrastructure in place to coordinate and execute a national clinical study of this caliber."
For study details, please visit www.clinicaltrials.gov and enter trial ID #01986712 in the search bar. For more information, call St. Luke's Network Clinical Trials office at 484-503-4151.