Moffitt is the seventh center in this multi-center trial using the Delcath System. Delcath and Moffitt have entered into a clinical research agreement to conduct the Phase III National Cancer Institute (NCI) led study.
The Phase III study is designed to test Delcath’s proprietary percutaneous hepatic perfusion (PHP) system for the regional delivery of melphalan to the liver to treat patients with metastatic ocular and cutaneous melanoma who have unresectable tumors in the liver.
The Delcath System is designed to deliver significantly higher doses of anti-cancer drugs to a patient’s liver while preventing entry of the drugs to the rest of the patient’s circulation. This isolation limits toxicities that result from systemic chemotherapy treatments.
Patients in the Phase III trial initially are randomized into one of two treatment arms, including immediate treatment with melphalan via the Delcath System or treatment with best alternative care.
The study is designed to evaluate the duration of tumor response in each of the two study arms. Following guidelines established by FDA under a special protocol assessment, when disease progresses in patients enrolled in the best alternative care arm of the trial, they are permitted to ‘cross over’ and receive treatment with the Delcath System.
The Phase III study, which recently exceeded 33% enrollment, is expected to be completed in 2009, leading to an application to the FDA for commercial approval of the PHP system.