This Phase III multi-center study is led by the National Cancer Institute (NCI) and is enrolling at cancer centers throughout the US. Delcath has finalized a clinical research agreement with St Luke’s.
The Phase III study is designed to test Delcath’s 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 PHP System is designed to deliver significantly higher doses of anticancer 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 PHP 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.
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 Delcath PHP System.
Richard Taney, president and CEO of Delcath Systems, said: “Delcath continues to expand this Phase III study to leading cancer centers and we welcome this collaboration with St Luke’s, as it further allows the Delcath PHP System to reach patients who can benefit from this treatment option.”