Summary
The Delcath Systems Percutaneous Hepatic Perfusion (PHP) trial to treat patients with metastatic melanoma has completed enrollment and now must track patients, record data, and analyze results.
This trial was apparently enrolled on schedule and the company is targeting 2010 for FDA regulatory submission.
Analysis
This trial is significant for several reasons:
1. It investigates a novel technology which, if approved, would be the first device that allows a non-invasive approach to isolated chemotherapy treatment of hepatic metastases, which until now has required extensive, morbid, surgery. It is important to distinguish the older, complex, procedure, called Isolated Hepatic Perfusion in the medical literature, from PHP.
2. This trial allowed patients with metastatic uveal (ocular) melanoma to enroll. Often, treatment trials for metastatic melanoma will exclude those patients, since uveal melanoma is genetically distinct from the more common cutaneous (skin) form. There are currently no approved or generally accepted treatments for metastatic uveal melanoma. Therefore, potential FDA approval of the Delcath device would likely include the first approval of treatment for this metastatic cancer.
