The project, the Study of Hepatic Arterial Infusion of Melphalan for Malignancy in the liver, can be divided in two parts due to two separate clinical trials. First, NCI 04-C-0273 entitled A Phase II Study of Hepatic Arterial Infusion of Melphalan with Venous Filtration via Peripheral Hepatic Perfusion (PHP) for Unresectable Primary and Metastatic Cancers to the Liver. This trial enrolls patients with primary liver or metastatic disease to the liver. To date 48 patients have enrolled in this study. Each patient has a varied histology including but not limited to metastatic colorectal cancer, primary liver cancer, metastatic ocular melanoma and metastatic neuroendocrine tumors. The second half of the project involves NCI 06-C-0088, A Random-Assignment Study of Hepatic Arterial Infusion of Melphalan with Venous Filtration via Peripheral Hepatic Perfusion (PHP) (Delcath System) Versus Best Alternative Care for Ocular and Cutaneous Melanoma Metastatic to the Liver. This trial is a multi-center phase III trial with NCI being the coordinating center. Currently eight centers are approved and a large effort has been spent in 2008 getting this centers educated, credentialed and mentored in their first procedures. Accrual for this trial stands at 40 patients with an accrual ceiling of 92 patients. During the course of 2008, 26 patients have had a peripheral hepatic perfusion performed here at the clinical center. The procedure takes place in our special procedures unit also known as interventional radiology. Venous and Arterial Access is obtained after informed consent. A diagnostic angiogram is completed to define anatomy and ensure infusion of Melphalan will only be to the liver. Occasional embolizations of the gastro-duodenal artery are necessary to ensure the Melphalan only bathes the liver tumor. Once the anatomy is deemed favorable, then the arterial catheters are placed in the common hepatic artery and the patient is anti-coagulated. The hepatic artery is infused with 3mg/kg (ideal body weight) of Melphalan. A Delcath venous device is used to isolate the blood flow from the liver, remove it via veno-veno bypass and circulate the blood through two filters and back into the patient. After the chemotherapy has been infused, thirty minutes of just filtration is performed. The arterial infusion catheter is removed while the sheath is left in place until the anti-coagulation can be reversed. With this novel treatment strategy, the project hopes to provide an effective means of treating a fatal condition. With the multi-center trial, the technology can be shared and tested for safety. Should the treatment be effective, it will be readily available to those suffering with this type of malignancy. Preliminary data in the form of abstracts and posters have been presented this year and are listed below with title, authors and locations: Pingpank JF, Royal RE, Kammula US, Kam AW, Wood BJ, Alexander HR, Libutti SK, Hughes MS, Ohl SE. High Dose Intra-Arterial Melphalan Delivered via Percutaneous Hepatic Perfusion (PHP) for Patients with Unresectable Hepatic Metastases from Primary Neuroendocrine Tumors. Presented at the American Hepato-Pancreato-Biliary Association Annual Meeting, Ft. Lauderdale, Florida, March 2008. Bartlett EK, Gardner ER, Royal RE, Kammula US, Figg WD, Pingpank JF. Continuous Hemofiltration of Hepatic Venous Effluent Allows Regional Delivery of High-Dose Melphalan via a Minimally Invasive Approach. Poster presentation at the American Hepato-Pancreato-Biliary Association Annual Meeting, Ft. Lauderdale, Florida, March 2008. Bartlett EK, Royal RE, Kammula US, Horne M, Kam AW, Libutti SK, Hughes MS, Wood BJ, Pingpank JF. An Analysis of Coagulation Profiles in Patients Undergoing Venous Hemofiltration after Intra-arterial Chemotherapy for Unresectable Hepatic Malignancies. Presented (Abstract # QS442) at the Third Annual Academic Surgical Congress, Huntington Beach, CA, February 2008. Kam AW, Wood BJ, Chang R, Neeman Z, Chen EA, Royal R, Kammula U, Libutti SK, Hughes M, Alexander HR, Pingpank JF. Technical Considerations in Hepatic Arterial Infusion of High Dose Melphalan with Hepatic Venous Hemofiltration. Presented at the 33rd Annual Meeting of the Society of Interventional Radiology, Washington, DC, March 2008. Pingpank JF, Libutti SK, Royal RE, Kammula US, Alexander HR, Hughes MS, Wood BJ, Kam AW, Ohl SE, Emery B. Impact of High-Dose Melphalan (MEL) administered via Hepatic Arterial Infusion for Patients with Unresectable Hepatic Metastases (LM) from Ocular Melanoma (OM). Poster presentation (Abstract #170) at the 2008 Gastrointestinal Cancer Symposium (ASCO-ASTRO-SSO-AGE), Orlando, FL, January 2008. No definitive manuscripts were published in 2008.
