Protocol Number: 06-C-0088
-The chemotherapy drug melphalan has been used with some success in treating cancer in the liver. -Melphalan is less toxic if given directly into the blood vessels in the liver instead of through an IV line, and can therefore be given in higher, more effective doses. However, the drug can be given only once this way, because this method requires major surgery. -A different method of giving chemotherapy directly to the liver without a major operation is called peripheral hepatic perfusion (PHP). Special catheters (plastic tubes) called the DelCath system are positioned in the blood vessels going into and out of the liver through small puncture holes in the skin and the melphalan is given through these catheters. Objectives: -To determine if chemotherapy delivered through the DelCath system is effective in treating and shrinking liver tumors. -To determine the number and severity of side effects associated with the DelCath liver perfusion system. Eligibility: -Patients 18 years old or older with eye or skin melanoma that has spread to the liver. -Patients' liver tumors cannot be removed surgically. -Patients whose tumor has spread to limited sites beyond the liver if the tumors outside the liver cannot be treated with surgery and if the life-limiting disease is progressive cancer in the liver. Design: -Participants are randomly assigned to receive standard treatment or liver perfusion with the DelCath system. Liver perfusion is done under general anesthesia. -Patients receiving liver perfusion are admitted to the hospital for 3 to 5 days for the procedure as follows: ---Catheters are placed into the artery that supplies blood to the liver, the vein that drains the liver, and a large vein under the collarbone or in the neck to create a separate circulation for the liver, similar to the heart-lung bypass in open-heart surgery. ---With the catheters in place, melphalan is perfused into the liver for 30 minutes. The circulation to the liver remains separate and the blood is filtered through the DelCath system for another 30 minutes after melphalan is given to remove as much of it as possible from the blood coming out of the liver. ---Patients are observed in the intensive care unit for 24 hours after the procedure. ---Patients may receive liver perfusion treatments about every 4 weeks for up to 6 treatments. -Patients receiving standard treatment may be treated by their referring physician or at the Clinical Center. -Patients in both treatment groups have blood tests and imaging tests at 6 weeks and 12 weeks to evaluate treatment response. These tests are repeated every 2 months the first year, every 3 months the second year, every 4 months the third year, every 6 months the fourth year and yearly thereafter. -Patients receiving liver perfusion whose tumor grows or spreads outside the liver are taken off the study. Patients receiving standard treatment whose tumor grows are offered liver perfusion treatment. -Patients in both groups who go off study continue to be contacted by phone every 6 months for the first 2 years and then each year thereafter. -The study will include 46 patients.
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National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 02/07/2009
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