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University of Maryland Cancer Specialists Test New Procedure to Treat Melanoma That Has Spread to the Liver

Tuesday, May 12, 2009

Treatment bathes liver with chemotherapy, then filters the drug from the blood

Cancer specialists at the University of Maryland Marlene and Stewart Greenebaum Cancer Center in Baltimore are testing a new procedure to treat melanoma that has spread to the liver, targeting tumors with a dose of chemotherapy that is 10 times stronger than patients could otherwise tolerate.

The procedure is called percutaneous hepatic perfusion. Doctors use a specially designed delivery system with catheters and filters to make sure the cancer-fighting drug is applied only to the liver, thereby reducing the risk of damaging nearby organs and minimizing possible side effects for patients.

“This new procedure enables us to give patients extremely high doses of chemotherapy directly to the liver, where studies have shown it can be most effective in shrinking or eliminating tumors,” says H. Richard Alexander, Jr., M.D., a surgical oncologist at the Greenebaum Cancer Center who is one of the leaders of the Phase III clinical study. “Patients wouldn’t be able to tolerate this high-dose chemotherapy given intravenously to the entire body, but they generally tolerate this procedure quite well, with very few side effects.”

“Initial results have been promising. Half of the people in the Phase I study had their tumors shrink as a result of the treatment. In two people, the tumors disappeared altogether,” says Dr. Alexander, who is also a professor of surgery and associate chairman of clinical research in the Department of Surgery at the University of Maryland School of Medicine.
He says that although the study focuses on melanoma, this treatment might also be useful to treat other cancers that have spread to the liver, such as colon cancer or breast cancer.

Dr. Alexander was instrumental in researching and developing this new technique while he was a leader in clinical research at the National Cancer Institute (NCI).  He was deputy director of the NCI’s Center for Cancer Research when he joined the University of Maryland Greenebaum Cancer Center in 2006. The Greenebaum Cancer Center is part of the University of Maryland School of Medicine and the University of Maryland Medical Center.

Delcath Systems, Inc., a medical technology company specializing in cancer treatment, makes the delivery system, which is being tested at the NCI, the Greenebaum Cancer Center and a number of other top cancer centers across the country. Melanoma patients with inoperable tumors in the liver are eligible to enroll in the study. Their cancer may begin in either the skin (cutaneous melanoma) or the eye (ocular melanoma).

“Once melanoma – in particular ocular melanoma – has spread to the liver, it can be very aggressive and extremely difficult to treat,” says Dr. Alexander. “Patients really don’t have a lot of options, so we’re very hopeful that this new targeted chemotherapy will prove to be effective.”

More than 62,000 people are diagnosed with melanoma each year in the United States. Ocular melanoma is much rarer, with about 2,500 new cases detected each year. The cancer is often lethal if it spreads to the liver, which is the most common site for it to metastasize.

Patients enrolled in the study are selected at random to receive either the new targeted treatment or an alternative therapy, such as intravenous or oral chemotherapy. However, those who receive the alternative therapy can opt to have the new procedure if the tumors do not respond to the alternative therapy and continue to grow.

Under the protocol, patients receive infusions of a chemotherapy drug, melphalan, for 30 minutes every four weeks. They can receive a total of four to six treatments. The procedure is performed in an operating room or interventional radiology suite while the patient is under an anesthetic. Doctors thread a catheter up through a major artery in the patient’s groin into the main artery that feeds the liver to deliver the chemotherapy. Another catheter is placed in the major vein behind the liver, and balloons on the catheter are inflated to direct all the blood flowing out of the liver into a filter. This filter system removes almost 90 percent of the chemotherapy from the blood, and the blood is then given back to the patient through a catheter placed in a large vein in the neck.

“This technique involves only a couple of small holes to place the catheters, so patients generally recover quickly and are released from the hospital in a day or two,” says Fred Moeslein, M.D., Ph.D., an interventional radiologist and an assistant professor of diagnostic radiology and nuclear medicine at the University of Maryland School of Medicine who performs the procedure. Side effects may include fatigue and lower red and white blood cell counts.

E. Albert Reece, M.D., Ph.D., M.B.A., vice president for medical affairs, University of Maryland, and dean of the University of Maryland School of Medicine, says, “This study is just one of a number of innovative clinical trials being conducted by University of Maryland School of Medicine researchers to develop effective new treatment options for patients facing very devastating diseases. We’re very pleased that Dr. Alexander is playing a leading role in testing this exciting new technology.”

Delcath hopes to have 96 patients participate in the multi-center study. About half of the patients already have been enrolled. For more information about the clinical trial, go to http://data.umms.org/scripts/trials/trial.cfm?ID=GCC0636

To learn more about the University of Maryland Marlene and Stewart Greenebaum Cancer Center, visit www.umgcc.org.

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