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Name of the Trial

Phase III Randomized Study of Percutaneous Isolated Hepatic Arterial Perfusion With Melphalan With Subsequent Venous Hemofiltration Versus Best Alternative Standard Treatment in Patients With Unresectable Liver Metastases Secondary to Ocular or Cutaneous Melanoma (NCI-06-C-0088). See the protocol summary.

Principal Investigator

Dr. James Pingpank Principal Investigator

Dr. James Pingpank, NCI Center for Cancer Research.

Why This Trial Is Important

Some types of cancer, such as melanoma, spread preferentially to the liver, where they may form new tumors called liver metastases. One technique used to treat liver metastases that cannot be surgically removed (unresectable) is called isolated hepatic perfusion (IHP).

In IHP, the flow of blood into and out of the liver is temporarily isolated from the body's circulatory system and high doses of anticancer drugs, such as melphalan, are infused directly into the liver through an artery known as the hepatic artery. This technique allows the delivery of high doses of chemotherapy to liver metastases while sparing the rest of the body from drug exposure.

In this trial, doctors are testing a type of IHP called percutaneous isolated hepatic arterial perfusion (PHP) in patients with liver metastases from ocular (eye) or cutaneous (skin) melanoma. In PHP, catheters inserted through the skin are used to deliver drugs to the liver, block the flow of blood from the liver, and then remove the drugs. In contrast with IHP, this technique avoids the complications of major surgery and can be repeated if necessary.

"With this study, we're comparing treatment with systemic chemotherapy versus a minimally invasive method of delivering chemotherapy regionally to the affected organ," said Dr. Pingpank. "We hope to establish regional chemotherapy as a standard of care for patients with metastatic ocular melanoma, a disease for which no standard therapy currently exists."

Who Can Join This Trial

Researchers seek to enroll 92 patients with liver metastases secondary to ocular or cutaneous melanoma that cannot be surgically removed. See the list of eligibility criteria.

Study Site and Contact Information

This study is taking place at the NIH Clinical Center in Bethesda, Md, and elsewhere. For more information, call the NCI Clinical Trials Referral Office at 1-888-NCI-1937. The call is toll free and confidential.

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