Name of the Trial
Phase II Study of Isolated Hepatic Perfusion with Melphalan Followed by Temozolomide in Patients with Unresectable Hepatic Metastases Secondary to Ocular Melanoma (NCI-03-C-0221). See the protocol summary at http://cancer.gov/clinicaltrials/NCI-03-C-0221.

Principal Investigator
Dr. H. Richard Alexander, NCI Center for Cancer Research

Why is This Trial Important?
Ocular melanoma is the most common cancer of the eye in adults. If left untreated, it can spread (metastasize) to other areas of the body. Most often, ocular melanoma spreads to the liver. No effective treatment currently exists for metastatic ocular melanoma.

In this study, researchers are testing a procedure called hyperthermic isolated hepatic perfusion, which involves temporarily separating the liver's blood supply from the blood circulating throughout the rest of the body. High concentrations of the drug melphalan are then administered to the liver. Once treatment with melphalan is completed, the liver's blood supply is reconnected to the rest of the circulatory system and patients are treated with the drug temozolomide.

"Isolating the liver allows us to deliver a higher dose of melphalan than could be tolerated systemically," said Dr. James Pingpank, a surgeon involved with the trial. "Isolated perfusions have been used to treat cancer in other organs, but this is the first time isolated hepatic perfusion is being used with a large number of patients. The technology just wasn't there before.

"In phase I and II testing, this therapy did produce a response in 62 percent of patients, so it does have established efficacy," said Dr. Pingpank. "Now we are trying to prolong the duration of response, which is currently about 1 year."

Who Can Join This Trial?
Researchers seek to enroll up to 40 patients aged 18 and over who have metastatic liver tumors secondary to ocular melanoma that cannot be removed surgically (unresectable). See the list of eligibility criteria at http://cancer.gov/clinicaltrials/NCI-03-C-0221.

Where Is This Trial Taking Place?
This study is taking place at the NIH Clinical Center in Bethesda, Md.

Whom to Contact
For more information, call the NCI Clinical Studies Support Center (CSSC) at 1-888-NCI-1937. The CSSC provides information about cancer trials taking place on the NIH campus in Bethesda, Md. The call is toll free and confidential.

An archive of "Featured Clinical Trial" columns is available at http://cancer.gov/clinicaltrials/ft-all-featured-trials .