Name of the Trial
Phase II Randomized Study of Lenalidomide in Patients with Stage IV Ocular Melanoma (NCI-05-C-0095). See the protocol summary at http://cancer.gov/clinicaltrials/NCI-05-C-0095.

Principal Investigator
Dr. Steven Libutti, NCI Center for Cancer Research

Why This Trial Is Important
Ocular melanoma is cancer that forms in melanocytes (cells that produce the pigment melanin) in the eye. It is the most common primary eye cancer in adults. Although surgery and/or radiation therapy may be effective for disease that is limited to the area around the eye, no effective treatment is currently available for ocular melanoma that has spread (metastasized) to other organs (stage IV disease).

In this trial, researchers are testing a new drug called lenalidomide (Revlimid) to see if it can stop or slow the growth of ocular melanoma metastases and help patients live longer. Researchers will compare two different doses of the drug to assess its antitumor activity and possible side effects. Lenalidomide is thought to inhibit the growth of new blood vessels to tumors (a process called angiogenesis), thereby restricting the supply of nutrients needed for tumor growth. It may also possess other antitumor activities, such as stimulating the immune system and promoting tumor cell apoptosis (suicide).

"Lenalidomide is a novel antiangiogenic agent that we hope can help shrink tumors in patients with metastatic ocular melanoma," said Dr. Libutti. "This trial will help us determine whether lenalidomide can produce meaningful inhibition of tumor vasculature and what effects such inhibition has on the growth of these tumors."

Who Can Join This Trial
Researchers seek to enroll up to 38 patients aged 18 or over with metastatic ocular melanoma. See the list of eligibility criteria at http://cancer.gov/clinicaltrials/NCI-05-C-0095.

Study Site and Contact Information
This study is taking place at the NIH Clinical Center in Bethesda, Md. For more information, call the NCI Clinical Studies Support Center (CSSC) at 1-888-NCI-1937. The toll-free call is confidential.