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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Related Information
Registry Information

Alternate Title

Phase II Randomized Study of Lenalidomide in Patients With Stage IV Ocular Melanoma

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over NCI NCI-05-C-0095 NCI-P6501, NCT00112606

Special Category: NCI Web site featured trial

Trial Description

Purpose:

Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop tumor cells from growing. Lenalidomide may also stop the growth of eye melanoma by blocking blood flow to the tumor.

This randomized phase II trial is studying two different doses of lenalidomide to see how well it works in treating patients with eye melanoma.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Measurable disease
• No brain metastases
• Not pregnant or breastfeeding
• No previous lenalidomide
• At least 4 weeks since biological therapy, chemotherapy, hormone therapy, radiation therapy, or surgery
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will be randomly assigned (have an equal chance of being placed) to one of two groups.

Patients in group one will receive lenalidomide by mouth once a day for 3 weeks.

Patients in group two will receive lenalidomide as in group one at a higher dose.

Treatment in both groups may repeat every 4 weeks for up to 2 years.

Patients will be evaluated at 1 month, once a month for 2 months, and every 3 months thereafter.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research

Steven Libutti, MD, Principal investigator		Ph: 301-496-5049 Email: steven_Libutti@nih.gov

Related Information

Featured trial article

Registry Information
Official Title		A Phase II Randomized Study of Oral CC-5013 Lenalidomide (Revlimid), an Antiangiogenic and Immunomodulatory Agent in Subjects with Stage IV Ocular Melanoma
Trial Start Date		2005-04-25
Registered in ClinicalTrials.gov		NCT00112606
Date Submitted to PDQ		2005-04-25
Information Last Verified		2008-04-27