Protocol Number: 07-C-0134
Patients with advanced ocular melanoma (a rare form of eye cancer) have very few treatment options. Recent research shows that combinations of lenalidomide, sunitinib and cyclophosphamide can slow tumor growth in mice. Objectives: To determine if combination therapy with lenalidomide, sunitinib and cyclophosphamide can reduce tumor size and prolong survival in patients who have metastatic ocular melanoma (ocular melanoma that has spread beyond the eye). Eligibility: Patients 18 years of age and older with stage IV ocular melanoma. Design: Patients take lenalidomide, sunitinib and cyclophosphamide daily in 28-day cycles for up to 2 years. Patients keep a record (diary) of their daily dosing, side effects of the medicines and any other health problems that may develop during the study period. They fax this diary to researchers at the end of each treatment cycle. In addition, patients have the following tests and procedures: -Blood tests, scans and x-rays at the end of each cycle to monitor the cancer. -Visits to NIH every month for 4 months and then every 4 months until the study ends for evaluations, which include a physical examination, blood tests, and review of their diary. -MRI and CT scans of the brain every year. -Tumor biopsies (surgical removal of a small piece of tumor tissue, if the tumor is easy to biopsy) to examine the effect of the study drugs on the cancer. Biopsies may be done before starting the study drugs and again at the end of the first and second treatment cycles.
Search The Studies | Help | Questions |
National Institutes of Health Clinical Center |
||