A Phase II Study of Combination Oral CC-5013 Lenalidomide (Revlimid™), Oral Sunitinib (Sutent™) and Low Dose Oral Metronomic Cyclophosphamide for the Treatment of Stage IV Ocular Melanoma
- Determine the response rate in patients with stage IV ocular melanoma treated with
lenalidomide, sunitinib malate, and low-dose metronomic cyclophosphamide.
- Determine the toxicity of this regimen in these patients.
- Determine the progression-free survival of patients treated with this regimen.
- Obtain blood, urine, and tissue samples from these patients, when easily accessible, to
determine the effects of this regimen on pathways thought to have been modulated by
this regimen in pre-clinical studies.
OUTLINE: This is nonrandomized, uncontrolled, open-label study.
Patients receive oral lenalidomide, oral sunitinib malate*, and oral low-dose
cyclophosphamide once daily on days 1-28. Treatment repeats every 28 days for up to 2 years
in the absence of disease progression or unacceptable toxicity.
NOTE: *Some patients will not receive sunitinib malate during course 1.
After completion of study treatment, patients are followed every 3 months for 2 years, every
4 months for 3 years and then annually thereafter.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Response Rate (Complete and Partial Response)
Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is the disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.
Steven K. Libutti, MD
NCI - Surgery Branch
United States: Food and Drug Administration
|Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office||Bethesda, Maryland 20892-1182|