Intraocular Melanoma Clinical Trial
Official title:
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
RATIONALE: Lenalidomide may stop the growth of tumor cells by blocking blood flow to the
tumor. Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed
for cell growth. Drugs used in chemotherapy, such as cyclophosphamide, work in different
ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. Giving lenalidomide together with sunitinib and low doses of cyclophosphamide once
a day may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving lenalidomide together with
sunitinib and cyclophosphamide works in treating patients with stage IV eye melanoma.
OBJECTIVES:
Primary
- Determine the response rate in patients with stage IV ocular melanoma treated with
lenalidomide, sunitinib malate, and low-dose metronomic cyclophosphamide.
Secondary
- 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
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