NCT00482911

Lenalidomide, Sunitinib, and Cyclophosphamide in Treating Patients With Stage IV Eye Melanoma

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: National Institutes of Health Clinical Center (CC) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Intraocular Melanoma
• Malignant Conjunctival Neoplasm

Interventions

Type	Name	Description
DRUG	cyclophosphamide	25-50 mg by mouth once daily on days 1-28.
DRUG	lenalidomide	10 mg by mouth once daily on days 1-28.
DRUG	sunitinib malate	12.5 - 25 mg by mouth once daily on days 1-28.

Timeline

• Start date: 2007-04-01
• Primary completion: 2009-04-01
• Completion: 2009-04-01
• First posted: 2007-06-05
• Last updated: 2017-03-27
• Results posted: 2012-11-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study