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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

Brief 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 Summary:

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.


Sponsor: National Institutes of Health Clinical Center (CC)

Current Primary Outcome:

  • Response Rate (Complete and Partial Response) [ Time Frame: 2 years ]
    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.
  • Toxicity [ Time Frame: 16 months ]
    Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.
  • Overall Survival [ Time Frame: up to 16 months ]
    Time from date of on study to the date of death from any cause or last follow up


Original Primary Outcome:

  • Response rate (complete and partial)
  • Toxicity


Current Secondary Outcome:

  • Progression Free Survival [ Time Frame: up to 16 months ]
    Proportion of patients who progress or die after the start of treatment
  • Changes in Gene Expression, Methylation and Protein Modification [ Time Frame: Baseline and end of treatment course 1 and 2, approximately 42 days ]
    Ribonucleic acid (RNA), deoxyribonucleic acid (DNA) and protein obtained from blood, urine and/or tissue was to be evaluated for changes in gene expression, methylation and/or protein modification.


Original Secondary Outcome:

  • Progression-free survival
  • Overall survival


Information By: National Institutes of Health Clinical Center (CC)

Dates:
Date Received: June 4, 2007
Date Started: April 2007
Date Completion:
Last Updated: February 6, 2017
Last Verified: February 2017