Lenalidomide, Sunitinib, and Cyclophosphamide in Treating Patients With Stage IV Eye Melanoma
Condition: Intraocular Melanoma; Malignant Conjunctival Neoplasm
MeSH terms: Melanoma; Conjunctival Neoplasms
Intervention: cyclophosphamide; lenalidomide; sunitinib malate
Intervention description: 25-50 mg by mouth once daily on days 1-28.; 10 mg by mouth once daily on days 1-28.; 12.5 - 25 mg by mouth once daily on days 1-28.
Intervention MeSH terms: Cyclophosphamide; Lenalidomide; Sunitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: recurrent intraocular melanoma; metastatic intraocular melanoma; ciliary body and choroid melanoma, medium/large size; extraocular extension melanoma; iris melanoma; conjunctival melanoma

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.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed ocular melanoma

               -  Stage IV disease

          -  Measurable disease

          -  No active brain metastases

               -  Patients with brain metastases must have had a complete excision or radiotherapy
                  and remain asymptomatic with stable disease by magnetic resonance imaging (MRI)
                  or computed tomography (CT) scan for ≥ 6 months

        PATIENT CHARACTERISTICS:

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2

          -  Life expectancy > 3 months

          -  Granulocyte count > 1,500/mm^3

          -  Platelet count > 100,000/mm^3

          -  Creatinine ≤ 1.5 mg/dL OR creatinine clearance > 60 mL/min

          -  Bilirubin ≤ 2.0 mg/dL

          -  Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 10 times upper
             limit of normal (ULN)

          -  Prothrombin time (PT)/partial thromboplastin time (PTT)/International Normalized Ratio
             (INR) normal

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use one highly effective method of contraception (with an
             additional method) or barrier methods of contraception for ≥ 4 weeks before, during,
             and for ≥ 4 weeks after completion of study therapy

          -  Ejection fraction normal by echocardiogram

          -  No acute, critical illness, including serious untreated infection

          -  No history of any of the following:

               -  Unstable or newly diagnosed angina pectoris

               -  Myocardial infarction within the past 6 months

               -  New York Heart Association class II-IV heart disease

               -  Congestive heart failure

               -  Chronic obstructive lung disease requiring oxygen therapy

               -  Chronic uncontrollable hypertension

               -  Uncontrolled seizure activity

          -  No known human immunodeficiency virus (HIV) positivity

          -  No known hypersensitivity reaction to thalidomide, lenalidomide, sunitinib malate, or
             cyclophosphamide

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  Recovered from all prior therapy

          -  At least 4 weeks since prior surgery, chemotherapy (6 weeks for mitomycin C,
             nitrosoureas, or carboplatin), hormonal therapy, radiotherapy, or biological therapy

          -  No concurrent grapefruit or grapefruit juice

          -  No other concurrent antitumor therapy