INCLUSION CRITERIA:
-All patients with stage IV ocular melanoma who have measurable disease will be considered.
-Patients must be greater than or equal to 18 years of age.
-Patients must have histopathological documentation of ocular melanoma confirmed in the Laboratory of Pathology/NCI of the Clinical Center at the National Institutes of Health. This can be from tissue obtained outside the NIH.
-Patient must be ECOG performance status of less than or equal to 2.
-Patients must have a life expectancy of more than 3 months.
-Patients must be able to understand and sign informed consent form.
-Patients must be willing to return to the NIH for follow-up visits.
-Patients must not have had prior surgery, chemotherapy, hormonal therapy, radiation therapy, or biological therapy for at least 4 weeks prior to starting study medication.
-Patients who were receiving mitomycin C, nitrosoureas, or carboplatin must be 6 weeks from the last administration of chemotherapy.
-Patients must have recovered from any acute toxicity related to prior therapy or surgery, to a grade 1 or less unless specified.
-Patients must not have an acute, critical illness, including a serious untreated infection.
-Patients must have a normal ejection fraction measured by a echocardiogram.
-Hematological eligibility parameters (prescreen):
Granulocyte count greater than 1,500/mm3.
Platelet count greater than 100,000/mm3.
-If the creatinine is greater than 1.5 mg/dL, obtain a 24 hour urine collection. Creatinine clearance must be greater than 60 mL/min/1.73m2.
-Hepatic function: bilirubin (total) less than or equal to 2.0 mg/dl; ALT less than 10 times upper limit of normal; AST less than 10 times upper limit of normal.
-Coagulation parameters (PT/PTT or INR) within normal limits.
-All patients who are sexually active and able to conceive will be required to use contraception during treatment with lenalidomide, sunitinib and low dose metronomic cyclophosphamide.
-Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10-14 days prior to and again within 24 hours of starting lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a vasectomy. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure.
EXCLUSION CRITERIA:
-Patients with evidence of active brain metastases will be excluded. Patients must have had a complete excision or radiotherapy and remain asymptomatic with stable disease as shown by MRI or CT for at least six months.
-Patients who are pregnant or lactating. No data is currently available about the excretion of these agents in breast milk. Although no preclinical data suggest teratogenicity with lenalidomide, because of the relationship to thalidomide, we will exclude patients who are pregnant or lactating.
-Patients with a history of unstable or newly diagnosed angina pectoris, recent myocardial infarction (within 6 months of enrollment), New York class II-IV, congestive heart failure, chronic obstructive lung disease requiring oxygen therapy, chronic uncontrollable hypertension, or uncontrolled seizure activity are not eligible. (refer to Table 3)
-Patients who are known positive for HIV as it may increase their risk of infection since lenalidomide has effects on cells involved in the immune system.
-Patients with known hypersensitivity reaction to thalidomide, lenalidomide, sunitinib or cyclophosphamide.
National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 09/20/2008