INCLUSION CRITERIA:
- All patients with stage IV ocular melanoma, who have measurable disease will be considered.
- 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.
- Hematological eligibility parameters (prescreen):
1. Granulocyte count greater than 1,500/mm3
2. Platelet count greater than 100,000/mm3
3. If the creatinine is greater than1.5 mg/dL, obtain a 24 hour urine collection. Creatinine clearance must be greater than 60 mL/min/1.73m2.
4. Hepatic function: bilirubin (total) less than or equal to 2.0 mg/dl; ALT less than 10 x upper limit of normal; AST less than 10 x upper limit of normal.
- Patients must have recovered from any acute toxicity related to prior therapy or surgery, to a grade 1 or less unless specified above.
- 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 not have an acute, critical illness, including a serious untreated infection.
- Patients must be willing to return to the NIH for follow-up visits.
- All patients who are sexually active and able to conceive will be required to use contraception during treatment with lenalidomide.
Only two criteria are allowed by the FDA for the status of not of child bearing potential: hysterectomy or menopausal for 24 consecutive months. Women of child bearing potential will be required to use two methods of birth control, one highly effective method and one additional method, at the same time during treatment and for one month after the completion of lenalidomide treatment. These methods must be used for at least four weeks before starting lenalidomide, during treatment, and for at least four weeks following the last dose of lenalidomide. Acceptable forms of birth control include:
Highly Effective Methods:
Intrauterine device (IUD)
Hormonal (Birth control pills, injections, implants)
Tubal ligation
Partner's vasectomy
Additional Effective Methods:
Latex condom
Diaphragm
Cervical cap
Two barrier methods may be used if the physician agrees that the highly effective methods are medically contraindicated.
Women of childbearing potential must have a negative urine pregnancy test 24 hours prior to the start of lenalidomide.
Men who are sexually active must agree to use latex condoms.
- Patients must be able to understand and sign informed consent form.
-Patients must be greater than or equal to 18 years of age.
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 for at least six months.
- Patients who are pregnant or lactating. No data is currently available about the excretion of lenalidomide in breast milk. Although no preclinical data suggest teratogenicity with this compound, 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 or uncontrolled seizure activity are not eligible.
- 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 who have had prior therapy with lenalidomide.
- Patients with known hypersensitivity reaction to thalidomide.
National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 09/15/2008