Lenalidomide (Revlimid) to Treat Advanced Ocular Melanoma
Status:
Completed
Trial end date:
2009-04-01
Target enrollment:
Participant gender:
Summary
This study will test whether an experimental drug called Revlimid (lenalidomide) can reduce
tumor size and prolong survival in patients with metastatic melanoma (melanoma that has
spread beyond the original tumor site). It will also examine the toxicity and blood effects
of Revlimid.
Patients 18 years of age and older with stage IV ocular melanoma may be eligible for this
study. Candidates are screened with a medical history and physical and examination, blood and
urine tests, electrocardiogram, chest x-ray, computed tomography (CT) scan and other imaging
scans if needed, such as a bone scan, magnetic resonance imaging (MRI), ultrasound, or
positron emission tomography (PET).
Participants are admitted to the National Institutes of Health (NIH) Clinical Center for 24
hours for their first oral dose of Revlimid. During the hospital stay, blood is drawn before
the dose is given and again at 0.25, 0.5, 1, 2, 4, 6, 9, 12 and 24 hours after dosing to see
how the body handles the drug. If the drug is well tolerated, patients are sent home with a
21-day supply of drug to take once a day for 21 days, then go off drug 7 days. This regimen
constitutes one 28-day treatment cycle. Treatment cycles may continue for up to 2 years.
Patients keep a daily diary of side effects and have blood drawn once a week. The drug dose
may be adjusted according to the laboratory test results. If unacceptable toxicity occurs,
treatment may be stopped.
Patients who agree to be biopsied undergo this procedure before treatment begins and at the
end of treatment cycles 3 and 6. A small area of skin is numbed with medicine and a small
piece of tumor is removed with a needle or by a small cut in the tumor. The tissue is
examined under a microscope.
Patients return to NIH after the first month of treatment and then every 3 months to evaluate
their tumors and treatment of side effects. The visits include a physical examination, x-rays
and scans to evaluate tumors. Visits are scheduled every 3 months while on treatment; then
every 3 months for 2 years afterwards; then every 4 months for 1 year; and as needed after
that. Patients will have a brain magnetic resonance imaging scan once a year to watch for new
tumor areas.