A Randomized Phase II Study of Oral Lenalidomide (Revlimid [TM]), an Antiangiogenic and Immunomodulatory Agent, in Subjects With Stage IV Ocular Melanoma
- Patients with stage IV ocular melanoma have very few available treatment options and an
overall poor prognosis.
- Pre-clinical and early clinical evidence suggest that lenalidomide has activity against
- This trial is designed to evaluate the safety and efficacy of two different doses of a
novel antiangiogenic and immunomodulatory agent, lenalidomide (Revlimid ).
- Determine the response rate to lenalidomide at two dose levels for patients with Stage
IV ocular melanoma.
- To determine the toxicity of lenalidomide at two dose levels in this setting.
- To determine the progression free and overall survival of patients with Stage IV ocular
melanoma treated with lenalidomide.
- When easily accessible, obtain tissue at baseline and during therapy to evaluate the
effects of these agents on pathways, thought to be modulated by lenalidomide in
- To determine the pharmacokinetics of lenalidomide at these two doses in patients with
Stage IV ocular melanoma.
- To determine if there is a dose level with potentially superior efficacy and acceptable
- Patients > 18 years of age with stage IV ocular melanoma, who have measurable disease.
- Patient must be Eastern Cooperative Oncology Group (ECOG) performance status of = 2 and
a life expectancy of more than 3 months.
- Patients must have adequate organ function.
- 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,.
- All patients who are sexually active and able to conceive will be required to use
contraception during treatment with lenalidomide
- A phase II trial in which patients are randomized to 2 dose levels of lenalidomide
administered for 21 days every 28 days for 2 years.
- 76 patients (allowing for up to 3 inevaluable patients per dose level) will be enrolled
over 4 to 5 years.
- The objective of the trial will be to determine in each of the two groups of patients
(5 mg and 25 mg dose levels) whether, CC5013 is able to be associated with a response
rate (partial response (PR) + complete response (CR)) that can rule out 10% (p0=0.10)
in favor of an improved response rate of 30% (p1=0.30).
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Clinical Responses in Patients With Metastatic Ocular Melanoma
Clinical response is assessed by the Response Evaluation Criteria for Adverse Events in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Steven K Libutti, M.D.
National Cancer Institute, National Institutes of Health
United States: Federal Government
|National Cancer Institute (NCI)||Bethesda, Maryland 20892|