Finding studies
Finding studies
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Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
National Cancer Institute (NCI)
Background: * 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 solid tumors. * This trial is designed to evaluate the safety and efficacy of two different doses of a novel antiangiogenic and immunomodulatory agent, lenalidomide (Revlimid ). Objectives: Primary Objectives: * 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. Secondary Objectives: * 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 pre-clinical studies. * 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 toxicity. Eligibility: * 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 Design: * 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).
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
