Expired Study
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Bethesda, Maryland 20892


Purpose:

RATIONALE: Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop tumor cells from growing. Lenalidomide may also stop the growth of eye melanoma by blocking blood flow to the tumor. PURPOSE: This randomized phase II trial is studying two different doses of lenalidomide to see how well it works in treating patients with eye melanoma.


Study summary:

OBJECTIVES: Primary - Determine the response rate in patients with stage IV ocular melanoma treated with two different doses of lenalidomide. - Determine the toxicity of this drug in these patients. Secondary - Determine the progression-free and overall survival of patients treated with this drug. - Determine the pharmacokinetics of this drug in these patients. - Compare the efficacy and acceptable toxicity of this drug in these patients. OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive oral lenalidomide once daily on days 1-21. - Arm II: Patients receive lenalidomide as in group one at a higher dose. In both arms, courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 1 month, monthly for 2 months, and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 12-38 patients will be accrued for this study within 2-3 years.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed ocular melanoma - Stage IV disease - Measurable disease - No evidence of active brain metastases - Prior brain metastases treated with complete excision or radiotherapy allowed provided disease remains asymptomatic and stable for ≥ 6 months by MRI of the brain PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - More than 3 months Hematopoietic - Granulocyte count > 1,500/mm^3 - Platelet count > 100,000/mm^3 Hepatic - Bilirubin ≤ 2.0 mg/dL - ALT and AST < 10 times upper limit of normal Renal - Creatinine ≤ 1.5 mg/dL OR - Creatinine clearance > 60 mL/min Cardiovascular - No New York Heart Association class II-IV congestive heart failure - No history of unstable or newly diagnosed angina pectoris - No myocardial infarction within the past 6 months Pulmonary - No chronic obstructive lung disease requiring oxygen therapy Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use 2 forms of effective contraception 1 month prior to, during, and for 1 month after completion of study treatment - No known HIV positivity - No known hypersensitivity reaction to thalidomide - No uncontrolled seizure activity - No serious untreated infection - No other acute or critical illness PRIOR CONCURRENT THERAPY: Biologic therapy - At least 4 weeks since prior biologic therapy - No prior lenalidomide Chemotherapy - At least 4 weeks since prior chemotherapy (6 weeks for mitomycin, nitrosoureas, or carboplatin) Endocrine therapy - See Disease Characteristics - At least 4 weeks since prior hormonal therapy Radiotherapy - See Disease Characteristics - At least 4 weeks since prior radiotherapy Surgery - See Disease Characteristics - At least 4 weeks since prior surgery Other - Recovered from all prior therapy - No other concurrent antitumor therapy


NCT ID:

NCT00112606


Primary Contact:

Principal Investigator
Steven K. Libutti, MD
NCI - Surgery Branch


Backup Contact:

N/A


Location Contact:

Bethesda, Maryland 20892
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 15, 2017

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