Crizotinib in High-Risk Uveal Melanoma Following Definitive Therapy

Inclusion Criteria

• •Primary diagnosis of uveal melanoma at least 12 mm in largest basal diameter as clinically determined by the treating investigator. Cytologic determination of diagnosis is not required. Size is based on clinical assessment (e.g. by ultrasound or direct ophthalmoscopy) prior to enucleation or radiation therapy.
• •Definitive therapy of the primary uveal melanoma must have been performed within 90 days of initiating protocol therapy.
• •High-risk (class 2) uveal melanoma as determined by gene expression profiling
• •No evidence of metastatic disease.
• •Age ≥18 years.
• •Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 (Karnofsky ≥ 70%.
• •Life expectancy of greater than 3 months.
• •Able to swallow and retain orally-administered medication and does not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels
• •Patients must have normal organ and marrow function as defined below:
• •Absolute neutrophil count (ANC) \>1,000 cells/mm³
• •Platelet count \>75,000/mm³
• •Hemoglobin \>9.0g/dL
• •Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \<3x upper limited of normal (ULN)
• •Total bilirubin \<2x ULN
• •Alkaline phosphatase \<3x ULN
• •Serum creatinine \<2x ULN or a creatinine clearance \> 60mL/min
• •Note: Patients with hyperbilirubinemia clinically consistent with an inherited disorder of bilirubin metabolism (e.g., Gilbert syndrome) will be eligible at the discretion of the treating physician and/or the principal investigator.
• •Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation until 4 months after completion of crizotinib administration. Women of child-bearing potential must have a negative serum pregnancy test within 14 days prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study therapy, and 4 months after completion of crizotinib administration.
• •Ability to understand and the willingness to sign a written informed consent document.