The study is designed to determine the 32 month rate of distant relapse in patients with uveal melanoma who are at high risk of recurrence following definitive therapy with surgery or radiation who receive adjuvant crizotinib; and secondarily, the overall survival and disease specific survival in this patient population.
Uveal melanoma is the most common primary intraocular malignancy in adults, and arises from melanocytes within the choroid plexus of the eye. Melanomas of the ocular and adnexal structures comprise approximately 5% of all melanomas and are biologically and prognostically distinct from cutaneous melanoma. In the United States, an estimated 2000 patients are diagnosed with this disease each year. The development of metastasis in this disease is common and occurs in approximately 50% of patients with posterior uveal melanoma within 15 years after the initial diagnosis and treatment. Uveal melanoma is thought to be particularly resistant to systemic treatment, and no systemic therapy has yet been demonstrated to improve survival. Drugs commonly used to treat advanced cutaneous melanoma rarely achieve durable responses in patients with uveal melanoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
34
An anti-cancer drug acting as an anaplastic lymphoma kinase (ALK) and c-ros oncogene 1 (ROS1) inhibitor, used to treat non-small cell lung cancer (NSCLC) that has spread to other parts of the body and is caused by a defect in a gene called ALK. Crizotinib will be provided as capsules containing 200 or 250 mg of study medication for oral administration.
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States
Columbia Univeristy Medical Center
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
The Ohio State University
Columbus, Ohio, United States
Relapse Free Survival (RFS) Rate at 32 Months
RFS rate will be defined as the percentage of patients who do not experience any new tumor growth at any site on the body distant from the primary site or death from any cause from the time of study entry to the end of the relevant timepoint. RFS probabilities were estimated using Kaplan-Meier method.
Time frame: 32 Months
Overall Survival (OS)
OS will be defined as the time from treatment start to date of death or last followup. Participants were followed up to 36 months after treatment start and Kaplan-Meier survival analysis was used to generate the Overall Survival estimate.
Time frame: Up to 36 months
Disease-Specific Survival (DSS) Time
DSS is defined as the time from treatment start to death due to disease or last followup. Participants who die from other causes will be censored.
Time frame: Up to 36 months
Number of Participants With Treatment Discontinuation Due to Toxicity
Toxicity grading will be performed in accordance with NCI CTCAE, version 4.0.
Time frame: 48 weeks
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