This phase I clinical trial studies the side effects of selinexor in treating patients with melanoma that cannot be removed by surgery. Drugs used in chemotherapy, such as selinexor, may stop the growth of tumor cells, by stopping them from dividing.
Name: selinexor
Name: Correlative studies
Description: Types of toxicities, incidences and severity will be summarized by descriptive statistics such as frequencies/proportions.
Measure: Incidence of adverse events graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 Time: 28 daysDescription: Kaplan-Meier method will be used to assess the PFS.
Measure: PFS Time: From date of registration to date of first documentation of progression or symptomatic deterioration or death due to any cause or last contact, assessed up to 1 yearDescription: Markers with continuous numerical data will be analyzed using linear mixed effects models (LMEMs). Binary markers (presence vs. absence) will be summarized by proportions and the confidence intervals will be calculated. Marker changes by mutation groups in plots will be presented. To correlate the marker changes with response, mainly summary statistics and plots will be used given the potentially small subgroups.
Measure: Change in tumor markers by immunohistochemistry Time: Baseline to up to 1 yearAllocation: N/A
Single Group Assignment
There are 2 SNPs
interleukin 2) and a BRAF and/or MEK inhibitor (if tumor contains the V600E or V600K mutation) for 628 metastatic disease. --- V600E ---
interleukin 2) and a BRAF and/or MEK inhibitor (if tumor contains the V600E or V600K mutation) for 628 metastatic disease. --- V600E --- --- V600K ---