 Statistics: Descriptive statistics will be used to summarize subject baseline characteristics, treatment administrationcompliance, etc. Data will also be displayed graphically, when appropriate. An accounting of all subjects enrolled will be summarized. The number of subjects discontinuing from the study and the reasons for discontinuation will be tabulated. Subjects who did not meet eligibility criteria will be described. Demographic and baseline characteristics such as subject age, sex, race, height, weight, ECOG performance status, malignancy history, and medical history will be summarized. Wilcoxon signed rank test will be used to compare changes in biomarker expression. 