32 3.1 Study Design .................................................................................................................. 32 3.1.1 Dose -Limiting Toxicity .......................................................................................... 33 3.1.2 DLT Evaluation Period ........................................................................................... 33 3.1.3 Schema .................................................................................................................... 34 3.2 Drug Administration ...................................................................................................... 35 3.3 Study Calendar ............................................................................................................... 35 3.4 Criteria for Removal from Protocol Therapy and Off- Study Criteria ............................ 36 3.4.1 Criteria for Removal from Protocol Therapy .......................................................... 37 3.4.2 Off-Study Criteria ................................................................................................... 37 3.4.3 Off-Study Procedure ............................................................................................... 37 4 CONCOMITANT MEDICATIONS/MEASURES .............................................................. 37 5 BIOSPECIMEN COLLECTION .......................................................................................... 38 5.1 Correlative Studies for Research/Pharmacokinetic Studies ........................................... 38 5.1.1 Parameters of Immune Activation .......................................................................... 38 5.1.2 Brachyury expression in tissue samples ................................................................. 39 5.2 Samp le Storage, Tracking, and Disposition ...................................................................