..7 1.1 Primary Objectives ............................................................................................................ ...7 1.2 Secondary Objectives .......................................................................................................... .7 2. BACKGROUND .................................................................................................................8 2.1 Study Disease(s)...................................................................................................................8 2.2 CTEP and/or CIP IND Agent(s): N/A .................................................................................8 2.3 Other Agents ........................................................................................................................9 2.4 Rationale ..................................................................................................................... .......15 3. PATIENT SELECTION ....................................................................................................19 3.1 Eligibility Criteria ..............................................................................................................19 3.2 Exclusion Criteria ..............................................................................................................22 3.3 Inclusion of Women and Minorities ..................................................................................25 4. REGISTRATION PROCEDURES ...................................................................................25 4.1 Registration Process .......................................................................................................... .25 5. TREATMENT PLAN ........................................................................................................27 5.1 Agent Administration .........................................................................................................27 5.2 Definition of Dose-Limiting Toxicity:...............................................................................31 5.3 General Concomitant Medication an d Supportive Care Guidelines ..................................31 5.4 Duration of Therapy ...........................................................................................................33 5.5 Duration of Follow-up .......................................................................................................34 5.6 Criteria for Removal from Study .......................................................................................35 6. DOSING DELAYS/DOSE MODIFICATIONS................................................................35 6.1 Delayed Visits for Reasons Other Than Toxicity ..............................................................38 7. ADVERSE EVENTS: LIST AND REPORTING REQUIREMENTS .............................39 7.1 Comprehensive Adverse Events and Potential Risks List(s) (CAEPRs) ...........................39 7.2 Adverse Event Characteristics ...........................................................................................46 7.3 Expedited Adverse Event Reporting ..................................................................................46 7.4 Routine Adverse Event Reporting .....................................................................................48 7.5 Secondary Malignancy .......................................................................................................48 7.6 Second Malignancy ............................................................................................................48 8. PHARMACEUTICAL INFORMATION ..........................................................................49 8.1 CTEP IND Agent(s): N/A ..................................................................................................49 8.2 INCB024360, Inhibitor of Indoleamine 2,3- dioxygenase (IDO, NSC # 766086) .............49 8.3 MELITAC 12.1 ..................................................................................................................