Protocol Index	

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OP RESEARCH PRO00035735 ANHL1931 SCREENING PINGALI	

Types:      Research Oncology Treatment
Synonyms:  

Cycle 1	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Physical exam to be done within 7 days prior to enrollment
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	To be performed within 7 days prior to enrollment.
		  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --	Comments:	o Height is only required at the beginning of this cycle. If there is a GREATER than 5% change in weight, BSA will be recalculated prior to each cycle. 
o To be performed within 7 days prior to enrollment.
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Performance status to be performed within 7 days prior to enrollment.
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Adverse Events: Continuously every day, every cycle. 
To ensure compliance with these regulations/this guidance, as IND/IDE sponsor, NCI requires that AEs be submitted according to the timeframes in the AE reporting tables
assigned to the protocol, using the CTEP Adverse Event Reporting System (CTEP-AERS).
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Concomitant Medications: continuously every day, every cycle. 
Please refer to section 4.0 page 24-25 for restrictions/
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Randomization will take place only after a patient is enrolled via OPEN. The treatment will be randomly assigned based on the statistical design of the trial.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Within 7 days prior to enrollment
		  	LDH	Interval: --	Occurrences: --	Comments:	Within 7 days prior to enrollment
		  	AST (SGOT)	Interval: --	Occurrences: --	Comments:	Within 7 days prior to enrollment
		  	ALT (SGPT)	Interval: --	Occurrences: --	Comments:	Within 7 days prior to enrollment
		  	TOTAL BILIRUBIN	Interval: --	Occurrences: --	Comments:	Within 7 days prior to enrollment
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Within 7 days prior to enrollment
		  	SODIUM LEVEL	Interval: --	Occurrences: --	Comments:	Within 7 days prior to enrollment
		  	POTASSIUM LEVEL	Interval: --	Occurrences: --	Comments:	Within 7 days prior to enrollment
		  	CHLORIDE LEVEL	Interval: --	Occurrences: --	Comments:	Within 7 days prior to enrollment
		  	CALCIUM LEVEL	Interval: --	Occurrences: --	Comments:	Within 7 days prior to enrollment
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Within 7 days prior to enrollment
		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Within 7 days prior to enrollment
		  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	o Within 7 days prior to enrollment. 
o Baseline and prior to every cycle. If TSH is abnormal T3 and FT4 should be evaluated. Only for Arm B , D and F.
		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Female patients of childbearing potential require a negative pregnancy test prior to starting each cycle.
			Labs
  	HEPATITIS B SURFACE ANTIBODY	Interval: --	Occurrences: --	Comments:	Within 7 days prior to enrollment
		  	HEPATITIS B SURFACE ANTIGEN	Interval: --	Occurrences: --	Comments:	Within 7 days prior to enrollment
		  	HEPATITIS B CORE ANTIBODY TOTAL	Interval: --	Occurrences: --	Comments:	Within 7 days prior to enrollment
		  	HEPATITIS C ANTIBODY	Interval: --	Occurrences: --	Comments:	Within 7 days prior to enrollment
			Labs
  	HIV 1/2 ANTIGEN/ANTIBODY, FOURTH GENERATION, WITH REFLEXES	Interval: --	Occurrences: --			Procedures
  	FL LUMBAR PUNCTURE	Interval: --	Occurrences: --	Comments:	Within 7 days prior to enrollment. Optional at baseline only, not required.
			Labs
  	CSF CELL COUNT WITH DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Within 7 days prior to enrollment. Optional at baseline only, not required.
			Procedures
  	BIOPSY BONE MARROW	Interval: --	Occurrences: --	Comments:	Unilateral bone marrow biopsy and aspirate to be performed within 7 days prior to enrollment. Baseline and ater cycle 2 and 6 if involved at diagnosis. Optional, not required
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	o Within 21 days prior to enrollment. 
o Only performed if the following circumstances: at baseline if PET/CT not feasible; after cycle 2 if PET/CT not performed.
		  	PET CT WHOLE BODY	Interval: --	Occurrences: --	Comments:	o Within 21 days prior to enrollment. 	
o Required at baseline and after Cycle 6. Optional PET/CT after cycle 2. Optional PET/CT after cycle 4 in patients for whom imaging after cycle 2 demonstrates increase in SUV from baseline without increase in tumor size by CT measurements.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Echocardiogram and ECG as clinically indicated per institutional guidelines. Place order if needed.