Protocol Index	

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RESEARCH CTL H-40378 (TACTOPS)	

Types:      Research Oncology Treatment
Synonyms:  TUMOR ASSOCIATED ANTIGEN , TAA, PANCREATIC CANCER , CATHERINE ROBERTSON , 832-824-4594

Infusion 1	Repeat 1 time	Cycle length: 5 days	Pre-Study	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --	Comments:	Start peripheral IV, if no central line. Use 3-way stopcock and tubing.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	(Include breath sounds)
		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	RESEARCH - HEIGHT AND WEIGHT	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	CANCER ANTIGEN 19-9	Interval: --	Occurrences: --	Comments:	CA 19-9 or CEA or CA-125
		  	CARCINOEMBRYONIC ANTIGEN (CEA)	Interval: --	Occurrences: --	Comments:	CA 19-9 or CEA or CA-125
		  	CANCER ANTIGEN 125	Interval: --	Occurrences: --	Comments:	CA 19-9 or CEA or CA-125
		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For female patients.
		  	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	For female patients.
			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Research Coordinator:  Please schedule Required Studies.
				Day 0	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 8	Interval: --	Occurrences: --			Nursing Orders
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --	Comments:	Start peripheral IV, if no central line. Use 3-way stopcock and tubing.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	(Include breath sounds) Pre-Infusion, during infusion, post infusion, q 30 minutes and at 1 hour post infusion.
		  	RESEARCH -  PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	Pre-infusion, during infusion, post infusion, q 30 minutes and continue to monitor for 30 minutes Post-Infusion.
		  	RESEARCH - HEIGHT AND WEIGHT	Interval: --	Occurrences: --		  	RESEARCH - SUPPLIES/KIT TO BEDSIDE	Interval: --	Occurrences: --	Comments:	Must be at bedside prior to infusion: Oxygen and suction set up, sterile gloves, normal saline flushes, alcohol preps, and syringes with needles.
		  	RESEARCH - ASSESS	Interval: --	Occurrences: --	Comments:	Patient for immediate reactions: 1) Allergic reactions (anaphylaxis) 2) Decreased oxygenation (due to migration of lymphocytes to lungs).
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	CANCER ANTIGEN 19-9	Interval: --	Occurrences: --	Comments:	CA 19-9 or CEA or CA-125
		  	CARCINOEMBRYONIC ANTIGEN (CEA)	Interval: --	Occurrences: --	Comments:	CA 19-9 or CEA or CA-125
		  	CANCER ANTIGEN 125	Interval: --	Occurrences: --	Comments:	CA 19-9 or CEA or CA-125
		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For female patients.
		  	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	For female patients.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Hydration
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open			Pre-Medications
  	acetaminophen (TYLENOL) tablet 10 mg/kg (Treatment Plan)	Dose: 10 mg/kg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Please order as soon as labs are sent.. Give 30 minutes prior to product administration.		  	diphenhydrAMINE (BENADRYL) injection 0.5-1 mg/kg (Treatment Plan)	Dose: 0.5-1 mg/kg	Route: intravenous	once for 1 dose			Offset: 0 Hours	Instructions:	Please order as soon as labs are sent.. Give 30 minutes prior to product administration.			Nursing Orders
  	ONC NURSING COMMUNICATION 100	Interval: --	Occurrences: --	Comments:	Cells to be administered by physician (generally by syringe injection with 0.9% Normal Saline flush)

Verify cell dose and patient information on Component Infusion Form. Record infusion start and stop time on form and place in patient's medical record.

Clinic nurse to remain at bedside during the entire infusion

Ensure informed consent is obtained
			Emergency Medications
  	TRANSFUSION REACTION EVALUATION	Interval: --	Occurrences: --	Comments:	Emergency Medications: Anaphylactic precautions: Keep medications at the bedside to administer per physician's orders.
		  	diphenhydrAMINE (BENADRYL) injection	Dose: --	Route: intravenous	once PRN	Start: S			Instructions:	Keep at the bedside to administer per physician's orders.
(Max dose 50 mg)		  	hydrocortisone sodium succinate (Solu-CORTEF) injection	Dose: --	Route: intravenous	once PRN	Start: S			Instructions:	Keep at the bedside to administer per physician's orders. 
(Max dose 250 mg)		  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.5-1 mg	Dose: 0.5-1 mL	Route: intravenous	once PRN	Start: S			Instructions:	Keep at the bedside to administer per physician's orders.
(Dose range: 0.5 to 1 mL)			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.