Protocol Index	

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RESEARCH PRO00020780 SINGH INCMGA00012	

Types:      Research Oncology Treatment
Synonyms:  MSI-H, ENDOMETRIAL CANCER, DMMR, PRO20780, 20780, MGA012

Screening (Day -28 to Day -1)	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Obtain Medical History
		  	RESEARCH - HEIGHT AND WEIGHT	Interval: --	Occurrences: --		  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Resting BP, RR, HR, Temp
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Physician to perform full physical exam
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate approximately 1 minute apart
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Review of concomitant medications
			Procedures
  	BIOPSY	Interval: --	Occurrences: --	Comments:	Biopsy specimen to determine MSI-H or dMMR status - Obtain formalin-fixed, paraffin embedded biopsy specimen to send to central lab
			Imaging
☑	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Disease assessment by RESIST and irRECIST - CT/MRI chest abdomen and pelvis
		☑	CT CHEST WO CONTRAST ABDOMEN WO CONTRAST PELVIS WO CONTRAST	Interval: --	Occurrences: --	Comments:	Disease assessment by RESIST and irRECIST - CT/MRI chest abdomen and pelvis
		☑	MRI CHEST W CONTRAST	Interval: --	Occurrences: --	Comments:	Disease assessment by RESIST and irRECIST - CT/MRI chest abdomen and pelvis
		☑	MRI CHEST WO CONTRAST	Interval: --	Occurrences: --	Comments:	Disease assessment by RESIST and irRECIST - CT/MRI chest abdomen and pelvis
		☑	ZZZABDOMEN W CONTRAST	Interval: --	Occurrences: --	Comments:	Disease assessment by RESIST and irRECIST - CT/MRI chest abdomen and pelvis
		☑	MRI ABDOMEN WO CONTRAST	Interval: --	Occurrences: --	Comments:	Disease assessment by RESIST and irRECIST - CT/MRI chest abdomen and pelvis
		☑	MRI PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Disease assessment by RESIST and irRECIST - CT/MRI chest abdomen and pelvis
		☑	MRI PELVIS WO CONTRAST	Interval: --	Occurrences: --	Comments:	Disease assessment by RESIST and irRECIST - CT/MRI chest abdomen and pelvis
		☑	CT HEAD W CONTRAST	Interval: --	Occurrences: --	Comments:	CT/MRI brain -On all patients who have previous history of CNS mets or as clinically indicated
		☑	CT HEAD WO CONTRAST	Interval: --	Occurrences: --	Comments:	CT/MRI brain - On all patients who have previous history of CNS mets or as clinically indicated
		☑	MRI BRAIN W CONTRAST	Interval: --	Occurrences: --	Comments:	CT/MRI brain - On all patients who have previous history of CNS mets or as clinically indicated
		☑	MRI BRAIN WO CONTRAST	Interval: --	Occurrences: --	Comments:	CT/MRI brain - On all patients who have previous history of CNS mets or as clinically indicated
			Labs
☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		☑	AMYLASE LEVEL	Interval: --	Occurrences: --		☑	LIPASE LEVEL	Interval: --	Occurrences: --		☑	URIC ACID LEVEL	Interval: --	Occurrences: --		☑	CANCER ANTIGEN 125	Interval: --	Occurrences: --		☑	TSH AND FREE T4	Interval: --	Occurrences: --		☑	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		☑	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --		☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Serum or urine pregnancy test for women of child-bearing potential
		☑	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	Serum or urine pregnancy test for women of child-bearing potential
		☑	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	Serum or urine pregnancy test for women of child-bearing potential
					
Cycle 1	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 5	Interval: --	Occurrences: --			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	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.			Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	Platelet count GREATER than OR EQUAL to 100 × 103/uL without transfusion within 28 days prior to the initiation of study drug
		  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	Absolute neutrophil count GREATER than OR EQUAL to 1.5 × 103/uL in the absence of any growth factor support within 28 days prior to the initiation of study drug
		  	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	o ALT/AST LESS than OR EQUAL to 3.0 × ULN
o For patients with hepatic metastases, ALT and AST LESS than OR EQUAL to 5 × ULN
		  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	o Total bilirubin LESS than OR EQUAL to 1.5 × ULN
o Except patients with Gilbert's syndrome, they may enroll if the conjugated bilirubin is within normal limits
		  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	Creatinine LESS than 2 mg/dL, or a calculated or measured creatinine clearance GREATER than 50 mL/min
		  	TREATMENT CONDITIONS 13	Interval: --	Occurrences: --	Comments:	Females of childbearing potential: negative urine or serum pregnancy test within 72 hours prior to initiation of study drug
			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	All assessments to be completed prior to study treatment administration unless otherwise specified
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Physician to perform symptom directed physical exam
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Resting BP, RR, HR, Temp - to be collected up to 15 mins prior to study drug administration
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate approximately 1 minute apart
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Review of concomitant medications
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Adverse event assessment
			Labs
☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		☑	AMYLASE LEVEL	Interval: --	Occurrences: --		☑	LIPASE LEVEL	Interval: --	Occurrences: --		☑	URIC ACID LEVEL	Interval: --	Occurrences: --		☑	CANCER ANTIGEN 125	Interval: --	Occurrences: --		☑	TSH AND FREE T4	Interval: --	Occurrences: --		☑	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		☑	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --		☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Serum or urine pregnancy test for women of child-bearing potential
		☑	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	Serum or urine pregnancy test for women of child-bearing potential
		☑	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	Serum or urine pregnancy test for women of child-bearing potential
			Pharmacodynamic Assessments
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Pre-Medications
  	acetaminophen (TYLENOL) tablet 500 mg	Dose: 500 mg	Route: oral	once for 1 dose	Start: S				  	diphenhydrAMINE (BENADRYL) tablet 50 mg	Dose: 50 mg	Route: oral	once for 1 dose	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	INV-INCMGA00012 in sodium chloride 0.9% IVPB	Dose: --	Route: intravenous	once over 60 Minutes for 1 dose	Start: S	End: S		Instructions:	Infusion time may be extended to 75 minutes to infuse the full dose.  Infuse through a 0.2 micron inline filter.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-INCMGA00012 250 MG INTRAVENOUS SOLN (INCMGA00012-101/PRO00020780/SINGH)	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	 	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once PRN	Start: S				  	acetaminophen (TYLENOL) tablet 500 mg	Dose: 500 mg	Route: oral	once PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	once PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	once PRN	Start: S					Pharmacodynamic Assessments
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Perform at END of infusion and 6 hours post infusion
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Ttriplicate approximately 1 minute apart) - Perform at END of infusion
		  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Resting BP, RR, HR, Temp - Perform at END of infusion and 1 hour post infusion
			Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			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.				Day 2	Perform every 1 day x1		Pharmacodynamic Assessments
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --				Day 4	Perform every 1 day x1		Pharmacodynamic Assessments
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --				Day 8	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Review of concomitant medications
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Adverse event assessment
		  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Resting BP, RR, HR, Temp
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --		  	URIC ACID LEVEL	Interval: --	Occurrences: --		  	TSH AND FREE T4	Interval: --	Occurrences: --			Pharmacodynamic Assessments
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --				Day 15	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Review of concomitant medications
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Adverse event assessment
		  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Resting BP, RR, HR, Temp
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate approximately 1 minute apart) - to be collected +/- 10 mins from PK sample
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --		  	URIC ACID LEVEL	Interval: --	Occurrences: --		  	TSH AND FREE T4	Interval: --	Occurrences: --			Pharmacodynamic Assessments
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --					
Cycle 2	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 5	Interval: --	Occurrences: --			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	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.			Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	Platelet count GREATER than OR EQUAL to 100 × 103/uL without transfusion within 28 days prior to the initiation of study drug
		  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	Absolute neutrophil count GREATER than OR EQUAL to 1.5 × 103/uL in the absence of any growth factor support within 28 days prior to the initiation of study drug
		  	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	o ALT/AST LESS than OR EQUAL to 3.0 × ULN
o For patients with hepatic metastases, ALT and AST LESS than OR EQUAL to 5 × ULN
		  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	o Total bilirubin LESS than OR EQUAL to 1.5 × ULN
o Except patients with Gilbert's syndrome, they may enroll if the conjugated bilirubin is within normal limits
		  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	Creatinine LESS than 2 mg/dL, or a calculated or measured creatinine clearance GREATER than 50 mL/min
		  	TREATMENT CONDITIONS 13	Interval: --	Occurrences: --	Comments:	Females of childbearing potential: negative urine or serum pregnancy test within 72 hours prior to initiation of study drug
			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	All assessments to be completed prior to study treatment administration unless otherwise specified
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Physician to perform symptom directed physical exam
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Resting BP, RR, HR, Temp - to be collected up to 15 mins prior to study drug administration
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate approximately 1 minute apart
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Review of concomitant medications
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Adverse event assessment
			Labs
☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		☑	AMYLASE LEVEL	Interval: --	Occurrences: --		☑	LIPASE LEVEL	Interval: --	Occurrences: --		☑	URIC ACID LEVEL	Interval: --	Occurrences: --		☑	CANCER ANTIGEN 125	Interval: --	Occurrences: --		☑	TSH AND FREE T4	Interval: --	Occurrences: --		☑	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		☑	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --		☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Serum or urine pregnancy test for women of child-bearing potential
		☑	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	Serum or urine pregnancy test for women of child-bearing potential
		☑	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	Serum or urine pregnancy test for women of child-bearing potential
			Pharmacodynamic Assessments
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Pre-Medications
  	acetaminophen (TYLENOL) tablet 500 mg	Dose: 500 mg	Route: oral	once for 1 dose	Start: S				  	diphenhydrAMINE (BENADRYL) tablet 50 mg	Dose: 50 mg	Route: oral	once for 1 dose	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	INV-INCMGA00012 in sodium chloride 0.9% IVPB	Dose: --	Route: intravenous	once over 60 Minutes for 1 dose	Start: S	End: S		Instructions:	Infusion time may be extended to 75 minutes to infuse the full dose.  Infuse through a 0.2 micron inline filter.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-INCMGA00012 250 MG INTRAVENOUS SOLN (INCMGA00012-101/PRO00020780/SINGH)	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	 	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once PRN	Start: S				  	acetaminophen (TYLENOL) tablet 500 mg	Dose: 500 mg	Route: oral	once PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	once PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	once PRN	Start: S					Pharmacodynamic Assessments
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Perform at END of infusion
			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Resting BP, RR, HR, Temp - Perform at END of infusion
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Ensure required disease assessment scans ordered per protocol
			Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			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.					
Cycle 3	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 5	Interval: --	Occurrences: --			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	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.			Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	Platelet count GREATER than OR EQUAL to 100 × 103/uL without transfusion within 28 days prior to the initiation of study drug
		  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	Absolute neutrophil count GREATER than OR EQUAL to 1.5 × 103/uL in the absence of any growth factor support within 28 days prior to the initiation of study drug
		  	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	o ALT/AST LESS than OR EQUAL to 3.0 × ULN
o For patients with hepatic metastases, ALT and AST LESS than OR EQUAL to 5 × ULN
		  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	o Total bilirubin LESS than OR EQUAL to 1.5 × ULN
o Except patients with Gilbert's syndrome, they may enroll if the conjugated bilirubin is within normal limits
		  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	Creatinine LESS than 2 mg/dL, or a calculated or measured creatinine clearance GREATER than 50 mL/min
		  	TREATMENT CONDITIONS 13	Interval: --	Occurrences: --	Comments:	Females of childbearing potential: negative urine or serum pregnancy test within 72 hours prior to initiation of study drug
			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	All assessments to be completed prior to study treatment administration unless otherwise specified
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Physician to perform symptom directed physical exam
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Resting BP, RR, HR, Temp - to be collected up to 15 mins prior to study drug administration
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate approximately 1 minute apart
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Review of concomitant medications
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Adverse event assessment
			Labs
☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		☑	AMYLASE LEVEL	Interval: --	Occurrences: --		☑	LIPASE LEVEL	Interval: --	Occurrences: --		☑	URIC ACID LEVEL	Interval: --	Occurrences: --		☑	CANCER ANTIGEN 125	Interval: --	Occurrences: --		☑	TSH AND FREE T4	Interval: --	Occurrences: --		☑	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		☑	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --		☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Serum or urine pregnancy test for women of child-bearing potential
		☑	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	Serum or urine pregnancy test for women of child-bearing potential
		☑	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	Serum or urine pregnancy test for women of child-bearing potential
			Pharmacodynamic Assessments
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Pre-Medications
  	acetaminophen (TYLENOL) tablet 500 mg	Dose: 500 mg	Route: oral	once for 1 dose	Start: S				  	diphenhydrAMINE (BENADRYL) tablet 50 mg	Dose: 50 mg	Route: oral	once for 1 dose	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	INV-INCMGA00012 in sodium chloride 0.9% IVPB	Dose: --	Route: intravenous	once over 60 Minutes for 1 dose	Start: S	End: S		Instructions:	Infusion time may be extended to 75 minutes to infuse the full dose.  Infuse through a 0.2 micron inline filter.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-INCMGA00012 250 MG INTRAVENOUS SOLN (INCMGA00012-101/PRO00020780/SINGH)	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	 	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once PRN	Start: S				  	acetaminophen (TYLENOL) tablet 500 mg	Dose: 500 mg	Route: oral	once PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	once PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	once PRN	Start: S					Pharmacodynamic Assessments
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Perform at END of infusion
			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Resting BP, RR, HR, Temp - Perform at END of infusion
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Ensure required disease assessment scans ordered per protocol
			Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			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.					
Cycle 4	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 5	Interval: --	Occurrences: --			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	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.			Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	Platelet count GREATER than OR EQUAL to 100 × 103/uL without transfusion within 28 days prior to the initiation of study drug
		  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	Absolute neutrophil count GREATER than OR EQUAL to 1.5 × 103/uL in the absence of any growth factor support within 28 days prior to the initiation of study drug
		  	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	o ALT/AST LESS than OR EQUAL to 3.0 × ULN
o For patients with hepatic metastases, ALT and AST LESS than OR EQUAL to 5 × ULN
		  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	o Total bilirubin LESS than OR EQUAL to 1.5 × ULN
o Except patients with Gilbert's syndrome, they may enroll if the conjugated bilirubin is within normal limits
		  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	Creatinine LESS than 2 mg/dL, or a calculated or measured creatinine clearance GREATER than 50 mL/min
		  	TREATMENT CONDITIONS 13	Interval: --	Occurrences: --	Comments:	Females of childbearing potential: negative urine or serum pregnancy test within 72 hours prior to initiation of study drug
			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	All assessments to be completed prior to study treatment administration unless otherwise specified
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Physician to perform symptom directed physical exam
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Resting BP, RR, HR, Temp - to be collected up to 15 mins prior to study drug administration
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate approximately 1 minute apart
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Review of concomitant medications
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Adverse event assessment
			Labs
☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		☑	AMYLASE LEVEL	Interval: --	Occurrences: --		☑	LIPASE LEVEL	Interval: --	Occurrences: --		☑	URIC ACID LEVEL	Interval: --	Occurrences: --		☑	CANCER ANTIGEN 125	Interval: --	Occurrences: --		☑	TSH AND FREE T4	Interval: --	Occurrences: --		☑	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		☑	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --		☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Serum or urine pregnancy test for women of child-bearing potential
		☑	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	Serum or urine pregnancy test for women of child-bearing potential
		☑	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	Serum or urine pregnancy test for women of child-bearing potential
			Pharmacodynamic Assessments
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Pre-Medications
  	acetaminophen (TYLENOL) tablet 500 mg	Dose: 500 mg	Route: oral	once for 1 dose	Start: S				  	diphenhydrAMINE (BENADRYL) tablet 50 mg	Dose: 50 mg	Route: oral	once for 1 dose	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	INV-INCMGA00012 in sodium chloride 0.9% IVPB	Dose: --	Route: intravenous	once over 60 Minutes for 1 dose	Start: S	End: S		Instructions:	Infusion time may be extended to 75 minutes to infuse the full dose.  Infuse through a 0.2 micron inline filter.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-INCMGA00012 250 MG INTRAVENOUS SOLN (INCMGA00012-101/PRO00020780/SINGH)	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	 	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once PRN	Start: S				  	acetaminophen (TYLENOL) tablet 500 mg	Dose: 500 mg	Route: oral	once PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	once PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	once PRN	Start: S					Pharmacodynamic Assessments
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Perform at END of infusion
			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Resting BP, RR, HR, Temp - Perform at END of infusion
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Ensure required disease assessment scans ordered per protocol
			Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			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.					
Cycle 5	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 5	Interval: --	Occurrences: --			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	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.			Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	Platelet count GREATER than OR EQUAL to 100 × 103/uL without transfusion within 28 days prior to the initiation of study drug
		  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	Absolute neutrophil count GREATER than OR EQUAL to 1.5 × 103/uL in the absence of any growth factor support within 28 days prior to the initiation of study drug
		  	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	o ALT/AST LESS than OR EQUAL to 3.0 × ULN
o For patients with hepatic metastases, ALT and AST LESS than OR EQUAL to 5 × ULN
		  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	o Total bilirubin LESS than OR EQUAL to 1.5 × ULN
o Except patients with Gilbert's syndrome, they may enroll if the conjugated bilirubin is within normal limits
		  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	Creatinine LESS than 2 mg/dL, or a calculated or measured creatinine clearance GREATER than 50 mL/min
		  	TREATMENT CONDITIONS 13	Interval: --	Occurrences: --	Comments:	Females of childbearing potential: negative urine or serum pregnancy test within 72 hours prior to initiation of study drug
			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	All assessments to be completed prior to study treatment administration unless otherwise specified
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Physician to perform symptom directed physical exam
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Resting BP, RR, HR, Temp - to be collected up to 15 mins prior to study drug administration
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate approximately 1 minute apart
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Review of concomitant medications
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Adverse event assessment
			Labs
☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		☑	AMYLASE LEVEL	Interval: --	Occurrences: --		☑	LIPASE LEVEL	Interval: --	Occurrences: --		☑	URIC ACID LEVEL	Interval: --	Occurrences: --		☑	CANCER ANTIGEN 125	Interval: --	Occurrences: --		☑	TSH AND FREE T4	Interval: --	Occurrences: --		☑	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		☑	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --		☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Serum or urine pregnancy test for women of child-bearing potential
		☑	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	Serum or urine pregnancy test for women of child-bearing potential
		☑	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	Serum or urine pregnancy test for women of child-bearing potential
			Pharmacodynamic Assessments
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Pre-Medications
  	acetaminophen (TYLENOL) tablet 500 mg	Dose: 500 mg	Route: oral	once for 1 dose	Start: S				  	diphenhydrAMINE (BENADRYL) tablet 50 mg	Dose: 50 mg	Route: oral	once for 1 dose	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S					Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once PRN	Start: S				  	acetaminophen (TYLENOL) tablet 500 mg	Dose: 500 mg	Route: oral	once PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	once PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	once PRN	Start: S					Pharmacodynamic Assessments
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Perform at END of infusion
			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Resting BP, RR, HR, Temp - Perform at END of infusion
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Ensure required disease assessment scans ordered per protocol
			Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			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.					
Cycle 6	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 5	Interval: --	Occurrences: --			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	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.			Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	Platelet count GREATER than OR EQUAL to 100 × 103/uL without transfusion within 28 days prior to the initiation of study drug
		  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	Absolute neutrophil count GREATER than OR EQUAL to 1.5 × 103/uL in the absence of any growth factor support within 28 days prior to the initiation of study drug
		  	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	o ALT/AST LESS than OR EQUAL to 3.0 × ULN
o For patients with hepatic metastases, ALT and AST LESS than OR EQUAL to 5 × ULN
		  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	o Total bilirubin LESS than OR EQUAL to 1.5 × ULN
o Except patients with Gilbert's syndrome, they may enroll if the conjugated bilirubin is within normal limits
		  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	Creatinine LESS than 2 mg/dL, or a calculated or measured creatinine clearance GREATER than 50 mL/min
		  	TREATMENT CONDITIONS 13	Interval: --	Occurrences: --	Comments:	Females of childbearing potential: negative urine or serum pregnancy test within 72 hours prior to initiation of study drug
			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	All assessments to be completed prior to study treatment administration unless otherwise specified
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Physician to perform symptom directed physical exam
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Resting BP, RR, HR, Temp - to be collected up to 15 mins prior to study drug administration
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate approximately 1 minute apart
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Review of concomitant medications
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Adverse event assessment
			Labs
☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		☑	AMYLASE LEVEL	Interval: --	Occurrences: --		☑	LIPASE LEVEL	Interval: --	Occurrences: --		☑	URIC ACID LEVEL	Interval: --	Occurrences: --		☑	CANCER ANTIGEN 125	Interval: --	Occurrences: --		☑	TSH AND FREE T4	Interval: --	Occurrences: --		☑	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		☑	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --		☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Serum or urine pregnancy test for women of child-bearing potential
		☑	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	Serum or urine pregnancy test for women of child-bearing potential
		☑	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	Serum or urine pregnancy test for women of child-bearing potential
			Pharmacodynamic Assessments
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Pre-Medications
  	acetaminophen (TYLENOL) tablet 500 mg	Dose: 500 mg	Route: oral	once for 1 dose	Start: S				  	diphenhydrAMINE (BENADRYL) tablet 50 mg	Dose: 50 mg	Route: oral	once for 1 dose	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S					Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once PRN	Start: S				  	acetaminophen (TYLENOL) tablet 500 mg	Dose: 500 mg	Route: oral	once PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	once PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	once PRN	Start: S					Pharmacodynamic Assessments
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Perform at END of infusion
			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Resting BP, RR, HR, Temp - Perform at END of infusion
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Ensure required disease assessment scans ordered per protocol
			Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			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.					
Cycle 7	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 5	Interval: --	Occurrences: --			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	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.			Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	Platelet count GREATER than OR EQUAL to 100 × 103/uL without transfusion within 28 days prior to the initiation of study drug
		  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	Absolute neutrophil count GREATER than OR EQUAL to 1.5 × 103/uL in the absence of any growth factor support within 28 days prior to the initiation of study drug
		  	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	o ALT/AST LESS than OR EQUAL to 3.0 × ULN
o For patients with hepatic metastases, ALT and AST LESS than OR EQUAL to 5 × ULN
		  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	o Total bilirubin LESS than OR EQUAL to 1.5 × ULN
o Except patients with Gilbert's syndrome, they may enroll if the conjugated bilirubin is within normal limits
		  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	Creatinine LESS than 2 mg/dL, or a calculated or measured creatinine clearance GREATER than 50 mL/min
		  	TREATMENT CONDITIONS 13	Interval: --	Occurrences: --	Comments:	Females of childbearing potential: negative urine or serum pregnancy test within 72 hours prior to initiation of study drug
			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	All assessments to be completed prior to study treatment administration unless otherwise specified
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Physician to perform symptom directed physical exam
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Resting BP, RR, HR, Temp - to be collected up to 15 mins prior to study drug administration
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate approximately 1 minute apart
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Review of concomitant medications
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Adverse event assessment
			Labs
☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		☑	AMYLASE LEVEL	Interval: --	Occurrences: --		☑	LIPASE LEVEL	Interval: --	Occurrences: --		☑	URIC ACID LEVEL	Interval: --	Occurrences: --		☑	CANCER ANTIGEN 125	Interval: --	Occurrences: --		☑	TSH AND FREE T4	Interval: --	Occurrences: --		☑	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		☑	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --		☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Serum or urine pregnancy test for women of child-bearing potential
		☑	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	Serum or urine pregnancy test for women of child-bearing potential
		☑	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	Serum or urine pregnancy test for women of child-bearing potential
			Pharmacodynamic Assessments
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Pre-Medications
  	acetaminophen (TYLENOL) tablet 500 mg	Dose: 500 mg	Route: oral	once for 1 dose	Start: S				  	diphenhydrAMINE (BENADRYL) tablet 50 mg	Dose: 50 mg	Route: oral	once for 1 dose	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S					Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once PRN	Start: S				  	acetaminophen (TYLENOL) tablet 500 mg	Dose: 500 mg	Route: oral	once PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	once PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	once PRN	Start: S					Pharmacodynamic Assessments
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Perform at END of infusion
			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Resting BP, RR, HR, Temp - Perform at END of infusion
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Ensure required disease assessment scans ordered per protocol
			Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			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.					
Cycle 8	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 5	Interval: --	Occurrences: --			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	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.			Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	Platelet count GREATER than OR EQUAL to 100 × 103/uL without transfusion within 28 days prior to the initiation of study drug
		  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	Absolute neutrophil count GREATER than OR EQUAL to 1.5 × 103/uL in the absence of any growth factor support within 28 days prior to the initiation of study drug
		  	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	o ALT/AST LESS than OR EQUAL to 3.0 × ULN
o For patients with hepatic metastases, ALT and AST LESS than OR EQUAL to 5 × ULN
		  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	o Total bilirubin LESS than OR EQUAL to 1.5 × ULN
o Except patients with Gilbert's syndrome, they may enroll if the conjugated bilirubin is within normal limits
		  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	Creatinine LESS than 2 mg/dL, or a calculated or measured creatinine clearance GREATER than 50 mL/min
		  	TREATMENT CONDITIONS 13	Interval: --	Occurrences: --	Comments:	Females of childbearing potential: negative urine or serum pregnancy test within 72 hours prior to initiation of study drug
			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	All assessments to be completed prior to study treatment administration unless otherwise specified
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Physician to perform symptom directed physical exam
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Resting BP, RR, HR, Temp - to be collected up to 15 mins prior to study drug administration
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate approximately 1 minute apart
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Review of concomitant medications
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Adverse event assessment
			Labs
☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		☑	AMYLASE LEVEL	Interval: --	Occurrences: --		☑	LIPASE LEVEL	Interval: --	Occurrences: --		☑	URIC ACID LEVEL	Interval: --	Occurrences: --		☑	CANCER ANTIGEN 125	Interval: --	Occurrences: --		☑	TSH AND FREE T4	Interval: --	Occurrences: --		☑	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		☑	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --		☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Serum or urine pregnancy test for women of child-bearing potential
		☑	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	Serum or urine pregnancy test for women of child-bearing potential
		☑	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	Serum or urine pregnancy test for women of child-bearing potential
			Pharmacodynamic Assessments
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Pre-Medications
  	acetaminophen (TYLENOL) tablet 500 mg	Dose: 500 mg	Route: oral	once for 1 dose	Start: S				  	diphenhydrAMINE (BENADRYL) tablet 50 mg	Dose: 50 mg	Route: oral	once for 1 dose	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S					Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once PRN	Start: S				  	acetaminophen (TYLENOL) tablet 500 mg	Dose: 500 mg	Route: oral	once PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	once PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	once PRN	Start: S					Pharmacodynamic Assessments
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Perform at END of infusion
			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Resting BP, RR, HR, Temp - Perform at END of infusion
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Ensure required disease assessment scans ordered per protocol
			Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			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.					
End of Treatment	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Physician to perform full physical exam
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Resting BP, RR, HR, Temp
		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Ttriplicate approximately 1 minute apart - Perform at any time point but + 10 mins from EOTV PK
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Review of concomitant medications
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Adverse event assessment
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Ensure required disease assessment scans ordered per protocol
			Labs
☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		☑	AMYLASE LEVEL	Interval: --	Occurrences: --		☑	LIPASE LEVEL	Interval: --	Occurrences: --		☑	URIC ACID LEVEL	Interval: --	Occurrences: --		☑	CANCER ANTIGEN 125	Interval: --	Occurrences: --		☑	TSH AND FREE T4	Interval: --	Occurrences: --		☑	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		☑	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --		☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Serum or urine pregnancy test for women of child-bearing potential
		☑	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	Serum or urine pregnancy test for women of child-bearing potential
		☑	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	Serum or urine pregnancy test for women of child-bearing potential
			Pharmacodynamic Assessments
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --