Protocol Index	

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RESEARCH PRO00011685 NIRAVATH L-NMMA PLUS DOCETAXEL	

Types:      Research Oncology Treatment, ONCOLOGY SUPPORTIVE CARE
Synonyms:  PRO00011685, L-NMMA, DOCETAXEL, TRIPLE NEGATIVE BREAST CANCER, BREAST, NIRAVATH, LNMMA

Screening	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Vitals
  	VITAL SIGNS - T/P/R/BP PER UNIT PROTOCOL	Interval: --	Occurrences: --	Comments:	Obtain Height with first visit; Weight with every visit. 
Monitor BP, HR, Temp, RR with Every visit.
			Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Research Coordinator: Please schedule 12 Lead ECG, Echocardiogram or MUGA, CT or MRI of Chest, Abdomen, Pelvis with and without Oral and IV Contrast.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	URIC ACID LEVEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --					
Cycle 1	Repeat 1 time	Cycle length: 21 days	Day 0	Perform every 1 day x1		Vitals
  	VITAL SIGNS - T/P/R/BP PER UNIT PROTOCOL	Interval: --	Occurrences: --	Comments:	Obtain Height with first visit; Weight with every visit. 
Monitor BP, HR, Temp, RR with Every visit.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	URIC ACID LEVEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --			Pre-Medications
  	INV amlodipine 10 mg tablet, PRO00011685/Niravath, 10 mg	Dose: --	Route: oral	daily	Dispense: --	Refills: --	Start: S	End: S+6		Instructions:	Start taking 24 hours PRIOR to the Day 1 L-NMMA Infusion.  Bring to infusion appointment.  Take at least 30 minutes PRIOR to L-NMMA Infusion on Days 1 through 5			Pre-Medications
  	dexamethasone (DECADRON) 4 MG tablet	Dose: 8 mg	Route: oral	daily	Dispense: 6 tablet	Refills: --	Start: S	End: S+3		Instructions:	Take the day before, the day of, and the day after DOCEtaxel infusion.				Prior to each Cycle	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 8	Interval: --	Occurrences: --			Vitals
  	VITAL SIGNS - T/P/R/BP PER UNIT PROTOCOL	Interval: --	Occurrences: --	Comments:	Obtain Height with first visit; Weight with every visit. 
Monitor BP, HR, Temp, RR with Every visit.
			Pre-Medications
  	INV amlodipine 10 mg tablet (PRO00011685/Niravath)	Dose: --	Route: oral	daily for 6 doses			Offset: 0 Hours	Instructions:	Take one tablet by mouth at least 30 minutes PRIOR to L-NMMA infusion, as instructed by the research staff. To be started 24 hours prior to L-NMMA infusion and then daily on days of L-NMMA infusion. Hold for SBP less than 100 mmHg.			Vitals
  	VITAL SIGNS - T/P/R/BP PER UNIT PROTOCOL	Interval: --	Occurrences: --	Comments:	Blood Pressure must be monitored every 30 minutes during L-NMMA Infusion.  Patient should also be monitored for 30 minutes post-infusion

If Systolic BP GREATER than 180 mm Hg, STOP Infusion.  Recheck in 30 minutes.
If Systolic BP DECREASES to LESS than 160 mm Hg, Restart Infusion.  
If Still GREATER than 160 mm Hg, Recheck in 15-30 minutes.
If Systolic BP GREATER than 160 mm Hg a Second Time, Discontinue Infusion and Contact MD and Research Coordinator.
If Infusion is Restarted and Systolic BP Increases to GREATER than 180 mm Hg a second time, Discontinue Infusion and Contact MD and Research Coordinator.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Biologicals
  	INV L-NMMA (PRO00011685/Niravath) IVPB in sodium chloride 0.9%	Dose: --	Route: intravenous	once over 2 Hours for 1 dose			Offset: 0 Hours	Instructions:	L-NMMA dosage will de-escalate/escalate based on the CRM. Contains active study drug L-NMMA in NS, total volume 100 mL. Prepared bag is stable for 4 hours when refrigerated. Infuse intravenously over 2 hours. Caution: Limited by Federal (USA) Law to Investigational Drug.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV L-NMMA (PRO00011685/NIRAVATH) VIAL	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes				Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Pre-Medications
  	ondansetron (ZOFRAN) IV 16 mg	Dose: 16 mg	Route: intravenous	once for 1 dose			Offset: 2 Hours			Antiemetics
  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 2.25 Hours			Chemotherapy
  	DOCEtaxel (TAXOTERE) 75 mg/m2 in sodium chloride (NON-PVC) 0.9 % 250 mL chemo IVPB	Dose: 75 mg/m2	Route: intravenous	once over 60 Minutes for 1 dose			Offset: 2.75 Hours	Instructions:	Administer through non-DEHP tubing; Use within 4 hours of preparation; Protect from light. Administer over 1 hour (+/- 10 minutes).	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	DOCETAXEL 80 MG/4 ML (20 MG/ML) INTRAVENOUS SOLUTION	Medications	75 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % IV SOLP (EXCEL;NON-PVC)	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) IV SOLP (EXCEL; NON-PVC)	QS Base	250 mL	No	Yes				Emergency Medications
  	ONC NURSING COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	Notify covering provider of reaction and symptoms.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once PRN				Instructions:	May repeat once after 15 minutes if needed. If given IV, administer 25 mg over 1 minute or 50 mg over 2 minutes.		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once PRN				Instructions:	If given IV, administer 25 mg over 1 minute or 50 mg over 2 minutes.		  	dexAMETHasone (DECADRON) IV 10 mg	Dose: 10 mg	Route: intravenous	once PRN	Start: S			Instructions:	Administer over 1 minute.		  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once PRN	Start: S					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.
				Day 2	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 5	Interval: --	Occurrences: --			Vitals
  	VITAL SIGNS - T/P/R/BP PER UNIT PROTOCOL	Interval: --	Occurrences: --	Comments:	Obtain Height with first visit; Weight with every visit. 
Monitor BP, HR, Temp, RR with Every visit.
			Pre-Medications
  	INV amlodipine 10 mg tablet (PRO00011685/Niravath)	Dose: --	Route: oral	daily for 6 doses			Offset: 0 Hours	Instructions:	Take one tablet by mouth at least 30 minutes PRIOR to L-NMMA infusion, as instructed by the research staff. To be started 24 hours prior to L-NMMA infusion and then daily on days of L-NMMA infusion. Hold for SBP less than 100 mmHg.			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Vitals
  	VITAL SIGNS - T/P/R/BP PER UNIT PROTOCOL	Interval: --	Occurrences: --	Comments:	Blood Pressure must be monitored every 30 minutes during L-NMMA Infusion.  Patient should also be monitored for 30 minutes post-infusion

If Systolic BP GREATER than 180 mm Hg, STOP Infusion.  Recheck in 30 minutes.
If Systolic BP DECREASES to LESS than 160 mm Hg, Restart Infusion.  
If Still GREATER than 160 mm Hg, Recheck in 15-30 minutes.
If Systolic BP GREATER than 160 mm Hg a Second Time, Discontinue Infusion and Contact MD and Research Coordinator.
If Infusion is Restarted and Systolic BP Increases to GREATER than 180 mm Hg a second time, Discontinue Infusion and Contact MD and Research Coordinator.
			Biologicals
  	INV L-NMMA (PRO00011685/Niravath) IVPB in sodium chloride 0.9%	Dose: --	Route: intravenous	once over 2 Hours for 1 dose			Offset: 0 Hours	Instructions:	L-NMMA dosage will de-escalate/escalate based on the CRM. Contains active study drug L-NMMA in NS, total volume 100 mL. Prepared bag is stable for 4 hours when refrigerated. Infuse intravenously over 2 hours. Caution: Limited by Federal (USA) Law to Investigational Drug.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV L-NMMA (PRO00011685/NIRAVATH) VIAL	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes				Emergency Medications
  	ONC NURSING COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	Notify covering provider of reaction and symptoms.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once PRN				Instructions:	May repeat once after 15 minutes if needed. If given IV, administer 25 mg over 1 minute or 50 mg over 2 minutes.		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once PRN				Instructions:	If given IV, administer 25 mg over 1 minute or 50 mg over 2 minutes.		  	dexAMETHasone (DECADRON) IV 10 mg	Dose: 10 mg	Route: intravenous	once PRN	Start: S			Instructions:	Administer over 1 minute.		  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once PRN	Start: S					Supportive Care
  	pegfilgrastim (NEULASTA) on-body injection kit 6 mg	Dose: 6 mg	Route: subcutaneous	once for 1 dose				Instructions:	To inject at least 24 hours after chemotherapy complete.			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.
				Day 3	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 5	Interval: --	Occurrences: --			Vitals
  	VITAL SIGNS - T/P/R/BP PER UNIT PROTOCOL	Interval: --	Occurrences: --	Comments:	Obtain Height with first visit; Weight with every visit. 
Monitor BP, HR, Temp, RR with Every visit.
			Pre-Medications
  	INV amlodipine 10 mg tablet (PRO00011685/Niravath)	Dose: --	Route: oral	daily for 6 doses			Offset: 0 Hours	Instructions:	Take one tablet by mouth at least 30 minutes PRIOR to L-NMMA infusion, as instructed by the research staff. To be started 24 hours prior to L-NMMA infusion and then daily on days of L-NMMA infusion. Hold for SBP less than 100 mmHg.			Vitals
  	VITAL SIGNS - T/P/R/BP PER UNIT PROTOCOL	Interval: --	Occurrences: --	Comments:	Blood Pressure must be monitored every 30 minutes during L-NMMA Infusion.  Patient should also be monitored for 30 minutes post-infusion

If Systolic BP GREATER than 180 mm Hg, STOP Infusion.  Recheck in 30 minutes.
If Systolic BP DECREASES to LESS than 160 mm Hg, Restart Infusion.  
If Still GREATER than 160 mm Hg, Recheck in 15-30 minutes.
If Systolic BP GREATER than 160 mm Hg a Second Time, Discontinue Infusion and Contact MD and Research Coordinator.
If Infusion is Restarted and Systolic BP Increases to GREATER than 180 mm Hg a second time, Discontinue Infusion and Contact MD and Research Coordinator.
			Biologicals
  	INV L-NMMA (PRO00011685/Niravath) IVPB in sodium chloride 0.9%	Dose: --	Route: intravenous	once over 2 Hours for 1 dose			Offset: 0 Hours	Instructions:	L-NMMA dosage will de-escalate/escalate based on the CRM. Contains active study drug L-NMMA in NS, total volume 100 mL. Prepared bag is stable for 4 hours when refrigerated. Infuse intravenously over 2 hours. Caution: Limited by Federal (USA) Law to Investigational Drug.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV L-NMMA (PRO00011685/NIRAVATH) VIAL	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes				Emergency Medications
  	ONC NURSING COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	Notify covering provider of reaction and symptoms.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once PRN				Instructions:	May repeat once after 15 minutes if needed. If given IV, administer 25 mg over 1 minute or 50 mg over 2 minutes.		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once PRN				Instructions:	If given IV, administer 25 mg over 1 minute or 50 mg over 2 minutes.		  	dexAMETHasone (DECADRON) IV 10 mg	Dose: 10 mg	Route: intravenous	once PRN	Start: S			Instructions:	Administer over 1 minute.		  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once PRN	Start: S					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.
				Day 4	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 5	Interval: --	Occurrences: --			Vitals
  	VITAL SIGNS - T/P/R/BP PER UNIT PROTOCOL	Interval: --	Occurrences: --	Comments:	Obtain Height with first visit; Weight with every visit. 
Monitor BP, HR, Temp, RR with Every visit.
			Pre-Medications
  	INV amlodipine 10 mg tablet (PRO00011685/Niravath)	Dose: --	Route: oral	daily for 6 doses			Offset: 0 Hours	Instructions:	Take one tablet by mouth at least 30 minutes PRIOR to L-NMMA infusion, as instructed by the research staff. To be started 24 hours prior to L-NMMA infusion and then daily on days of L-NMMA infusion. Hold for SBP less than 100 mmHg.			Vitals
  	VITAL SIGNS - T/P/R/BP PER UNIT PROTOCOL	Interval: --	Occurrences: --	Comments:	Blood Pressure must be monitored every 30 minutes during L-NMMA Infusion.  Patient should also be monitored for 30 minutes post-infusion

If Systolic BP GREATER than 180 mm Hg, STOP Infusion.  Recheck in 30 minutes.
If Systolic BP DECREASES to LESS than 160 mm Hg, Restart Infusion.  
If Still GREATER than 160 mm Hg, Recheck in 15-30 minutes.
If Systolic BP GREATER than 160 mm Hg a Second Time, Discontinue Infusion and Contact MD and Research Coordinator.
If Infusion is Restarted and Systolic BP Increases to GREATER than 180 mm Hg a second time, Discontinue Infusion and Contact MD and Research Coordinator.
			Biologicals
  	INV L-NMMA (PRO00011685/Niravath) IVPB in sodium chloride 0.9%	Dose: --	Route: intravenous	once over 2 Hours for 1 dose			Offset: 0 Hours	Instructions:	L-NMMA dosage will de-escalate/escalate based on the CRM. Contains active study drug L-NMMA in NS, total volume 100 mL. Prepared bag is stable for 4 hours when refrigerated. Infuse intravenously over 2 hours. Caution: Limited by Federal (USA) Law to Investigational Drug.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV L-NMMA (PRO00011685/NIRAVATH) VIAL	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes				Emergency Medications
  	ONC NURSING COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	Notify covering provider of reaction and symptoms.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once PRN				Instructions:	May repeat once after 15 minutes if needed. If given IV, administer 25 mg over 1 minute or 50 mg over 2 minutes.		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once PRN				Instructions:	If given IV, administer 25 mg over 1 minute or 50 mg over 2 minutes.		  	dexAMETHasone (DECADRON) IV 10 mg	Dose: 10 mg	Route: intravenous	once PRN	Start: S			Instructions:	Administer over 1 minute.		  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once PRN	Start: S					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.
				Day 5	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 5	Interval: --	Occurrences: --			Vitals
  	VITAL SIGNS - T/P/R/BP PER UNIT PROTOCOL	Interval: --	Occurrences: --	Comments:	Obtain Height with first visit; Weight with every visit. 
Monitor BP, HR, Temp, RR with Every visit.
			Pre-Medications
  	INV amlodipine 10 mg tablet (PRO00011685/Niravath)	Dose: --	Route: oral	daily for 6 doses			Offset: 0 Hours	Instructions:	Take one tablet by mouth at least 30 minutes PRIOR to L-NMMA infusion, as instructed by the research staff. To be started 24 hours prior to L-NMMA infusion and then daily on days of L-NMMA infusion. Hold for SBP less than 100 mmHg.			Vitals
  	VITAL SIGNS - T/P/R/BP PER UNIT PROTOCOL	Interval: --	Occurrences: --	Comments:	Blood Pressure must be monitored every 30 minutes during L-NMMA Infusion.  Patient should also be monitored for 30 minutes post-infusion

If Systolic BP GREATER than 180 mm Hg, STOP Infusion.  Recheck in 30 minutes.
If Systolic BP DECREASES to LESS than 160 mm Hg, Restart Infusion.  
If Still GREATER than 160 mm Hg, Recheck in 15-30 minutes.
If Systolic BP GREATER than 160 mm Hg a Second Time, Discontinue Infusion and Contact MD and Research Coordinator.
If Infusion is Restarted and Systolic BP Increases to GREATER than 180 mm Hg a second time, Discontinue Infusion and Contact MD and Research Coordinator.
			Biologicals
  	INV L-NMMA (PRO00011685/Niravath) IVPB in sodium chloride 0.9%	Dose: --	Route: intravenous	once over 2 Hours for 1 dose			Offset: 0 Hours	Instructions:	L-NMMA dosage will de-escalate/escalate based on the CRM. Contains active study drug L-NMMA in NS, total volume 100 mL. Prepared bag is stable for 4 hours when refrigerated. Infuse intravenously over 2 hours. Caution: Limited by Federal (USA) Law to Investigational Drug.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV L-NMMA (PRO00011685/NIRAVATH) VIAL	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes				Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Emergency Medications
  	ONC NURSING COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	Notify covering provider of reaction and symptoms.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once PRN				Instructions:	May repeat once after 15 minutes if needed. If given IV, administer 25 mg over 1 minute or 50 mg over 2 minutes.		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once PRN				Instructions:	If given IV, administer 25 mg over 1 minute or 50 mg over 2 minutes.		  	dexAMETHasone (DECADRON) IV 10 mg	Dose: 10 mg	Route: intravenous	once PRN	Start: S			Instructions:	Administer over 1 minute.		  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once PRN	Start: S					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.
					
Cycle 2	Repeat 1 time	Cycle length: 21 days	Day 0	Perform every 1 day x1		Vitals
  	VITAL SIGNS - T/P/R/BP PER UNIT PROTOCOL	Interval: --	Occurrences: --	Comments:	Obtain Height with first visit; Weight with every visit. 
Monitor BP, HR, Temp, RR with Every visit.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	URIC ACID LEVEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --			Pre-Medications
  	INV amlodipine 10 mg tablet, PRO00011685/Niravath, 10 mg	Dose: --	Route: oral	daily	Dispense: --	Refills: --	Start: S	End: S+6		Instructions:	Start taking 24 hours PRIOR to the Day 1 L-NMMA Infusion.  Bring to infusion appointment.  Take at least 30 minutes PRIOR to L-NMMA Infusion on Days 1 through 5			Pre-Medications
  	dexamethasone (DECADRON) 4 MG tablet	Dose: 8 mg	Route: oral	daily	Dispense: 6 tablet	Refills: --	Start: S	End: S+3		Instructions:	Take the day before, the day of, and the day after DOCEtaxel infusion.				Prior to each Cycle	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 8	Interval: --	Occurrences: --			Vitals
  	VITAL SIGNS - T/P/R/BP PER UNIT PROTOCOL	Interval: --	Occurrences: --	Comments:	Obtain Height with first visit; Weight with every visit. 
Monitor BP, HR, Temp, RR with Every visit.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Pre-Medications
  	INV amlodipine 10 mg tablet (PRO00011685/Niravath)	Dose: --	Route: oral	daily for 6 doses			Offset: 0 Hours	Instructions:	Take one tablet by mouth at least 30 minutes PRIOR to L-NMMA infusion, as instructed by the research staff. To be started 24 hours prior to L-NMMA infusion and then daily on days of L-NMMA infusion. Hold for SBP less than 100 mmHg.			Vitals
  	VITAL SIGNS - T/P/R/BP PER UNIT PROTOCOL	Interval: --	Occurrences: --	Comments:	Blood Pressure must be monitored every 30 minutes during L-NMMA Infusion.  Patient should also be monitored for 30 minutes post-infusion

If Systolic BP GREATER than 180 mm Hg, STOP Infusion.  Recheck in 30 minutes.
If Systolic BP DECREASES to LESS than 160 mm Hg, Restart Infusion.  
If Still GREATER than 160 mm Hg, Recheck in 15-30 minutes.
If Systolic BP GREATER than 160 mm Hg a Second Time, Discontinue Infusion and Contact MD and Research Coordinator.
If Infusion is Restarted and Systolic BP Increases to GREATER than 180 mm Hg a second time, Discontinue Infusion and Contact MD and Research Coordinator.
			Biologicals
  	INV L-NMMA (PRO00011685/Niravath) IVPB in sodium chloride 0.9%	Dose: --	Route: intravenous	once over 2 Hours for 1 dose			Offset: 0 Hours	Instructions:	L-NMMA dosage will de-escalate/escalate based on the CRM. Contains active study drug L-NMMA in NS, total volume 100 mL. Prepared bag is stable for 4 hours when refrigerated. Infuse intravenously over 2 hours. Caution: Limited by Federal (USA) Law to Investigational Drug.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV L-NMMA (PRO00011685/NIRAVATH) VIAL	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes				Pre-Medications
  	ondansetron (ZOFRAN) IV 16 mg	Dose: 16 mg	Route: intravenous	once for 1 dose			Offset: 2 Hours			Antiemetics
  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 2.25 Hours			Chemotherapy
  	DOCEtaxel (TAXOTERE) 75 mg/m2 in sodium chloride (NON-PVC) 0.9 % 250 mL chemo IVPB	Dose: 75 mg/m2	Route: intravenous	once over 60 Minutes for 1 dose			Offset: 2.75 Hours	Instructions:	Administer through non-DEHP tubing; Use within 4 hours of preparation; Protect from light. Administer over 1 hour (+/- 10 minutes).	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	DOCETAXEL 80 MG/4 ML (20 MG/ML) INTRAVENOUS SOLUTION	Medications	75 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % IV SOLP (EXCEL;NON-PVC)	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) IV SOLP (EXCEL; NON-PVC)	QS Base	250 mL	No	Yes				Emergency Medications
  	ONC NURSING COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	Notify covering provider of reaction and symptoms.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once PRN				Instructions:	May repeat once after 15 minutes if needed. If given IV, administer 25 mg over 1 minute or 50 mg over 2 minutes.		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once PRN				Instructions:	If given IV, administer 25 mg over 1 minute or 50 mg over 2 minutes.		  	dexAMETHasone (DECADRON) IV 10 mg	Dose: 10 mg	Route: intravenous	once PRN	Start: S			Instructions:	Administer over 1 minute.		  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once PRN	Start: S					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.
				Day 2	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 5	Interval: --	Occurrences: --			Vitals
  	VITAL SIGNS - T/P/R/BP PER UNIT PROTOCOL	Interval: --	Occurrences: --	Comments:	Obtain Height with first visit; Weight with every visit. 
Monitor BP, HR, Temp, RR with Every visit.
			Pre-Medications
  	INV amlodipine 10 mg tablet (PRO00011685/Niravath)	Dose: --	Route: oral	daily for 6 doses			Offset: 0 Hours	Instructions:	Take one tablet by mouth at least 30 minutes PRIOR to L-NMMA infusion, as instructed by the research staff. To be started 24 hours prior to L-NMMA infusion and then daily on days of L-NMMA infusion. Hold for SBP less than 100 mmHg.			Vitals
  	VITAL SIGNS - T/P/R/BP PER UNIT PROTOCOL	Interval: --	Occurrences: --	Comments:	Blood Pressure must be monitored every 30 minutes during L-NMMA Infusion.  Patient should also be monitored for 30 minutes post-infusion

If Systolic BP GREATER than 180 mm Hg, STOP Infusion.  Recheck in 30 minutes.
If Systolic BP DECREASES to LESS than 160 mm Hg, Restart Infusion.  
If Still GREATER than 160 mm Hg, Recheck in 15-30 minutes.
If Systolic BP GREATER than 160 mm Hg a Second Time, Discontinue Infusion and Contact MD and Research Coordinator.
If Infusion is Restarted and Systolic BP Increases to GREATER than 180 mm Hg a second time, Discontinue Infusion and Contact MD and Research Coordinator.
			Biologicals
  	INV L-NMMA (PRO00011685/Niravath) IVPB in sodium chloride 0.9%	Dose: --	Route: intravenous	once over 2 Hours for 1 dose			Offset: 0 Hours	Instructions:	L-NMMA dosage will de-escalate/escalate based on the CRM. Contains active study drug L-NMMA in NS, total volume 100 mL. Prepared bag is stable for 4 hours when refrigerated. Infuse intravenously over 2 hours. Caution: Limited by Federal (USA) Law to Investigational Drug.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV L-NMMA (PRO00011685/NIRAVATH) VIAL	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes				Emergency Medications
  	ONC NURSING COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	Notify covering provider of reaction and symptoms.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once PRN				Instructions:	May repeat once after 15 minutes if needed. If given IV, administer 25 mg over 1 minute or 50 mg over 2 minutes.		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once PRN				Instructions:	If given IV, administer 25 mg over 1 minute or 50 mg over 2 minutes.		  	dexAMETHasone (DECADRON) IV 10 mg	Dose: 10 mg	Route: intravenous	once PRN	Start: S			Instructions:	Administer over 1 minute.		  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once PRN	Start: S					Supportive Care
  	pegfilgrastim (NEULASTA) on-body injection kit 6 mg	Dose: 6 mg	Route: subcutaneous	once for 1 dose				Instructions:	To inject at least 24 hours after chemotherapy complete.			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.
				Day 3	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 5	Interval: --	Occurrences: --			Vitals
  	VITAL SIGNS - T/P/R/BP PER UNIT PROTOCOL	Interval: --	Occurrences: --	Comments:	Obtain Height with first visit; Weight with every visit. 
Monitor BP, HR, Temp, RR with Every visit.
			Pre-Medications
  	INV amlodipine 10 mg tablet (PRO00011685/Niravath)	Dose: --	Route: oral	daily for 6 doses			Offset: 0 Hours	Instructions:	Take one tablet by mouth at least 30 minutes PRIOR to L-NMMA infusion, as instructed by the research staff. To be started 24 hours prior to L-NMMA infusion and then daily on days of L-NMMA infusion. Hold for SBP less than 100 mmHg.			Vitals
  	VITAL SIGNS - T/P/R/BP PER UNIT PROTOCOL	Interval: --	Occurrences: --	Comments:	Blood Pressure must be monitored every 30 minutes during L-NMMA Infusion.  Patient should also be monitored for 30 minutes post-infusion

If Systolic BP GREATER than 180 mm Hg, STOP Infusion.  Recheck in 30 minutes.
If Systolic BP DECREASES to LESS than 160 mm Hg, Restart Infusion.  
If Still GREATER than 160 mm Hg, Recheck in 15-30 minutes.
If Systolic BP GREATER than 160 mm Hg a Second Time, Discontinue Infusion and Contact MD and Research Coordinator.
If Infusion is Restarted and Systolic BP Increases to GREATER than 180 mm Hg a second time, Discontinue Infusion and Contact MD and Research Coordinator.
			Biologicals
  	INV L-NMMA (PRO00011685/Niravath) IVPB in sodium chloride 0.9%	Dose: --	Route: intravenous	once over 2 Hours for 1 dose			Offset: 0 Hours	Instructions:	L-NMMA dosage will de-escalate/escalate based on the CRM. Contains active study drug L-NMMA in NS, total volume 100 mL. Prepared bag is stable for 4 hours when refrigerated. Infuse intravenously over 2 hours. Caution: Limited by Federal (USA) Law to Investigational Drug.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV L-NMMA (PRO00011685/NIRAVATH) VIAL	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes				Emergency Medications
  	ONC NURSING COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	Notify covering provider of reaction and symptoms.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once PRN				Instructions:	May repeat once after 15 minutes if needed. If given IV, administer 25 mg over 1 minute or 50 mg over 2 minutes.		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once PRN				Instructions:	If given IV, administer 25 mg over 1 minute or 50 mg over 2 minutes.		  	dexAMETHasone (DECADRON) IV 10 mg	Dose: 10 mg	Route: intravenous	once PRN	Start: S			Instructions:	Administer over 1 minute.		  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once PRN	Start: S					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.
				Day 4	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 5	Interval: --	Occurrences: --			Vitals
  	VITAL SIGNS - T/P/R/BP PER UNIT PROTOCOL	Interval: --	Occurrences: --	Comments:	Obtain Height with first visit; Weight with every visit. 
Monitor BP, HR, Temp, RR with Every visit.
			Pre-Medications
  	INV amlodipine 10 mg tablet (PRO00011685/Niravath)	Dose: --	Route: oral	daily for 6 doses			Offset: 0 Hours	Instructions:	Take one tablet by mouth at least 30 minutes PRIOR to L-NMMA infusion, as instructed by the research staff. To be started 24 hours prior to L-NMMA infusion and then daily on days of L-NMMA infusion. Hold for SBP less than 100 mmHg.			Vitals
  	VITAL SIGNS - T/P/R/BP PER UNIT PROTOCOL	Interval: --	Occurrences: --	Comments:	Blood Pressure must be monitored every 30 minutes during L-NMMA Infusion.  Patient should also be monitored for 30 minutes post-infusion

If Systolic BP GREATER than 180 mm Hg, STOP Infusion.  Recheck in 30 minutes.
If Systolic BP DECREASES to LESS than 160 mm Hg, Restart Infusion.  
If Still GREATER than 160 mm Hg, Recheck in 15-30 minutes.
If Systolic BP GREATER than 160 mm Hg a Second Time, Discontinue Infusion and Contact MD and Research Coordinator.
If Infusion is Restarted and Systolic BP Increases to GREATER than 180 mm Hg a second time, Discontinue Infusion and Contact MD and Research Coordinator.
			Biologicals
  	INV L-NMMA (PRO00011685/Niravath) IVPB in sodium chloride 0.9%	Dose: --	Route: intravenous	once over 2 Hours for 1 dose			Offset: 0 Hours	Instructions:	L-NMMA dosage will de-escalate/escalate based on the CRM. Contains active study drug L-NMMA in NS, total volume 100 mL. Prepared bag is stable for 4 hours when refrigerated. Infuse intravenously over 2 hours. Caution: Limited by Federal (USA) Law to Investigational Drug.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV L-NMMA (PRO00011685/NIRAVATH) VIAL	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes				Emergency Medications
  	ONC NURSING COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	Notify covering provider of reaction and symptoms.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once PRN				Instructions:	May repeat once after 15 minutes if needed. If given IV, administer 25 mg over 1 minute or 50 mg over 2 minutes.		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once PRN				Instructions:	If given IV, administer 25 mg over 1 minute or 50 mg over 2 minutes.		  	dexAMETHasone (DECADRON) IV 10 mg	Dose: 10 mg	Route: intravenous	once PRN	Start: S			Instructions:	Administer over 1 minute.		  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once PRN	Start: S					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.
				Day 5	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 5	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 105	Interval: --	Occurrences: --	Comments:	Research Coordinator:  Imaging due prior to Cycle 3, Day 1: CT of Chest, Abdomen, and Pelvis with and without Oral and IV Contrast.   Please schedule appropriately.
			Vitals
  	VITAL SIGNS - T/P/R/BP PER UNIT PROTOCOL	Interval: --	Occurrences: --	Comments:	Obtain Height with first visit; Weight with every visit. 
Monitor BP, HR, Temp, RR with Every visit.
			Pre-Medications
  	INV amlodipine 10 mg tablet (PRO00011685/Niravath)	Dose: --	Route: oral	daily for 6 doses			Offset: 0 Hours	Instructions:	Take one tablet by mouth at least 30 minutes PRIOR to L-NMMA infusion, as instructed by the research staff. To be started 24 hours prior to L-NMMA infusion and then daily on days of L-NMMA infusion. Hold for SBP less than 100 mmHg.			Vitals
  	VITAL SIGNS - T/P/R/BP PER UNIT PROTOCOL	Interval: --	Occurrences: --	Comments:	Blood Pressure must be monitored every 30 minutes during L-NMMA Infusion.  Patient should also be monitored for 30 minutes post-infusion

If Systolic BP GREATER than 180 mm Hg, STOP Infusion.  Recheck in 30 minutes.
If Systolic BP DECREASES to LESS than 160 mm Hg, Restart Infusion.  
If Still GREATER than 160 mm Hg, Recheck in 15-30 minutes.
If Systolic BP GREATER than 160 mm Hg a Second Time, Discontinue Infusion and Contact MD and Research Coordinator.
If Infusion is Restarted and Systolic BP Increases to GREATER than 180 mm Hg a second time, Discontinue Infusion and Contact MD and Research Coordinator.
			Biologicals
  	INV L-NMMA (PRO00011685/Niravath) IVPB in sodium chloride 0.9%	Dose: --	Route: intravenous	once over 2 Hours for 1 dose			Offset: 0 Hours	Instructions:	L-NMMA dosage will de-escalate/escalate based on the CRM. Contains active study drug L-NMMA in NS, total volume 100 mL. Prepared bag is stable for 4 hours when refrigerated. Infuse intravenously over 2 hours. Caution: Limited by Federal (USA) Law to Investigational Drug.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV L-NMMA (PRO00011685/NIRAVATH) VIAL	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes				Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Emergency Medications
  	ONC NURSING COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	Notify covering provider of reaction and symptoms.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once PRN				Instructions:	May repeat once after 15 minutes if needed. If given IV, administer 25 mg over 1 minute or 50 mg over 2 minutes.		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once PRN				Instructions:	If given IV, administer 25 mg over 1 minute or 50 mg over 2 minutes.		  	dexAMETHasone (DECADRON) IV 10 mg	Dose: 10 mg	Route: intravenous	once PRN	Start: S			Instructions:	Administer over 1 minute.		  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once PRN	Start: S					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.
					
Cycle 3	Repeat 1 time	Cycle length: 21 days	Day 0	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 105	Interval: --	Occurrences: --	Comments:	Research Coordinator:  Imaging due prior to Cycle 3, Day 1: CT of Chest, Abdomen, and Pelvis with and without Oral and IV Contrast.   Please schedule appropriately.
			Vitals
  	VITAL SIGNS - T/P/R/BP PER UNIT PROTOCOL	Interval: --	Occurrences: --	Comments:	Obtain Height with first visit; Weight with every visit. 
Monitor BP, HR, Temp, RR with Every visit.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	URIC ACID LEVEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --			Pre-Medications
  	INV amlodipine 10 mg tablet, PRO00011685/Niravath, 10 mg	Dose: --	Route: oral	daily	Dispense: --	Refills: --	Start: S	End: S+6		Instructions:	Start taking 24 hours PRIOR to the Day 1 L-NMMA Infusion.  Bring to infusion appointment.  Take at least 30 minutes PRIOR to L-NMMA Infusion on Days 1 through 5			Pre-Medications
  	dexamethasone (DECADRON) 4 MG tablet	Dose: 8 mg	Route: oral	daily	Dispense: 6 tablet	Refills: --	Start: S	End: S+3		Instructions:	Take the day before, the day of, and the day after DOCEtaxel infusion.				Prior to each Cycle	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 8	Interval: --	Occurrences: --			Vitals
  	VITAL SIGNS - T/P/R/BP PER UNIT PROTOCOL	Interval: --	Occurrences: --	Comments:	Obtain Height with first visit; Weight with every visit. 
Monitor BP, HR, Temp, RR with Every visit.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Pre-Medications
  	INV amlodipine 10 mg tablet (PRO00011685/Niravath)	Dose: --	Route: oral	daily for 6 doses			Offset: 0 Hours	Instructions:	Take one tablet by mouth at least 30 minutes PRIOR to L-NMMA infusion, as instructed by the research staff. To be started 24 hours prior to L-NMMA infusion and then daily on days of L-NMMA infusion. Hold for SBP less than 100 mmHg.			Vitals
  	VITAL SIGNS - T/P/R/BP PER UNIT PROTOCOL	Interval: --	Occurrences: --	Comments:	Blood Pressure must be monitored every 30 minutes during L-NMMA Infusion.  Patient should also be monitored for 30 minutes post-infusion

If Systolic BP GREATER than 180 mm Hg, STOP Infusion.  Recheck in 30 minutes.
If Systolic BP DECREASES to LESS than 160 mm Hg, Restart Infusion.  
If Still GREATER than 160 mm Hg, Recheck in 15-30 minutes.
If Systolic BP GREATER than 160 mm Hg a Second Time, Discontinue Infusion and Contact MD and Research Coordinator.
If Infusion is Restarted and Systolic BP Increases to GREATER than 180 mm Hg a second time, Discontinue Infusion and Contact MD and Research Coordinator.
			Biologicals
  	INV L-NMMA (PRO00011685/Niravath) IVPB in sodium chloride 0.9%	Dose: --	Route: intravenous	once over 2 Hours for 1 dose			Offset: 0 Hours	Instructions:	L-NMMA dosage will de-escalate/escalate based on the CRM. Contains active study drug L-NMMA in NS, total volume 100 mL. Prepared bag is stable for 4 hours when refrigerated. Infuse intravenously over 2 hours. Caution: Limited by Federal (USA) Law to Investigational Drug.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV L-NMMA (PRO00011685/NIRAVATH) VIAL	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes				Pre-Medications
  	ondansetron (ZOFRAN) IV 16 mg	Dose: 16 mg	Route: intravenous	once for 1 dose			Offset: 2 Hours			Antiemetics
  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 2.25 Hours			Chemotherapy
  	DOCEtaxel (TAXOTERE) 75 mg/m2 in sodium chloride (NON-PVC) 0.9 % 250 mL chemo IVPB	Dose: 75 mg/m2	Route: intravenous	once over 60 Minutes for 1 dose			Offset: 2.75 Hours	Instructions:	Administer through non-DEHP tubing; Use within 4 hours of preparation; Protect from light. Administer over 1 hour (+/- 10 minutes).	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	DOCETAXEL 80 MG/4 ML (20 MG/ML) INTRAVENOUS SOLUTION	Medications	75 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % IV SOLP (EXCEL;NON-PVC)	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) IV SOLP (EXCEL; NON-PVC)	QS Base	250 mL	No	Yes				Emergency Medications
  	ONC NURSING COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	Notify covering provider of reaction and symptoms.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once PRN				Instructions:	May repeat once after 15 minutes if needed. If given IV, administer 25 mg over 1 minute or 50 mg over 2 minutes.		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once PRN				Instructions:	If given IV, administer 25 mg over 1 minute or 50 mg over 2 minutes.		  	dexAMETHasone (DECADRON) IV 10 mg	Dose: 10 mg	Route: intravenous	once PRN	Start: S			Instructions:	Administer over 1 minute.		  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once PRN	Start: S					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.
				Day 2	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 5	Interval: --	Occurrences: --			Vitals
  	VITAL SIGNS - T/P/R/BP PER UNIT PROTOCOL	Interval: --	Occurrences: --	Comments:	Obtain Height with first visit; Weight with every visit. 
Monitor BP, HR, Temp, RR with Every visit.
			Pre-Medications
  	INV amlodipine 10 mg tablet (PRO00011685/Niravath)	Dose: --	Route: oral	daily for 6 doses			Offset: 0 Hours	Instructions:	Take one tablet by mouth at least 30 minutes PRIOR to L-NMMA infusion, as instructed by the research staff. To be started 24 hours prior to L-NMMA infusion and then daily on days of L-NMMA infusion. Hold for SBP less than 100 mmHg.			Vitals
  	VITAL SIGNS - T/P/R/BP PER UNIT PROTOCOL	Interval: --	Occurrences: --	Comments:	Blood Pressure must be monitored every 30 minutes during L-NMMA Infusion.  Patient should also be monitored for 30 minutes post-infusion

If Systolic BP GREATER than 180 mm Hg, STOP Infusion.  Recheck in 30 minutes.
If Systolic BP DECREASES to LESS than 160 mm Hg, Restart Infusion.  
If Still GREATER than 160 mm Hg, Recheck in 15-30 minutes.
If Systolic BP GREATER than 160 mm Hg a Second Time, Discontinue Infusion and Contact MD and Research Coordinator.
If Infusion is Restarted and Systolic BP Increases to GREATER than 180 mm Hg a second time, Discontinue Infusion and Contact MD and Research Coordinator.
			Biologicals
  	INV L-NMMA (PRO00011685/Niravath) IVPB in sodium chloride 0.9%	Dose: --	Route: intravenous	once over 2 Hours for 1 dose			Offset: 0 Hours	Instructions:	L-NMMA dosage will de-escalate/escalate based on the CRM. Contains active study drug L-NMMA in NS, total volume 100 mL. Prepared bag is stable for 4 hours when refrigerated. Infuse intravenously over 2 hours. Caution: Limited by Federal (USA) Law to Investigational Drug.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV L-NMMA (PRO00011685/NIRAVATH) VIAL	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes				Emergency Medications
  	ONC NURSING COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	Notify covering provider of reaction and symptoms.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once PRN				Instructions:	May repeat once after 15 minutes if needed. If given IV, administer 25 mg over 1 minute or 50 mg over 2 minutes.		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once PRN				Instructions:	If given IV, administer 25 mg over 1 minute or 50 mg over 2 minutes.		  	dexAMETHasone (DECADRON) IV 10 mg	Dose: 10 mg	Route: intravenous	once PRN	Start: S			Instructions:	Administer over 1 minute.		  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once PRN	Start: S					Supportive Care
  	pegfilgrastim (NEULASTA) on-body injection kit 6 mg	Dose: 6 mg	Route: subcutaneous	once for 1 dose				Instructions:	To inject at least 24 hours after chemotherapy complete.			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.
				Day 3	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 5	Interval: --	Occurrences: --			Vitals
  	VITAL SIGNS - T/P/R/BP PER UNIT PROTOCOL	Interval: --	Occurrences: --	Comments:	Obtain Height with first visit; Weight with every visit. 
Monitor BP, HR, Temp, RR with Every visit.
			Pre-Medications
  	INV amlodipine 10 mg tablet (PRO00011685/Niravath)	Dose: --	Route: oral	daily for 6 doses			Offset: 0 Hours	Instructions:	Take one tablet by mouth at least 30 minutes PRIOR to L-NMMA infusion, as instructed by the research staff. To be started 24 hours prior to L-NMMA infusion and then daily on days of L-NMMA infusion. Hold for SBP less than 100 mmHg.			Vitals
  	VITAL SIGNS - T/P/R/BP PER UNIT PROTOCOL	Interval: --	Occurrences: --	Comments:	Blood Pressure must be monitored every 30 minutes during L-NMMA Infusion.  Patient should also be monitored for 30 minutes post-infusion

If Systolic BP GREATER than 180 mm Hg, STOP Infusion.  Recheck in 30 minutes.
If Systolic BP DECREASES to LESS than 160 mm Hg, Restart Infusion.  
If Still GREATER than 160 mm Hg, Recheck in 15-30 minutes.
If Systolic BP GREATER than 160 mm Hg a Second Time, Discontinue Infusion and Contact MD and Research Coordinator.
If Infusion is Restarted and Systolic BP Increases to GREATER than 180 mm Hg a second time, Discontinue Infusion and Contact MD and Research Coordinator.
			Biologicals
  	INV L-NMMA (PRO00011685/Niravath) IVPB in sodium chloride 0.9%	Dose: --	Route: intravenous	once over 2 Hours for 1 dose			Offset: 0 Hours	Instructions:	L-NMMA dosage will de-escalate/escalate based on the CRM. Contains active study drug L-NMMA in NS, total volume 100 mL. Prepared bag is stable for 4 hours when refrigerated. Infuse intravenously over 2 hours. Caution: Limited by Federal (USA) Law to Investigational Drug.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV L-NMMA (PRO00011685/NIRAVATH) VIAL	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes				Emergency Medications
  	ONC NURSING COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	Notify covering provider of reaction and symptoms.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once PRN				Instructions:	May repeat once after 15 minutes if needed. If given IV, administer 25 mg over 1 minute or 50 mg over 2 minutes.		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once PRN				Instructions:	If given IV, administer 25 mg over 1 minute or 50 mg over 2 minutes.		  	dexAMETHasone (DECADRON) IV 10 mg	Dose: 10 mg	Route: intravenous	once PRN	Start: S			Instructions:	Administer over 1 minute.		  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once PRN	Start: S					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.
				Day 4	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 5	Interval: --	Occurrences: --			Vitals
  	VITAL SIGNS - T/P/R/BP PER UNIT PROTOCOL	Interval: --	Occurrences: --	Comments:	Obtain Height with first visit; Weight with every visit. 
Monitor BP, HR, Temp, RR with Every visit.
			Pre-Medications
  	INV amlodipine 10 mg tablet (PRO00011685/Niravath)	Dose: --	Route: oral	daily for 6 doses			Offset: 0 Hours	Instructions:	Take one tablet by mouth at least 30 minutes PRIOR to L-NMMA infusion, as instructed by the research staff. To be started 24 hours prior to L-NMMA infusion and then daily on days of L-NMMA infusion. Hold for SBP less than 100 mmHg.			Vitals
  	VITAL SIGNS - T/P/R/BP PER UNIT PROTOCOL	Interval: --	Occurrences: --	Comments:	Blood Pressure must be monitored every 30 minutes during L-NMMA Infusion.  Patient should also be monitored for 30 minutes post-infusion

If Systolic BP GREATER than 180 mm Hg, STOP Infusion.  Recheck in 30 minutes.
If Systolic BP DECREASES to LESS than 160 mm Hg, Restart Infusion.  
If Still GREATER than 160 mm Hg, Recheck in 15-30 minutes.
If Systolic BP GREATER than 160 mm Hg a Second Time, Discontinue Infusion and Contact MD and Research Coordinator.
If Infusion is Restarted and Systolic BP Increases to GREATER than 180 mm Hg a second time, Discontinue Infusion and Contact MD and Research Coordinator.
			Biologicals
  	INV L-NMMA (PRO00011685/Niravath) IVPB in sodium chloride 0.9%	Dose: --	Route: intravenous	once over 2 Hours for 1 dose			Offset: 0 Hours	Instructions:	L-NMMA dosage will de-escalate/escalate based on the CRM. Contains active study drug L-NMMA in NS, total volume 100 mL. Prepared bag is stable for 4 hours when refrigerated. Infuse intravenously over 2 hours. Caution: Limited by Federal (USA) Law to Investigational Drug.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV L-NMMA (PRO00011685/NIRAVATH) VIAL	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes				Emergency Medications
  	ONC NURSING COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	Notify covering provider of reaction and symptoms.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once PRN				Instructions:	May repeat once after 15 minutes if needed. If given IV, administer 25 mg over 1 minute or 50 mg over 2 minutes.		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once PRN				Instructions:	If given IV, administer 25 mg over 1 minute or 50 mg over 2 minutes.		  	dexAMETHasone (DECADRON) IV 10 mg	Dose: 10 mg	Route: intravenous	once PRN	Start: S			Instructions:	Administer over 1 minute.		  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once PRN	Start: S					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.
				Day 5	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 5	Interval: --	Occurrences: --			Vitals
  	VITAL SIGNS - T/P/R/BP PER UNIT PROTOCOL	Interval: --	Occurrences: --	Comments:	Obtain Height with first visit; Weight with every visit. 
Monitor BP, HR, Temp, RR with Every visit.
			Pre-Medications
  	INV amlodipine 10 mg tablet (PRO00011685/Niravath)	Dose: --	Route: oral	daily for 6 doses			Offset: 0 Hours	Instructions:	Take one tablet by mouth at least 30 minutes PRIOR to L-NMMA infusion, as instructed by the research staff. To be started 24 hours prior to L-NMMA infusion and then daily on days of L-NMMA infusion. Hold for SBP less than 100 mmHg.			Vitals
  	VITAL SIGNS - T/P/R/BP PER UNIT PROTOCOL	Interval: --	Occurrences: --	Comments:	Blood Pressure must be monitored every 30 minutes during L-NMMA Infusion.  Patient should also be monitored for 30 minutes post-infusion

If Systolic BP GREATER than 180 mm Hg, STOP Infusion.  Recheck in 30 minutes.
If Systolic BP DECREASES to LESS than 160 mm Hg, Restart Infusion.  
If Still GREATER than 160 mm Hg, Recheck in 15-30 minutes.
If Systolic BP GREATER than 160 mm Hg a Second Time, Discontinue Infusion and Contact MD and Research Coordinator.
If Infusion is Restarted and Systolic BP Increases to GREATER than 180 mm Hg a second time, Discontinue Infusion and Contact MD and Research Coordinator.
			Biologicals
  	INV L-NMMA (PRO00011685/Niravath) IVPB in sodium chloride 0.9%	Dose: --	Route: intravenous	once over 2 Hours for 1 dose			Offset: 0 Hours	Instructions:	L-NMMA dosage will de-escalate/escalate based on the CRM. Contains active study drug L-NMMA in NS, total volume 100 mL. Prepared bag is stable for 4 hours when refrigerated. Infuse intravenously over 2 hours. Caution: Limited by Federal (USA) Law to Investigational Drug.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV L-NMMA (PRO00011685/NIRAVATH) VIAL	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes				Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Emergency Medications
  	ONC NURSING COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	Notify covering provider of reaction and symptoms.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once PRN				Instructions:	May repeat once after 15 minutes if needed. If given IV, administer 25 mg over 1 minute or 50 mg over 2 minutes.		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once PRN				Instructions:	If given IV, administer 25 mg over 1 minute or 50 mg over 2 minutes.		  	dexAMETHasone (DECADRON) IV 10 mg	Dose: 10 mg	Route: intravenous	once PRN	Start: S			Instructions:	Administer over 1 minute.		  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once PRN	Start: S					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.
					
Cycle 4	Repeat 1 time	Cycle length: 21 days	Day 0	Perform every 1 day x1		Vitals
  	VITAL SIGNS - T/P/R/BP PER UNIT PROTOCOL	Interval: --	Occurrences: --	Comments:	Obtain Height with first visit; Weight with every visit. 
Monitor BP, HR, Temp, RR with Every visit.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	URIC ACID LEVEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --			Pre-Medications
  	INV amlodipine 10 mg tablet, PRO00011685/Niravath, 10 mg	Dose: --	Route: oral	daily	Dispense: --	Refills: --	Start: S	End: S+6		Instructions:	Start taking 24 hours PRIOR to the Day 1 L-NMMA Infusion.  Bring to infusion appointment.  Take at least 30 minutes PRIOR to L-NMMA Infusion on Days 1 through 5			Pre-Medications
  	dexamethasone (DECADRON) 4 MG tablet	Dose: 8 mg	Route: oral	daily	Dispense: 6 tablet	Refills: --	Start: S	End: S+3		Instructions:	Take the day before, the day of, and the day after DOCEtaxel infusion.				Prior to each Cycle	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 8	Interval: --	Occurrences: --			Vitals
  	VITAL SIGNS - T/P/R/BP PER UNIT PROTOCOL	Interval: --	Occurrences: --	Comments:	Obtain Height with first visit; Weight with every visit. 
Monitor BP, HR, Temp, RR with Every visit.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	URIC ACID LEVEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Pre-Medications
  	INV amlodipine 10 mg tablet (PRO00011685/Niravath)	Dose: --	Route: oral	daily for 6 doses			Offset: 0 Hours	Instructions:	Take one tablet by mouth at least 30 minutes PRIOR to L-NMMA infusion, as instructed by the research staff. To be started 24 hours prior to L-NMMA infusion and then daily on days of L-NMMA infusion. Hold for SBP less than 100 mmHg.			Vitals
  	VITAL SIGNS - T/P/R/BP PER UNIT PROTOCOL	Interval: --	Occurrences: --	Comments:	Blood Pressure must be monitored every 30 minutes during L-NMMA Infusion.  Patient should also be monitored for 30 minutes post-infusion

If Systolic BP GREATER than 180 mm Hg, STOP Infusion.  Recheck in 30 minutes.
If Systolic BP DECREASES to LESS than 160 mm Hg, Restart Infusion.  
If Still GREATER than 160 mm Hg, Recheck in 15-30 minutes.
If Systolic BP GREATER than 160 mm Hg a Second Time, Discontinue Infusion and Contact MD and Research Coordinator.
If Infusion is Restarted and Systolic BP Increases to GREATER than 180 mm Hg a second time, Discontinue Infusion and Contact MD and Research Coordinator.
			Biologicals
  	INV L-NMMA (PRO00011685/Niravath) IVPB in sodium chloride 0.9%	Dose: --	Route: intravenous	once over 2 Hours for 1 dose			Offset: 0 Hours	Instructions:	L-NMMA dosage will de-escalate/escalate based on the CRM. Contains active study drug L-NMMA in NS, total volume 100 mL. Prepared bag is stable for 4 hours when refrigerated. Infuse intravenously over 2 hours. Caution: Limited by Federal (USA) Law to Investigational Drug.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV L-NMMA (PRO00011685/NIRAVATH) VIAL	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes				Pre-Medications
  	ondansetron (ZOFRAN) IV 16 mg	Dose: 16 mg	Route: intravenous	once for 1 dose			Offset: 2 Hours			Antiemetics
  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 2.25 Hours			Chemotherapy
  	DOCEtaxel (TAXOTERE) 75 mg/m2 in sodium chloride (NON-PVC) 0.9 % 250 mL chemo IVPB	Dose: 75 mg/m2	Route: intravenous	once over 60 Minutes for 1 dose			Offset: 2.75 Hours	Instructions:	Administer through non-DEHP tubing; Use within 4 hours of preparation; Protect from light. Administer over 1 hour (+/- 10 minutes).	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	DOCETAXEL 80 MG/4 ML (20 MG/ML) INTRAVENOUS SOLUTION	Medications	75 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % IV SOLP (EXCEL;NON-PVC)	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) IV SOLP (EXCEL; NON-PVC)	QS Base	250 mL	No	Yes				Emergency Medications
  	ONC NURSING COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	Notify covering provider of reaction and symptoms.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once PRN				Instructions:	May repeat once after 15 minutes if needed. If given IV, administer 25 mg over 1 minute or 50 mg over 2 minutes.		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once PRN				Instructions:	If given IV, administer 25 mg over 1 minute or 50 mg over 2 minutes.		  	dexAMETHasone (DECADRON) IV 10 mg	Dose: 10 mg	Route: intravenous	once PRN	Start: S			Instructions:	Administer over 1 minute.		  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once PRN	Start: S					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.
				Day 2	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 5	Interval: --	Occurrences: --			Vitals
  	VITAL SIGNS - T/P/R/BP PER UNIT PROTOCOL	Interval: --	Occurrences: --	Comments:	Obtain Height with first visit; Weight with every visit. 
Monitor BP, HR, Temp, RR with Every visit.
			Pre-Medications
  	INV amlodipine 10 mg tablet (PRO00011685/Niravath)	Dose: --	Route: oral	daily for 6 doses			Offset: 0 Hours	Instructions:	Take one tablet by mouth at least 30 minutes PRIOR to L-NMMA infusion, as instructed by the research staff. To be started 24 hours prior to L-NMMA infusion and then daily on days of L-NMMA infusion. Hold for SBP less than 100 mmHg.			Vitals
  	VITAL SIGNS - T/P/R/BP PER UNIT PROTOCOL	Interval: --	Occurrences: --	Comments:	Blood Pressure must be monitored every 30 minutes during L-NMMA Infusion.  Patient should also be monitored for 30 minutes post-infusion

If Systolic BP GREATER than 180 mm Hg, STOP Infusion.  Recheck in 30 minutes.
If Systolic BP DECREASES to LESS than 160 mm Hg, Restart Infusion.  
If Still GREATER than 160 mm Hg, Recheck in 15-30 minutes.
If Systolic BP GREATER than 160 mm Hg a Second Time, Discontinue Infusion and Contact MD and Research Coordinator.
If Infusion is Restarted and Systolic BP Increases to GREATER than 180 mm Hg a second time, Discontinue Infusion and Contact MD and Research Coordinator.
			Biologicals
  	INV L-NMMA (PRO00011685/Niravath) IVPB in sodium chloride 0.9%	Dose: --	Route: intravenous	once over 2 Hours for 1 dose			Offset: 0 Hours	Instructions:	L-NMMA dosage will de-escalate/escalate based on the CRM. Contains active study drug L-NMMA in NS, total volume 100 mL. Prepared bag is stable for 4 hours when refrigerated. Infuse intravenously over 2 hours. Caution: Limited by Federal (USA) Law to Investigational Drug.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV L-NMMA (PRO00011685/NIRAVATH) VIAL	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes				Emergency Medications
  	ONC NURSING COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	Notify covering provider of reaction and symptoms.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once PRN				Instructions:	May repeat once after 15 minutes if needed. If given IV, administer 25 mg over 1 minute or 50 mg over 2 minutes.		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once PRN				Instructions:	If given IV, administer 25 mg over 1 minute or 50 mg over 2 minutes.		  	dexAMETHasone (DECADRON) IV 10 mg	Dose: 10 mg	Route: intravenous	once PRN	Start: S			Instructions:	Administer over 1 minute.		  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once PRN	Start: S					Supportive Care
  	pegfilgrastim (NEULASTA) on-body injection kit 6 mg	Dose: 6 mg	Route: subcutaneous	once for 1 dose				Instructions:	To inject at least 24 hours after chemotherapy complete.			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.
				Day 3	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 5	Interval: --	Occurrences: --			Vitals
  	VITAL SIGNS - T/P/R/BP PER UNIT PROTOCOL	Interval: --	Occurrences: --	Comments:	Obtain Height with first visit; Weight with every visit. 
Monitor BP, HR, Temp, RR with Every visit.
			Pre-Medications
  	INV amlodipine 10 mg tablet (PRO00011685/Niravath)	Dose: --	Route: oral	daily for 6 doses			Offset: 0 Hours	Instructions:	Take one tablet by mouth at least 30 minutes PRIOR to L-NMMA infusion, as instructed by the research staff. To be started 24 hours prior to L-NMMA infusion and then daily on days of L-NMMA infusion. Hold for SBP less than 100 mmHg.			Vitals
  	VITAL SIGNS - T/P/R/BP PER UNIT PROTOCOL	Interval: --	Occurrences: --	Comments:	Blood Pressure must be monitored every 30 minutes during L-NMMA Infusion.  Patient should also be monitored for 30 minutes post-infusion

If Systolic BP GREATER than 180 mm Hg, STOP Infusion.  Recheck in 30 minutes.
If Systolic BP DECREASES to LESS than 160 mm Hg, Restart Infusion.  
If Still GREATER than 160 mm Hg, Recheck in 15-30 minutes.
If Systolic BP GREATER than 160 mm Hg a Second Time, Discontinue Infusion and Contact MD and Research Coordinator.
If Infusion is Restarted and Systolic BP Increases to GREATER than 180 mm Hg a second time, Discontinue Infusion and Contact MD and Research Coordinator.
			Biologicals
  	INV L-NMMA (PRO00011685/Niravath) IVPB in sodium chloride 0.9%	Dose: --	Route: intravenous	once over 2 Hours for 1 dose			Offset: 0 Hours	Instructions:	L-NMMA dosage will de-escalate/escalate based on the CRM. Contains active study drug L-NMMA in NS, total volume 100 mL. Prepared bag is stable for 4 hours when refrigerated. Infuse intravenously over 2 hours. Caution: Limited by Federal (USA) Law to Investigational Drug.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV L-NMMA (PRO00011685/NIRAVATH) VIAL	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes				Emergency Medications
  	ONC NURSING COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	Notify covering provider of reaction and symptoms.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once PRN				Instructions:	May repeat once after 15 minutes if needed. If given IV, administer 25 mg over 1 minute or 50 mg over 2 minutes.		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once PRN				Instructions:	If given IV, administer 25 mg over 1 minute or 50 mg over 2 minutes.		  	dexAMETHasone (DECADRON) IV 10 mg	Dose: 10 mg	Route: intravenous	once PRN	Start: S			Instructions:	Administer over 1 minute.		  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once PRN	Start: S					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.
				Day 4	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 5	Interval: --	Occurrences: --			Vitals
  	VITAL SIGNS - T/P/R/BP PER UNIT PROTOCOL	Interval: --	Occurrences: --	Comments:	Obtain Height with first visit; Weight with every visit. 
Monitor BP, HR, Temp, RR with Every visit.
			Pre-Medications
  	INV amlodipine 10 mg tablet (PRO00011685/Niravath)	Dose: --	Route: oral	daily for 6 doses			Offset: 0 Hours	Instructions:	Take one tablet by mouth at least 30 minutes PRIOR to L-NMMA infusion, as instructed by the research staff. To be started 24 hours prior to L-NMMA infusion and then daily on days of L-NMMA infusion. Hold for SBP less than 100 mmHg.			Vitals
  	VITAL SIGNS - T/P/R/BP PER UNIT PROTOCOL	Interval: --	Occurrences: --	Comments:	Blood Pressure must be monitored every 30 minutes during L-NMMA Infusion.  Patient should also be monitored for 30 minutes post-infusion

If Systolic BP GREATER than 180 mm Hg, STOP Infusion.  Recheck in 30 minutes.
If Systolic BP DECREASES to LESS than 160 mm Hg, Restart Infusion.  
If Still GREATER than 160 mm Hg, Recheck in 15-30 minutes.
If Systolic BP GREATER than 160 mm Hg a Second Time, Discontinue Infusion and Contact MD and Research Coordinator.
If Infusion is Restarted and Systolic BP Increases to GREATER than 180 mm Hg a second time, Discontinue Infusion and Contact MD and Research Coordinator.
			Biologicals
  	INV L-NMMA (PRO00011685/Niravath) IVPB in sodium chloride 0.9%	Dose: --	Route: intravenous	once over 2 Hours for 1 dose			Offset: 0 Hours	Instructions:	L-NMMA dosage will de-escalate/escalate based on the CRM. Contains active study drug L-NMMA in NS, total volume 100 mL. Prepared bag is stable for 4 hours when refrigerated. Infuse intravenously over 2 hours. Caution: Limited by Federal (USA) Law to Investigational Drug.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV L-NMMA (PRO00011685/NIRAVATH) VIAL	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes				Emergency Medications
  	ONC NURSING COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	Notify covering provider of reaction and symptoms.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once PRN				Instructions:	May repeat once after 15 minutes if needed. If given IV, administer 25 mg over 1 minute or 50 mg over 2 minutes.		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once PRN				Instructions:	If given IV, administer 25 mg over 1 minute or 50 mg over 2 minutes.		  	dexAMETHasone (DECADRON) IV 10 mg	Dose: 10 mg	Route: intravenous	once PRN	Start: S			Instructions:	Administer over 1 minute.		  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once PRN	Start: S					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.
				Day 5	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 5	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 105	Interval: --	Occurrences: --	Comments:	Research Coordinator:  Imaging due prior to Cycle 5, Day 1: CT of Chest, Abdomen, and Pelvis with and without Oral and IV Contrast.   Please schedule appropriately.
			Vitals
  	VITAL SIGNS - T/P/R/BP PER UNIT PROTOCOL	Interval: --	Occurrences: --	Comments:	Obtain Height with first visit; Weight with every visit. 
Monitor BP, HR, Temp, RR with Every visit.
			Pre-Medications
  	INV amlodipine 10 mg tablet (PRO00011685/Niravath)	Dose: --	Route: oral	daily for 6 doses			Offset: 0 Hours	Instructions:	Take one tablet by mouth at least 30 minutes PRIOR to L-NMMA infusion, as instructed by the research staff. To be started 24 hours prior to L-NMMA infusion and then daily on days of L-NMMA infusion. Hold for SBP less than 100 mmHg.			Vitals
  	VITAL SIGNS - T/P/R/BP PER UNIT PROTOCOL	Interval: --	Occurrences: --	Comments:	Blood Pressure must be monitored every 30 minutes during L-NMMA Infusion.  Patient should also be monitored for 30 minutes post-infusion

If Systolic BP GREATER than 180 mm Hg, STOP Infusion.  Recheck in 30 minutes.
If Systolic BP DECREASES to LESS than 160 mm Hg, Restart Infusion.  
If Still GREATER than 160 mm Hg, Recheck in 15-30 minutes.
If Systolic BP GREATER than 160 mm Hg a Second Time, Discontinue Infusion and Contact MD and Research Coordinator.
If Infusion is Restarted and Systolic BP Increases to GREATER than 180 mm Hg a second time, Discontinue Infusion and Contact MD and Research Coordinator.
			Biologicals
  	INV L-NMMA (PRO00011685/Niravath) IVPB in sodium chloride 0.9%	Dose: --	Route: intravenous	once over 2 Hours for 1 dose			Offset: 0 Hours	Instructions:	L-NMMA dosage will de-escalate/escalate based on the CRM. Contains active study drug L-NMMA in NS, total volume 100 mL. Prepared bag is stable for 4 hours when refrigerated. Infuse intravenously over 2 hours. Caution: Limited by Federal (USA) Law to Investigational Drug.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV L-NMMA (PRO00011685/NIRAVATH) VIAL	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes				Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Emergency Medications
  	ONC NURSING COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	Notify covering provider of reaction and symptoms.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once PRN				Instructions:	May repeat once after 15 minutes if needed. If given IV, administer 25 mg over 1 minute or 50 mg over 2 minutes.		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once PRN				Instructions:	If given IV, administer 25 mg over 1 minute or 50 mg over 2 minutes.		  	dexAMETHasone (DECADRON) IV 10 mg	Dose: 10 mg	Route: intravenous	once PRN	Start: S			Instructions:	Administer over 1 minute.		  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once PRN	Start: S					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.
					
Cycle 5	Repeat 1 time	Cycle length: 21 days	Day 0	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 105	Interval: --	Occurrences: --	Comments:	Research Coordinator:  Imaging due prior to Cycle 5, Day 1: CT of Chest, Abdomen, and Pelvis with and without Oral and IV Contrast.   Please schedule appropriately.
			Vitals
  	VITAL SIGNS - T/P/R/BP PER UNIT PROTOCOL	Interval: --	Occurrences: --	Comments:	Obtain Height with first visit; Weight with every visit. 
Monitor BP, HR, Temp, RR with Every visit.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	URIC ACID LEVEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --			Pre-Medications
  	INV amlodipine 10 mg tablet, PRO00011685/Niravath, 10 mg	Dose: --	Route: oral	daily	Dispense: --	Refills: --	Start: S	End: S+6		Instructions:	Start taking 24 hours PRIOR to the Day 1 L-NMMA Infusion.  Bring to infusion appointment.  Take at least 30 minutes PRIOR to L-NMMA Infusion on Days 1 through 5			Pre-Medications
  	dexamethasone (DECADRON) 4 MG tablet	Dose: 8 mg	Route: oral	daily	Dispense: 6 tablet	Refills: --	Start: S	End: S+3		Instructions:	Take the day before, the day of, and the day after DOCEtaxel infusion.				Prior to each Cycle	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 8	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 105	Interval: --	Occurrences: --	Comments:	Research Coordinator:  Imaging due prior to Cycle 5, Day 1: CT of Chest, Abdomen, and Pelvis with and without Oral and IV Contrast.   Please schedule appropriately.
			Vitals
  	VITAL SIGNS - T/P/R/BP PER UNIT PROTOCOL	Interval: --	Occurrences: --	Comments:	Obtain Height with first visit; Weight with every visit. 
Monitor BP, HR, Temp, RR with Every visit.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Pre-Medications
  	INV amlodipine 10 mg tablet (PRO00011685/Niravath)	Dose: --	Route: oral	daily for 6 doses			Offset: 0 Hours	Instructions:	Take one tablet by mouth at least 30 minutes PRIOR to L-NMMA infusion, as instructed by the research staff. To be started 24 hours prior to L-NMMA infusion and then daily on days of L-NMMA infusion. Hold for SBP less than 100 mmHg.			Vitals
  	VITAL SIGNS - T/P/R/BP PER UNIT PROTOCOL	Interval: --	Occurrences: --	Comments:	Blood Pressure must be monitored every 30 minutes during L-NMMA Infusion.  Patient should also be monitored for 30 minutes post-infusion

If Systolic BP GREATER than 180 mm Hg, STOP Infusion.  Recheck in 30 minutes.
If Systolic BP DECREASES to LESS than 160 mm Hg, Restart Infusion.  
If Still GREATER than 160 mm Hg, Recheck in 15-30 minutes.
If Systolic BP GREATER than 160 mm Hg a Second Time, Discontinue Infusion and Contact MD and Research Coordinator.
If Infusion is Restarted and Systolic BP Increases to GREATER than 180 mm Hg a second time, Discontinue Infusion and Contact MD and Research Coordinator.
			Biologicals
  	INV L-NMMA (PRO00011685/Niravath) IVPB in sodium chloride 0.9%	Dose: --	Route: intravenous	once over 2 Hours for 1 dose			Offset: 0 Hours	Instructions:	L-NMMA dosage will de-escalate/escalate based on the CRM. Contains active study drug L-NMMA in NS, total volume 100 mL. Prepared bag is stable for 4 hours when refrigerated. Infuse intravenously over 2 hours. Caution: Limited by Federal (USA) Law to Investigational Drug.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV L-NMMA (PRO00011685/NIRAVATH) VIAL	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes				Pre-Medications
  	ondansetron (ZOFRAN) IV 16 mg	Dose: 16 mg	Route: intravenous	once for 1 dose			Offset: 2 Hours			Antiemetics
  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 2.25 Hours			Chemotherapy
  	DOCEtaxel (TAXOTERE) 75 mg/m2 in sodium chloride (NON-PVC) 0.9 % 250 mL chemo IVPB	Dose: 75 mg/m2	Route: intravenous	once over 60 Minutes for 1 dose			Offset: 2.75 Hours	Instructions:	Administer through non-DEHP tubing; Use within 4 hours of preparation; Protect from light. Administer over 1 hour (+/- 10 minutes).	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	DOCETAXEL 80 MG/4 ML (20 MG/ML) INTRAVENOUS SOLUTION	Medications	75 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % IV SOLP (EXCEL;NON-PVC)	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) IV SOLP (EXCEL; NON-PVC)	QS Base	250 mL	No	Yes				Emergency Medications
  	ONC NURSING COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	Notify covering provider of reaction and symptoms.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once PRN				Instructions:	May repeat once after 15 minutes if needed. If given IV, administer 25 mg over 1 minute or 50 mg over 2 minutes.		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once PRN				Instructions:	If given IV, administer 25 mg over 1 minute or 50 mg over 2 minutes.		  	dexAMETHasone (DECADRON) IV 10 mg	Dose: 10 mg	Route: intravenous	once PRN	Start: S			Instructions:	Administer over 1 minute.		  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once PRN	Start: S					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.
				Day 2	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 5	Interval: --	Occurrences: --			Vitals
  	VITAL SIGNS - T/P/R/BP PER UNIT PROTOCOL	Interval: --	Occurrences: --	Comments:	Obtain Height with first visit; Weight with every visit. 
Monitor BP, HR, Temp, RR with Every visit.
			Pre-Medications
  	INV amlodipine 10 mg tablet (PRO00011685/Niravath)	Dose: --	Route: oral	daily for 6 doses			Offset: 0 Hours	Instructions:	Take one tablet by mouth at least 30 minutes PRIOR to L-NMMA infusion, as instructed by the research staff. To be started 24 hours prior to L-NMMA infusion and then daily on days of L-NMMA infusion. Hold for SBP less than 100 mmHg.			Vitals
  	VITAL SIGNS - T/P/R/BP PER UNIT PROTOCOL	Interval: --	Occurrences: --	Comments:	Blood Pressure must be monitored every 30 minutes during L-NMMA Infusion.  Patient should also be monitored for 30 minutes post-infusion

If Systolic BP GREATER than 180 mm Hg, STOP Infusion.  Recheck in 30 minutes.
If Systolic BP DECREASES to LESS than 160 mm Hg, Restart Infusion.  
If Still GREATER than 160 mm Hg, Recheck in 15-30 minutes.
If Systolic BP GREATER than 160 mm Hg a Second Time, Discontinue Infusion and Contact MD and Research Coordinator.
If Infusion is Restarted and Systolic BP Increases to GREATER than 180 mm Hg a second time, Discontinue Infusion and Contact MD and Research Coordinator.
			Biologicals
  	INV L-NMMA (PRO00011685/Niravath) IVPB in sodium chloride 0.9%	Dose: --	Route: intravenous	once over 2 Hours for 1 dose			Offset: 0 Hours	Instructions:	L-NMMA dosage will de-escalate/escalate based on the CRM. Contains active study drug L-NMMA in NS, total volume 100 mL. Prepared bag is stable for 4 hours when refrigerated. Infuse intravenously over 2 hours. Caution: Limited by Federal (USA) Law to Investigational Drug.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV L-NMMA (PRO00011685/NIRAVATH) VIAL	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes				Emergency Medications
  	ONC NURSING COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	Notify covering provider of reaction and symptoms.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once PRN				Instructions:	May repeat once after 15 minutes if needed. If given IV, administer 25 mg over 1 minute or 50 mg over 2 minutes.		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once PRN				Instructions:	If given IV, administer 25 mg over 1 minute or 50 mg over 2 minutes.		  	dexAMETHasone (DECADRON) IV 10 mg	Dose: 10 mg	Route: intravenous	once PRN	Start: S			Instructions:	Administer over 1 minute.		  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once PRN	Start: S					Supportive Care
  	pegfilgrastim (NEULASTA) on-body injection kit 6 mg	Dose: 6 mg	Route: subcutaneous	once for 1 dose				Instructions:	To inject at least 24 hours after chemotherapy complete.			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.
				Day 3	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 5	Interval: --	Occurrences: --			Vitals
  	VITAL SIGNS - T/P/R/BP PER UNIT PROTOCOL	Interval: --	Occurrences: --	Comments:	Obtain Height with first visit; Weight with every visit. 
Monitor BP, HR, Temp, RR with Every visit.
			Pre-Medications
  	INV amlodipine 10 mg tablet (PRO00011685/Niravath)	Dose: --	Route: oral	daily for 6 doses			Offset: 0 Hours	Instructions:	Take one tablet by mouth at least 30 minutes PRIOR to L-NMMA infusion, as instructed by the research staff. To be started 24 hours prior to L-NMMA infusion and then daily on days of L-NMMA infusion. Hold for SBP less than 100 mmHg.			Vitals
  	VITAL SIGNS - T/P/R/BP PER UNIT PROTOCOL	Interval: --	Occurrences: --	Comments:	Blood Pressure must be monitored every 30 minutes during L-NMMA Infusion.  Patient should also be monitored for 30 minutes post-infusion

If Systolic BP GREATER than 180 mm Hg, STOP Infusion.  Recheck in 30 minutes.
If Systolic BP DECREASES to LESS than 160 mm Hg, Restart Infusion.  
If Still GREATER than 160 mm Hg, Recheck in 15-30 minutes.
If Systolic BP GREATER than 160 mm Hg a Second Time, Discontinue Infusion and Contact MD and Research Coordinator.
If Infusion is Restarted and Systolic BP Increases to GREATER than 180 mm Hg a second time, Discontinue Infusion and Contact MD and Research Coordinator.
			Biologicals
  	INV L-NMMA (PRO00011685/Niravath) IVPB in sodium chloride 0.9%	Dose: --	Route: intravenous	once over 2 Hours for 1 dose			Offset: 0 Hours	Instructions:	L-NMMA dosage will de-escalate/escalate based on the CRM. Contains active study drug L-NMMA in NS, total volume 100 mL. Prepared bag is stable for 4 hours when refrigerated. Infuse intravenously over 2 hours. Caution: Limited by Federal (USA) Law to Investigational Drug.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV L-NMMA (PRO00011685/NIRAVATH) VIAL	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes				Emergency Medications
  	ONC NURSING COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	Notify covering provider of reaction and symptoms.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once PRN				Instructions:	May repeat once after 15 minutes if needed. If given IV, administer 25 mg over 1 minute or 50 mg over 2 minutes.		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once PRN				Instructions:	If given IV, administer 25 mg over 1 minute or 50 mg over 2 minutes.		  	dexAMETHasone (DECADRON) IV 10 mg	Dose: 10 mg	Route: intravenous	once PRN	Start: S			Instructions:	Administer over 1 minute.		  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once PRN	Start: S					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.
				Day 4	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 5	Interval: --	Occurrences: --			Vitals
  	VITAL SIGNS - T/P/R/BP PER UNIT PROTOCOL	Interval: --	Occurrences: --	Comments:	Obtain Height with first visit; Weight with every visit. 
Monitor BP, HR, Temp, RR with Every visit.
			Pre-Medications
  	INV amlodipine 10 mg tablet (PRO00011685/Niravath)	Dose: --	Route: oral	daily for 6 doses			Offset: 0 Hours	Instructions:	Take one tablet by mouth at least 30 minutes PRIOR to L-NMMA infusion, as instructed by the research staff. To be started 24 hours prior to L-NMMA infusion and then daily on days of L-NMMA infusion. Hold for SBP less than 100 mmHg.			Vitals
  	VITAL SIGNS - T/P/R/BP PER UNIT PROTOCOL	Interval: --	Occurrences: --	Comments:	Blood Pressure must be monitored every 30 minutes during L-NMMA Infusion.  Patient should also be monitored for 30 minutes post-infusion

If Systolic BP GREATER than 180 mm Hg, STOP Infusion.  Recheck in 30 minutes.
If Systolic BP DECREASES to LESS than 160 mm Hg, Restart Infusion.  
If Still GREATER than 160 mm Hg, Recheck in 15-30 minutes.
If Systolic BP GREATER than 160 mm Hg a Second Time, Discontinue Infusion and Contact MD and Research Coordinator.
If Infusion is Restarted and Systolic BP Increases to GREATER than 180 mm Hg a second time, Discontinue Infusion and Contact MD and Research Coordinator.
			Biologicals
  	INV L-NMMA (PRO00011685/Niravath) IVPB in sodium chloride 0.9%	Dose: --	Route: intravenous	once over 2 Hours for 1 dose			Offset: 0 Hours	Instructions:	L-NMMA dosage will de-escalate/escalate based on the CRM. Contains active study drug L-NMMA in NS, total volume 100 mL. Prepared bag is stable for 4 hours when refrigerated. Infuse intravenously over 2 hours. Caution: Limited by Federal (USA) Law to Investigational Drug.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV L-NMMA (PRO00011685/NIRAVATH) VIAL	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes				Emergency Medications
  	ONC NURSING COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	Notify covering provider of reaction and symptoms.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once PRN				Instructions:	May repeat once after 15 minutes if needed. If given IV, administer 25 mg over 1 minute or 50 mg over 2 minutes.		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once PRN				Instructions:	If given IV, administer 25 mg over 1 minute or 50 mg over 2 minutes.		  	dexAMETHasone (DECADRON) IV 10 mg	Dose: 10 mg	Route: intravenous	once PRN	Start: S			Instructions:	Administer over 1 minute.		  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once PRN	Start: S					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.
				Day 5	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 5	Interval: --	Occurrences: --			Vitals
  	VITAL SIGNS - T/P/R/BP PER UNIT PROTOCOL	Interval: --	Occurrences: --	Comments:	Obtain Height with first visit; Weight with every visit. 
Monitor BP, HR, Temp, RR with Every visit.
			Pre-Medications
  	INV amlodipine 10 mg tablet (PRO00011685/Niravath)	Dose: --	Route: oral	daily for 6 doses			Offset: 0 Hours	Instructions:	Take one tablet by mouth at least 30 minutes PRIOR to L-NMMA infusion, as instructed by the research staff. To be started 24 hours prior to L-NMMA infusion and then daily on days of L-NMMA infusion. Hold for SBP less than 100 mmHg.			Vitals
  	VITAL SIGNS - T/P/R/BP PER UNIT PROTOCOL	Interval: --	Occurrences: --	Comments:	Blood Pressure must be monitored every 30 minutes during L-NMMA Infusion.  Patient should also be monitored for 30 minutes post-infusion

If Systolic BP GREATER than 180 mm Hg, STOP Infusion.  Recheck in 30 minutes.
If Systolic BP DECREASES to LESS than 160 mm Hg, Restart Infusion.  
If Still GREATER than 160 mm Hg, Recheck in 15-30 minutes.
If Systolic BP GREATER than 160 mm Hg a Second Time, Discontinue Infusion and Contact MD and Research Coordinator.
If Infusion is Restarted and Systolic BP Increases to GREATER than 180 mm Hg a second time, Discontinue Infusion and Contact MD and Research Coordinator.
			Biologicals
  	INV L-NMMA (PRO00011685/Niravath) IVPB in sodium chloride 0.9%	Dose: --	Route: intravenous	once over 2 Hours for 1 dose			Offset: 0 Hours	Instructions:	L-NMMA dosage will de-escalate/escalate based on the CRM. Contains active study drug L-NMMA in NS, total volume 100 mL. Prepared bag is stable for 4 hours when refrigerated. Infuse intravenously over 2 hours. Caution: Limited by Federal (USA) Law to Investigational Drug.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV L-NMMA (PRO00011685/NIRAVATH) VIAL	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes				Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Emergency Medications
  	ONC NURSING COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	Notify covering provider of reaction and symptoms.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once PRN				Instructions:	May repeat once after 15 minutes if needed. If given IV, administer 25 mg over 1 minute or 50 mg over 2 minutes.		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once PRN				Instructions:	If given IV, administer 25 mg over 1 minute or 50 mg over 2 minutes.		  	dexAMETHasone (DECADRON) IV 10 mg	Dose: 10 mg	Route: intravenous	once PRN	Start: S			Instructions:	Administer over 1 minute.		  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once PRN	Start: S					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.
					
Cycle 6	Repeat 1 time	Cycle length: 21 days	Day 0	Perform every 1 day x1		Vitals
  	VITAL SIGNS - T/P/R/BP PER UNIT PROTOCOL	Interval: --	Occurrences: --	Comments:	Obtain Height with first visit; Weight with every visit. 
Monitor BP, HR, Temp, RR with Every visit.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	URIC ACID LEVEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --			Pre-Medications
  	INV amlodipine 10 mg tablet, PRO00011685/Niravath, 10 mg	Dose: --	Route: oral	daily	Dispense: --	Refills: --	Start: S	End: S+6		Instructions:	Start taking 24 hours PRIOR to the Day 1 L-NMMA Infusion.  Bring to infusion appointment.  Take at least 30 minutes PRIOR to L-NMMA Infusion on Days 1 through 5			Pre-Medications
  	dexamethasone (DECADRON) 4 MG tablet	Dose: 8 mg	Route: oral	daily	Dispense: 6 tablet	Refills: --	Start: S	End: S+3		Instructions:	Take the day before, the day of, and the day after DOCEtaxel infusion.				Prior to each Cycle	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 8	Interval: --	Occurrences: --			Vitals
  	VITAL SIGNS - T/P/R/BP PER UNIT PROTOCOL	Interval: --	Occurrences: --	Comments:	Obtain Height with first visit; Weight with every visit. 
Monitor BP, HR, Temp, RR with Every visit.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Pre-Medications
  	INV amlodipine 10 mg tablet (PRO00011685/Niravath)	Dose: --	Route: oral	daily for 6 doses			Offset: 0 Hours	Instructions:	Take one tablet by mouth at least 30 minutes PRIOR to L-NMMA infusion, as instructed by the research staff. To be started 24 hours prior to L-NMMA infusion and then daily on days of L-NMMA infusion. Hold for SBP less than 100 mmHg.			Vitals
  	VITAL SIGNS - T/P/R/BP PER UNIT PROTOCOL	Interval: --	Occurrences: --	Comments:	Blood Pressure must be monitored every 30 minutes during L-NMMA Infusion.  Patient should also be monitored for 30 minutes post-infusion

If Systolic BP GREATER than 180 mm Hg, STOP Infusion.  Recheck in 30 minutes.
If Systolic BP DECREASES to LESS than 160 mm Hg, Restart Infusion.  
If Still GREATER than 160 mm Hg, Recheck in 15-30 minutes.
If Systolic BP GREATER than 160 mm Hg a Second Time, Discontinue Infusion and Contact MD and Research Coordinator.
If Infusion is Restarted and Systolic BP Increases to GREATER than 180 mm Hg a second time, Discontinue Infusion and Contact MD and Research Coordinator.
			Biologicals
  	INV L-NMMA (PRO00011685/Niravath) IVPB in sodium chloride 0.9%	Dose: --	Route: intravenous	once over 2 Hours for 1 dose			Offset: 0 Hours	Instructions:	L-NMMA dosage will de-escalate/escalate based on the CRM. Contains active study drug L-NMMA in NS, total volume 100 mL. Prepared bag is stable for 4 hours when refrigerated. Infuse intravenously over 2 hours. Caution: Limited by Federal (USA) Law to Investigational Drug.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV L-NMMA (PRO00011685/NIRAVATH) VIAL	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes				Pre-Medications
  	ondansetron (ZOFRAN) IV 16 mg	Dose: 16 mg	Route: intravenous	once for 1 dose			Offset: 2 Hours			Antiemetics
  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 2.25 Hours			Chemotherapy
  	DOCEtaxel (TAXOTERE) 75 mg/m2 in sodium chloride (NON-PVC) 0.9 % 250 mL chemo IVPB	Dose: 75 mg/m2	Route: intravenous	once over 60 Minutes for 1 dose			Offset: 2.75 Hours	Instructions:	Administer through non-DEHP tubing; Use within 4 hours of preparation; Protect from light. Administer over 1 hour (+/- 10 minutes).	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	DOCETAXEL 80 MG/4 ML (20 MG/ML) INTRAVENOUS SOLUTION	Medications	75 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % IV SOLP (EXCEL;NON-PVC)	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) IV SOLP (EXCEL; NON-PVC)	QS Base	250 mL	No	Yes				Emergency Medications
  	ONC NURSING COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	Notify covering provider of reaction and symptoms.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once PRN				Instructions:	May repeat once after 15 minutes if needed. If given IV, administer 25 mg over 1 minute or 50 mg over 2 minutes.		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once PRN				Instructions:	If given IV, administer 25 mg over 1 minute or 50 mg over 2 minutes.		  	dexAMETHasone (DECADRON) IV 10 mg	Dose: 10 mg	Route: intravenous	once PRN	Start: S			Instructions:	Administer over 1 minute.		  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once PRN	Start: S					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.
				Day 2	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 5	Interval: --	Occurrences: --			Vitals
  	VITAL SIGNS - T/P/R/BP PER UNIT PROTOCOL	Interval: --	Occurrences: --	Comments:	Obtain Height with first visit; Weight with every visit. 
Monitor BP, HR, Temp, RR with Every visit.
			Pre-Medications
  	INV amlodipine 10 mg tablet (PRO00011685/Niravath)	Dose: --	Route: oral	daily for 6 doses			Offset: 0 Hours	Instructions:	Take one tablet by mouth at least 30 minutes PRIOR to L-NMMA infusion, as instructed by the research staff. To be started 24 hours prior to L-NMMA infusion and then daily on days of L-NMMA infusion. Hold for SBP less than 100 mmHg.			Vitals
  	VITAL SIGNS - T/P/R/BP PER UNIT PROTOCOL	Interval: --	Occurrences: --	Comments:	Blood Pressure must be monitored every 30 minutes during L-NMMA Infusion.  Patient should also be monitored for 30 minutes post-infusion

If Systolic BP GREATER than 180 mm Hg, STOP Infusion.  Recheck in 30 minutes.
If Systolic BP DECREASES to LESS than 160 mm Hg, Restart Infusion.  
If Still GREATER than 160 mm Hg, Recheck in 15-30 minutes.
If Systolic BP GREATER than 160 mm Hg a Second Time, Discontinue Infusion and Contact MD and Research Coordinator.
If Infusion is Restarted and Systolic BP Increases to GREATER than 180 mm Hg a second time, Discontinue Infusion and Contact MD and Research Coordinator.
			Biologicals
  	INV L-NMMA (PRO00011685/Niravath) IVPB in sodium chloride 0.9%	Dose: --	Route: intravenous	once over 2 Hours for 1 dose			Offset: 0 Hours	Instructions:	L-NMMA dosage will de-escalate/escalate based on the CRM. Contains active study drug L-NMMA in NS, total volume 100 mL. Prepared bag is stable for 4 hours when refrigerated. Infuse intravenously over 2 hours. Caution: Limited by Federal (USA) Law to Investigational Drug.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV L-NMMA (PRO00011685/NIRAVATH) VIAL	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes				Emergency Medications
  	ONC NURSING COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	Notify covering provider of reaction and symptoms.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once PRN				Instructions:	May repeat once after 15 minutes if needed. If given IV, administer 25 mg over 1 minute or 50 mg over 2 minutes.		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once PRN				Instructions:	If given IV, administer 25 mg over 1 minute or 50 mg over 2 minutes.		  	dexAMETHasone (DECADRON) IV 10 mg	Dose: 10 mg	Route: intravenous	once PRN	Start: S			Instructions:	Administer over 1 minute.		  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once PRN	Start: S					Supportive Care
  	pegfilgrastim (NEULASTA) on-body injection kit 6 mg	Dose: 6 mg	Route: subcutaneous	once for 1 dose				Instructions:	To inject at least 24 hours after chemotherapy complete.			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.
				Day 3	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 5	Interval: --	Occurrences: --			Vitals
  	VITAL SIGNS - T/P/R/BP PER UNIT PROTOCOL	Interval: --	Occurrences: --	Comments:	Obtain Height with first visit; Weight with every visit. 
Monitor BP, HR, Temp, RR with Every visit.
			Pre-Medications
  	INV amlodipine 10 mg tablet (PRO00011685/Niravath)	Dose: --	Route: oral	daily for 6 doses			Offset: 0 Hours	Instructions:	Take one tablet by mouth at least 30 minutes PRIOR to L-NMMA infusion, as instructed by the research staff. To be started 24 hours prior to L-NMMA infusion and then daily on days of L-NMMA infusion. Hold for SBP less than 100 mmHg.			Vitals
  	VITAL SIGNS - T/P/R/BP PER UNIT PROTOCOL	Interval: --	Occurrences: --	Comments:	Blood Pressure must be monitored every 30 minutes during L-NMMA Infusion.  Patient should also be monitored for 30 minutes post-infusion

If Systolic BP GREATER than 180 mm Hg, STOP Infusion.  Recheck in 30 minutes.
If Systolic BP DECREASES to LESS than 160 mm Hg, Restart Infusion.  
If Still GREATER than 160 mm Hg, Recheck in 15-30 minutes.
If Systolic BP GREATER than 160 mm Hg a Second Time, Discontinue Infusion and Contact MD and Research Coordinator.
If Infusion is Restarted and Systolic BP Increases to GREATER than 180 mm Hg a second time, Discontinue Infusion and Contact MD and Research Coordinator.
			Biologicals
  	INV L-NMMA (PRO00011685/Niravath) IVPB in sodium chloride 0.9%	Dose: --	Route: intravenous	once over 2 Hours for 1 dose			Offset: 0 Hours	Instructions:	L-NMMA dosage will de-escalate/escalate based on the CRM. Contains active study drug L-NMMA in NS, total volume 100 mL. Prepared bag is stable for 4 hours when refrigerated. Infuse intravenously over 2 hours. Caution: Limited by Federal (USA) Law to Investigational Drug.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV L-NMMA (PRO00011685/NIRAVATH) VIAL	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes				Emergency Medications
  	ONC NURSING COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	Notify covering provider of reaction and symptoms.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once PRN				Instructions:	May repeat once after 15 minutes if needed. If given IV, administer 25 mg over 1 minute or 50 mg over 2 minutes.		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once PRN				Instructions:	If given IV, administer 25 mg over 1 minute or 50 mg over 2 minutes.		  	dexAMETHasone (DECADRON) IV 10 mg	Dose: 10 mg	Route: intravenous	once PRN	Start: S			Instructions:	Administer over 1 minute.		  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once PRN	Start: S					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.
				Day 4	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 5	Interval: --	Occurrences: --			Vitals
  	VITAL SIGNS - T/P/R/BP PER UNIT PROTOCOL	Interval: --	Occurrences: --	Comments:	Obtain Height with first visit; Weight with every visit. 
Monitor BP, HR, Temp, RR with Every visit.
			Pre-Medications
  	INV amlodipine 10 mg tablet (PRO00011685/Niravath)	Dose: --	Route: oral	daily for 6 doses			Offset: 0 Hours	Instructions:	Take one tablet by mouth at least 30 minutes PRIOR to L-NMMA infusion, as instructed by the research staff. To be started 24 hours prior to L-NMMA infusion and then daily on days of L-NMMA infusion. Hold for SBP less than 100 mmHg.			Vitals
  	VITAL SIGNS - T/P/R/BP PER UNIT PROTOCOL	Interval: --	Occurrences: --	Comments:	Blood Pressure must be monitored every 30 minutes during L-NMMA Infusion.  Patient should also be monitored for 30 minutes post-infusion

If Systolic BP GREATER than 180 mm Hg, STOP Infusion.  Recheck in 30 minutes.
If Systolic BP DECREASES to LESS than 160 mm Hg, Restart Infusion.  
If Still GREATER than 160 mm Hg, Recheck in 15-30 minutes.
If Systolic BP GREATER than 160 mm Hg a Second Time, Discontinue Infusion and Contact MD and Research Coordinator.
If Infusion is Restarted and Systolic BP Increases to GREATER than 180 mm Hg a second time, Discontinue Infusion and Contact MD and Research Coordinator.
			Biologicals
  	INV L-NMMA (PRO00011685/Niravath) IVPB in sodium chloride 0.9%	Dose: --	Route: intravenous	once over 2 Hours for 1 dose			Offset: 0 Hours	Instructions:	L-NMMA dosage will de-escalate/escalate based on the CRM. Contains active study drug L-NMMA in NS, total volume 100 mL. Prepared bag is stable for 4 hours when refrigerated. Infuse intravenously over 2 hours. Caution: Limited by Federal (USA) Law to Investigational Drug.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV L-NMMA (PRO00011685/NIRAVATH) VIAL	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes				Emergency Medications
  	ONC NURSING COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	Notify covering provider of reaction and symptoms.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once PRN				Instructions:	May repeat once after 15 minutes if needed. If given IV, administer 25 mg over 1 minute or 50 mg over 2 minutes.		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once PRN				Instructions:	If given IV, administer 25 mg over 1 minute or 50 mg over 2 minutes.		  	dexAMETHasone (DECADRON) IV 10 mg	Dose: 10 mg	Route: intravenous	once PRN	Start: S			Instructions:	Administer over 1 minute.		  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once PRN	Start: S					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.
				Day 5	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 5	Interval: --	Occurrences: --			Vitals
  	VITAL SIGNS - T/P/R/BP PER UNIT PROTOCOL	Interval: --	Occurrences: --	Comments:	Obtain Height with first visit; Weight with every visit. 
Monitor BP, HR, Temp, RR with Every visit.
			Pre-Medications
  	INV amlodipine 10 mg tablet (PRO00011685/Niravath)	Dose: --	Route: oral	daily for 6 doses			Offset: 0 Hours	Instructions:	Take one tablet by mouth at least 30 minutes PRIOR to L-NMMA infusion, as instructed by the research staff. To be started 24 hours prior to L-NMMA infusion and then daily on days of L-NMMA infusion. Hold for SBP less than 100 mmHg.			Vitals
  	VITAL SIGNS - T/P/R/BP PER UNIT PROTOCOL	Interval: --	Occurrences: --	Comments:	Blood Pressure must be monitored every 30 minutes during L-NMMA Infusion.  Patient should also be monitored for 30 minutes post-infusion

If Systolic BP GREATER than 180 mm Hg, STOP Infusion.  Recheck in 30 minutes.
If Systolic BP DECREASES to LESS than 160 mm Hg, Restart Infusion.  
If Still GREATER than 160 mm Hg, Recheck in 15-30 minutes.
If Systolic BP GREATER than 160 mm Hg a Second Time, Discontinue Infusion and Contact MD and Research Coordinator.
If Infusion is Restarted and Systolic BP Increases to GREATER than 180 mm Hg a second time, Discontinue Infusion and Contact MD and Research Coordinator.
			Biologicals
  	INV L-NMMA (PRO00011685/Niravath) IVPB in sodium chloride 0.9%	Dose: --	Route: intravenous	once over 2 Hours for 1 dose			Offset: 0 Hours	Instructions:	L-NMMA dosage will de-escalate/escalate based on the CRM. Contains active study drug L-NMMA in NS, total volume 100 mL. Prepared bag is stable for 4 hours when refrigerated. Infuse intravenously over 2 hours. Caution: Limited by Federal (USA) Law to Investigational Drug.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV L-NMMA (PRO00011685/NIRAVATH) VIAL	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes				Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Emergency Medications
  	ONC NURSING COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	Notify covering provider of reaction and symptoms.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once PRN				Instructions:	May repeat once after 15 minutes if needed. If given IV, administer 25 mg over 1 minute or 50 mg over 2 minutes.		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once PRN				Instructions:	If given IV, administer 25 mg over 1 minute or 50 mg over 2 minutes.		  	dexAMETHasone (DECADRON) IV 10 mg	Dose: 10 mg	Route: intravenous	once PRN	Start: S			Instructions:	Administer over 1 minute.		  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once PRN	Start: S					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.
					
End of Treatment 	Repeat 1 time	Cycle length: 1 day	EOT	Perform every 1 day x1