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IP PRO00037588 IOV-GM1-201 GANGULY	

Types:      Research Oncology Treatment
Synonyms:  

Take Home Medications	Repeat 1 time	Cycle length: 1 day	Prescription	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   IOV-GM1-201 Protocol v2 Amendment v1_18Mar2022.pdf
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Autologous TIL regimen Treatment :  Refer to Section 6.1.4 Protocol Access Hyperlink:   IOV-GM1-201 Protocol v2 Amendment v1_18Mar2022.pdf
			Take-Home Medications
  	sulfamethoxazole-trimethoprim (Bactrim DS) 800-160 mg per tablet	Dose: 1 tablet	Route: oral	3 times weekly	Dispense: 12 tablet	Refills: 5	Start: S			Instructions:	Take on Monday, Wednesday, and Friday.		  	valACYclovir (Valtrex) 500 MG tablet	Dose: 500 mg	Route: oral	2 times daily	Dispense: 60 tablet	Refills: 2	Start: S							
Pre-Transplant	Repeat 1 time	Cycle length: 5 days	Day -5	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   IOV-GM1-201 Protocol v2 Amendment v1_18Mar2022.pdf
		  	ONC PROVIDER COMMUNICATION 2	Interval: Until discontinued	Occurrences: --	Comments:	Dose Modifications and Management for Autologous TIL regimen Treatment :  Refer to Section 6.1.4 Protocol Access Hyperlink:   IOV-GM1-201 Protocol v2 Amendment  v1_18Mar2022.pdf
			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: Until discontinued	Occurrences: --	Comments:	o Antibacterial prophylaxis should be started when ANC LESS than 500 and continued until ANC GREATER than 500. 
o Continue antifungal prophylaxis until ANC GREATER than 1000.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: Once	Occurrences: --	Comments:	Physical examination - 
o On dosing days, this assessment will be performed prior to administration of the study intervention and will be symptom-directed. Clinically significant worsening must be recorded as AEs. 
o Body surface area (BSA) and body mass index (BMI) will be calculated at Day -5 only or within 24 hours of start of NMALD. 
o Weight measurement on Days -4 through -1 is only required if there is a concern of > 10% change from Day -5. Weight is also measured on Day 0 (or per institutional guidelines) to determine the IL-2 dose. 
(X) = Optional assessment to be performed at Day 4, only when the last dose of IL-2 falls on Day 4.
		  	ONC NURSING COMMUNICATION 11	Interval: Once	Occurrences: --	Comments:	ECOG performance status - On dosing days, this assessment will be performed prior to administration of the study intervention
			Nursing Orders
  	ONC NURSING COMMUNICATION 25	Interval: Until discontinued	Occurrences: --	Comments:	Record details of any hospitalization(s) - 
o Performed continuously. 
o For each hospitalization, the date of admission, date of discharge, the hospital unit, and reason for hospitalization will be recorded. Participants must be hospitalized on the day of the planned IOV-4001 infusion (Day 0). They will remain hospitalized until completion of the IL-2 administration or longer, as per institutional standards
		  	ONC NURSING COMMUNICATION 32	Interval: Until discontinued	Occurrences: --	Comments:	AE Collection - 
o Performed continuously. 
o All AEs and SAEs will be collected until 30 days after Day 0 and will be assessed as per the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCICTCAE). See Section 8.4 and Appendix 3 (Section 10.3) for more details. For the DLT evaluable participants, the DLT observation period will begin on Day 0 and continue for 28 days. See Section 5.5.1 for more details.
		  	ONC NURSING COMMUNICATION 14	Interval: Until discontinued	Occurrences: --	Comments:	Record use of prior or concomitant medications - 
o Performed continuously. 
o All medications, therapies, or interventions received by the participant must be recorded. See Section 6.8 for more details
		  	ONC NURSING COMMUNICATION 33	Interval: Until discontinued	Occurrences: --	Comments:	Infectious disease prophylaxis - 
o Performed continuously. 
o Includes prophylaxis for Pneumocystis jirovecii pneumonia, fungal infection, herpes simplex virus (HSV), varicella, and bacterial infections. See Section 6.8.2.2 for more details.
		  	ONC NURSING COMMUNICATION 34	Interval: Until discontinued	Occurrences: --	Comments:	Infection management - 
o Performed continuously. 
o See Section 6.8.2.3 for more details.
		  	VITAL SIGNS - T/P/R/BP	Interval: Per unit protocol	Occurrences: --	Comments:	On dosing days, this assessment will be performed prior to
administration of the study intervention. Includes pulse
rate, respiratory rate, systolic and diastolic blood pressure, and temperature. Pulse oximetry should also be monitored as per
institutional standard. On Day 0, vital signs will be monitored as per institutional standard or at least every 30 min (± 5 min) during infusion, then hourly (± 15 min) for 4 hours and
then routinely (at least every 4 to 6 hours), unless otherwise clinically indicated, for up to approximately 24 hours after the IOV-4001 infusion. If IL-2 dosing ends on Day 3, the Day 4 vital signs assessment is not required.
			Labs
  	ECG 12-LEAD	Interval: Daily	Occurrences: --	Comments:	o To be performed on days -5 and -4. 
o MUST be reviewed by a physician daily prior to each cyclophosphamide dose.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Daily	Occurrences: --	Comments:	On dosing days, this assessment will be performed prior to administration of study intervention. If IL-2 dosing ends on Day 3, the Day 4 testing is not required. Must also be completed on the last day of hospitalization or on Day 14, whichever occurs first.
See Section 8.3.7 and Appendix 2 (Section 10.2) for more details
		  	COMPREHENSIVE METABOLIC PANEL	Interval: Daily	Occurrences: --	Comments:	On dosing days, this assessment will be performed prior to administration of study intervention. If IL-2 dosing ends on Day 3, the Day 4 testing is not required. Must also be completed on the last day of hospitalization or on Day 14, whichever occurs first.
See Section 8.3.7 and Appendix 2 (Section 10.2) for more details
		  	MAGNESIUM LEVEL	Interval: Daily	Occurrences: --	Comments:	On dosing days, this assessment will be performed prior to administration of study intervention. If IL-2 dosing ends on Day 3, the Day 4 testing is not required. Must also be completed on the last day of hospitalization or on Day 14, whichever occurs first.
See Section 8.3.7 and Appendix 2 (Section 10.2) for more details
		  	PHOSPHORUS LEVEL	Interval: Daily	Occurrences: --	Comments:	On dosing days, this assessment will be performed prior to administration of study intervention. If IL-2 dosing ends on Day 3, the Day 4 testing is not required. Must also be completed on the last day of hospitalization or on Day 14, whichever occurs first.
See Section 8.3.7 and Appendix 2 (Section 10.2) for more details
		  	LDH	Interval: Daily	Occurrences: --	Comments:	On dosing days, this assessment will be performed prior to administration of study intervention. If IL-2 dosing ends on Day 3, the Day 4 testing is not required. Must also be completed on the last day of hospitalization or on Day 14, whichever occurs first.
See Section 8.3.7 and Appendix 2 (Section 10.2) for more details
		  	CREATINE KINASE, TOTAL (CPK)	Interval: Daily	Occurrences: --	Comments:	On dosing days, this assessment will be performed prior to administration of study intervention. If IL-2 dosing ends on Day 3, the Day 4 testing is not required. Must also be completed on the last day of hospitalization or on Day 14, whichever occurs first.
See Section 8.3.7 and Appendix 2 (Section 10.2) for more details
		  	URIC ACID LEVEL	Interval: Daily	Occurrences: --	Comments:	On dosing days, this assessment will be performed prior to administration of study intervention. If IL-2 dosing ends on Day 3, the Day 4 testing is not required. Must also be completed on the last day of hospitalization or on Day 14, whichever occurs first.
See Section 8.3.7 and Appendix 2 (Section 10.2) for more details
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: Daily	Occurrences: --			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: Once	Occurrences: --	Comments:	Will be performed for all WOCBP prior to initiation of the NMA-LD (Day -5), at the End-of-treatment Visit, and any other time clinically indicated. If pregnancy is discovered at any point in time during the study, it must be reported immediately
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --	Comments:	A Day 0 blood draw should be performed prior to the TIL infusion The next blood draw should be performed following the TIL infusion but prior to the first IL-2 infusion.
A Day 3/4 blood draw should be performed after the last dose of IL-2 but not before Day 3. The Day -5 blood draw should be performed prior to NMA-LD. See the Laboratory Manual for more details
			Nursing Orders
  	ONC NURSING COMMUNICATION 36	Interval: Until discontinued	Occurrences: --	Comments:	Sequence of admin of NMA-LD: Mesna bolus, then Cyclophosphamide then Fludarabine, then mesna
			Nursing Orders
  	ONC NURSING COMMUNICATION 38	Interval: Until discontinued	Occurrences: --	Comments:	During Cyclophosphamide:
1. 12 lead EKG must be ordered and reviewed by physician prior to each dose.
2. Starting 4 hours prior to cyclophosphamide, start Normal Saline at 125 mL/hr and continue for 24 hours after the last dose of cyclophosphamide finishes (Max total volume infusion rate during chemotherapy = 350 mL/hr)
3. Urinaysis daily x 4 days
4. Instruct patient to void every 1-2 hours (while awake) daily for 3 days
			Hydration
  	sodium chloride 0.9 % infusion	Dose: 125 mL/hr	Route: intravenous	continuous	Start: S	End: S+3		Instructions:	4 hours PRIOR to cyclophosphamide, start Normal Saline at 125 mL/hr and continue for 24 hours AFTER the last dose of cyclophosphamide finishes (Max total volume infusion rate during chemotherapy = 350 mL/hr).			Pre-Medications
  	ondansetron (ZOFRAN) IV 16 mg	Dose: 16 mg	Route: intravenous	every 24 hours for 2 doses	Start: S			Instructions:	Give 30 min prior to Cyclophosphamide on day -5 and -4		  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Give 30 min prior to Cyclophosphamide on day -5		  	OLANZapine (ZYPREXA) tablet 10 mg	Dose: 10 mg	Route: oral	every 24 hours for 4 doses	Start: S			Instructions:	Give 30 min prior to chemo on days -5, -4, -3, and -2		  	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	every 24 hours	Start: S+2			Instructions:	Give 30 min prior to Fludarabine on days -3, -2, and -1		  	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	every 8 hours PRN	Start: S+2					Chemotherapy
  	mesna (MESNEX) 20 mg/kg in sodium chloride 0.9% 100 mL chemo IVPB	Dose: 20 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Give immediately PRIOR to first cyclophosamide infusion on day -5	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	MESNA 100 MG/ML INTRAVENOUS SOLUTION	Medications	20 mg/kg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes			  	INV-Cyclophosphamide (IOV-GM1-201/Pro00037588/Ganguly) 60 mg/kg in dextrose 5% 500 mL chemo IVPB	Dose: 60 mg/kg	Route: intravenous	every 24 hours over 120 Minutes for 2 doses			Offset: 30 Minutes	Instructions:	To be given on days -5 and -4	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-CYCLOPHOSPHAMIDE 1 GRAM IV POWDER FOR SOLN (IOV-GM1-201/PRO00037588/GANGULY)	Medications	60 mg/kg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	500 mL	Yes	Yes			  	ONC PROVIDER COMMUNICATION 5	Interval: Until discontinued	Occurrences: --	Comments:	Fludarabine: Dose reduction required for CrCl LESS than 79 mL/min.  Please see protocol for details.
		  	INV-Fludarabine (IOV-GM1-201/Pro00037588/Ganguly) 25 mg/m2 in sodium chloride 0.9% 100 mL chemo IVPB	Dose: 25 mg/m2	Route: intravenous	every 24 hours over 30 Minutes for 5 doses			Offset: 2.5 Hours	Instructions:	Dose reduction required for CrCl < 79 mL/min.  Please see protocol for details. 
To be given on days -5,-4,-3,-2,-1	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-FLUDARABINE 50 MG/2 ML IV SOLN (IOV-GM1-201/PRO00037588/GANGULY)	Medications	25 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes			  	mesna (MESNEX) 10 mg/kg in sodium chloride 0.9% 100 mL chemo IVPB	Dose: 10 mg/kg	Route: intravenous	every 4 hours over 30 Minutes for 12 doses			Offset: 4.5 Hours	Instructions:	Start 4 hours after loading dose of Mesna	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	MESNA 100 MG/ML INTRAVENOUS SOLUTION	Medications	10 mg/kg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes				Supportive Care
  	furosemide (LASIX) injection 20 mg	Dose: 20 mg	Route: intravenous	every 24 hours for 2 doses			Offset: 2.5 Hours	Instructions:	Give at completion of each cyclophosphamide dose on days -5 and -4		  	furosemide (LASIX) injection 20 mg	Dose: 20 mg	Route: intravenous	every 24 hours for 2 doses			Offset: 8.5 Hours	Instructions:	Give 6 hours AFTER completion of each cyclophosphamide dose on days -5 and -4			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: Until discontinued	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: Until discontinued	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: Until discontinued	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN	Start: S				  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	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.					
Transplant	Repeat 1 time	Cycle length: 15 days	Day 0	Perform every 1 day x1		Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --	Comments:	A Day 0 blood draw should be performed prior to the TIL infusion The next blood draw should be performed following the TIL infusion but prior to the first IL-2 infusion.
A Day 3/4 blood draw should be performed after the last dose of IL-2 but not before Day 3. The Day -5 blood draw should be performed prior to NMA-LD. See the Laboratory Manual for more details
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --	Comments:	A blood draw should be performed following the TIL infusion but prior to the first IL-2 infusion. A Day 3/4 blood draw should be performed after the last dose of
IL-2 but not before Day 3. 
See the Laboratory Manual for more details
			Nursing Orders
  	ONC NURSING COMMUNICATION 37	Interval: Until discontinued	Occurrences: --	Comments:	Sequence of admin day 0 and day 1: IOV-4001, then IL-2 (at least 3 hours and no later than 24 hours after last dose of IOV-4001).
			Nursing Orders
  	ONC NURSING COMMUNICATION 52	Interval: Until discontinued	Occurrences: --	Comments:	During the safety run-in, IOV-4001 will be administered in a split-dose fashion. On Day 0, between approximately 25 and 33% of the total IOV-4001 manufactured dose will be infused (ie, 1 of the total of 3 or 4 cryopreservation bags containing the IOV-4001 drug product). If the participant remains clinically stable with resolution of TEAEs related to IOV-4001 to Grade 1 or baseline (ie, the status immediately prior to the IOV-4001 infusion), within 24 hours of the infusion, the remaining approximately 67 to 75% of the total IOV-4001 dose will be infused on Day 1 with a maximum allowable delay of 48 hours from the first infusion. IL-2 dosing will then begin on Day 1 or 2 and continue until Day 4 or 5.
			Medications
  	sulfamethoxazole-trimethoprim (BACTRIM DS) 800-160 mg tablet 1 tablet	Dose: 1 tablet	Route: oral	3 times weekly	Start: S				  	valACYclovir (VALTREX) tablet 500 mg	Dose: 500 mg	Route: oral	2 times daily	Start: S				  	fluconazole (DIFLUCAN) tablet 400 mg	Dose: 400 mg	Route: oral	daily	Start: S					Pre-Medications
  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Once, 30-60 minutes before IOV-4001 infusion		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Once, 30-60 minutes before IOV-4001 infusion			Immuno-therapy
  	INV-IOV-4001 infusion (IOV-GM1-201/Pro00037588/Ganguly) 125 mL	Dose: 125 mL	Route: intravenous	every 24 hours @ 300-600 mL/hr for 2 doses			Offset: 30 Minutes	Instructions:	On day 0, administer 1 bag of IOV-4001.  If the patient remains clinically stable with resolution of TEAEs related to IOV-4001 to grade 1 or baseline within 24 hours of the infusion, give one 125mL IV bag on day 1 or day 2, then once daily until patient-specific supplied IV bags are all used. Mix gently prior to infusion. Stable for 3 hours at room temperature. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Supportive Care
  	INV-IL-2 (IOV-GM1-201/Pro00037588/Ganguly) 600,000 Units/kg in dextrose 5% 50 mL IVPB	Dose: 600,000 Units/kg	Route: intravenous	every 8 hours over 15 Minutes for 6 doses			Offset: 4 Hours	Instructions:	IL-2 dosing is initiated no sooner than 3 hours after, but no later than 24 hours after completion of IOV-4001 on day 0, then every 8-12 hours up to 6 doses.
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-IL-2 INJECTION (IOV-GM1-201/PRO00037588/GANGULY)	Medications	600,000 Units/kg	Main Ingredient	No	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes			  	ONC NURSING COMMUNICATION 53	Interval: Until discontinued	Occurrences: --	Comments:	IL-2 dosing is initiated no sooner than 3 hours after, but no later than 24 hours after, completion of the IOV-4001 infusion on Day 0 and continues approximately every 8 to 12 hours for up to 6 total doses
			Emergency Medications
  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	every 6 hours PRN	Start: S	End: S+2			  	meperidine (DEMEROL) injection 12.5 mg	Dose: 12.5 mg	Route: intravenous	every 15 min PRN for 3 doses	Start: S	End: S+2		Instructions:	If Rigors persist, please call MD		  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	once PRN	Start: S	End: S+2			  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once PRN	Start: S	End: S+2					Day 1	Perform every 1 day x1		Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: Once	Occurrences: --	Comments:	Physical examination - 
o On dosing days, this assessment will be performed prior to administration of the study intervention and will be symptom-directed. Clinically significant worsening must be recorded as AEs. 
o Body surface area (BSA) and body mass index (BMI) will be calculated at Day -5 only or within 24 hours of start of NMALD. 
o Weight measurement on Days -4 through -1 is only required if there is a concern of > 10% change from Day -5. Weight is also measured on Day 0 (or per institutional guidelines) to determine the IL-2 dose. 
(X) = Optional assessment to be performed at Day 4, only when the last dose of IL-2 falls on Day 4.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --	Comments:	A blood draw should be performed following the TIL infusion but prior to the first IL-2 infusion. A Day 3/4 blood draw should be performed after the last dose of
IL-2 but not before Day 3. 
See the Laboratory Manual for more details
			Pre-Medications
  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Once ONLY IF NEEDED for split-dose infusion, 30-60 minutes before IOV-4001 infusion		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Once ONLY IF NEEDED for split-dose infusion, 30-60 minutes before IOV-4001 infusion			Supportive Care
  	filgrastim-sndz (ZARXIO) injection solution	Dose: --	Route: subcutaneous	daily at 1600	Start: S			Instructions:	o Do not administer filgrastim-sndz within 24 hours before chemotherapy. 
o Begin on Day +1. 
o Continue until ANC GREATER than 1000 for 3 consecutive days .				Day 2	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: Once	Occurrences: --	Comments:	Physical examination - 
o On dosing days, this assessment will be performed prior to administration of the study intervention and will be symptom-directed. Clinically significant worsening must be recorded as AEs. 
o Body surface area (BSA) and body mass index (BMI) will be calculated at Day -5 only or within 24 hours of start of NMALD. 
o Weight measurement on Days -4 through -1 is only required if there is a concern of > 10% change from Day -5. Weight is also measured on Day 0 (or per institutional guidelines) to determine the IL-2 dose. 
(X) = Optional assessment to be performed at Day 4, only when the last dose of IL-2 falls on Day 4.
				Days 3,4	Perform every 1 day x2		Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: Once	Occurrences: --	Comments:	Physical examination - 
o On dosing days, this assessment will be performed prior to administration of the study intervention and will be symptom-directed. Clinically significant worsening must be recorded as AEs. 
o Body surface area (BSA) and body mass index (BMI) will be calculated at Day -5 only or within 24 hours of start of NMALD. 
o Weight measurement on Days -4 through -1 is only required if there is a concern of > 10% change from Day -5. Weight is also measured on Day 0 (or per institutional guidelines) to determine the IL-2 dose. 
(X) = Optional assessment to be performed at Day 4, only when the last dose of IL-2 falls on Day 4.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --	Comments:	A Day 0 blood draw should be performed prior to the TIL infusion The next blood draw should be performed following the TIL infusion but prior to the first IL-2 infusion.
A Day 3/4 blood draw should be performed after the last dose of IL-2 but not before Day 3. The Day -5 blood draw should be performed prior to NMA-LD. See the Laboratory Manual for more details
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --	Comments:	A blood draw should be performed following the TIL infusion but prior to the first IL-2 infusion. A Day 3/4 blood draw should be performed after the last dose of
IL-2 but not before Day 3. 
See the Laboratory Manual for more details
				Day 14	Perform every 1 day x1		Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --	Comments:	A Day 0 blood draw should be performed prior to the TIL infusion The next blood draw should be performed following the TIL infusion but prior to the first IL-2 infusion.
A Day 3/4 blood draw should be performed after the last dose of IL-2 but not before Day 3. The Day -5 blood draw should be performed prior to NMA-LD. See the Laboratory Manual for more details
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --	Comments:	A blood draw should be performed following the TIL infusion but prior to the first IL-2 infusion. A Day 3/4 blood draw should be performed after the last dose of
IL-2 but not before Day 3. 
See the Laboratory Manual for more details
					
EOT	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: Once	Occurrences: --	Comments:	Physical examination - 
o On dosing days, this assessment will be performed prior to administration of the study intervention and will be symptom-directed. Clinically significant worsening must be recorded as AEs. 
o Body surface area (BSA) and body mass index (BMI) will be calculated at Day -5 only or within 24 hours of start of NMALD. 
o Weight measurement on Days -4 through -1 is only required if there is a concern of > 10% change from Day -5. Weight is also measured on Day 0 (or per institutional guidelines) to determine the IL-2 dose. 
(X) = Optional assessment to be performed at Day 4, only when the last dose of IL-2 falls on Day 4.
		  	ONC NURSING COMMUNICATION 11	Interval: Once	Occurrences: --	Comments:	ECOG performance status - On dosing days, this assessment will be performed prior to administration of the study intervention
			Nursing Orders
  	ONC NURSING COMMUNICATION 35	Interval: Once	Occurrences: --	Comments:	Disposition information - Disposition information will be recorded indicating completion of the Treatment Period or the reason, if applicable, for early discontinuation of the autologous TIL regimen  (see Section 7.1)
			Labs
  	THYROID STIMULATING HORMONE	Interval: Once	Occurrences: --	Comments:	See Section 8.3.7 and Appendix 2 (Section 10.2) for more details.
		  	T4, FREE	Interval: Once	Occurrences: --	Comments:	See Section 8.3.7 and Appendix 2 (Section 10.2) for more details.
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: Once	Occurrences: --	Comments:	Will be performed for all WOCBP prior to initiation of the NMA-LD (Day -5), at the End-of-treatment Visit, and any other time clinically indicated. If pregnancy is discovered at any point in time during the study, it must be reported immediately