Protocol Index	

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OP RSH PRO00037447 BN22-001 SBRT TEH TREATMENT ARM	

Types:      Research Oncology Treatment
Synonyms:  BRAIN META, METASTASIS, PRO00037447, BN22-001, SBRT, GAMMA KNIFE STEREOTACTIC RADIOSURGERY, HMCC-HS-GKR

Pre-therapy	Repeat 1 time	Cycle length: 1 day	Day 1	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:   HMCC-HN22-001_Teh_GammaKnife_NotIRBApproved
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	M0D0: Non-invasive stereotactic radiosurgery day 
Pre- Therapy: Any time before Systemic therapy begins.
M1D1: 1 month after initial systemic therapy 
EOT: 24 months
Safety FUP: 30 days after the last dose of trial treatment or before the initiation of a new anticancer treatment.
			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Physical exam will be performed at screening/baseline, at each post-treatment follow-up visit and at EOT (24 months). Physical exam will include vital sign (blood pressure, oral or temporal temperature, pulse, and respiratory rate) and weight measurements
			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Prior/concomitant Medications 

All concomitant medications received within 28 days before the start of trial treatment and 30 days after the last dose of trial treatment should be recorded. 
If changes occur during the trial period, documentation of drug dosage, frequency, route, and date may also be included in the CRF.
			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	SignateraTM Blood Collection (ctDNA Measurement) 

Blood collection for ctDNA measurement (SignateraTM ) will be performed at baseline, after HS-GKRS and before the start of systemic therapy, at one month after the start of therapy and every six months  thereafter. Blood sample collection will be in 4 Streck tubes (equivalent to 40mL of blood or 20mL plasma). Plasma and buffy coat will be separated within 2 hours of collection. After processing, samples will be stored at -80oC for ctDNA analysis in Dr. Jenny Chang's laboratory.
			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	AEs and SAEs will be captured from the time of HS-GKRS up to the end of the safety follow-up period.
			Labs
☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	CBC with platelet count and differential WBC count will be performed at screening, baseline, at post-treatment follow-up visits and when clinically indicated. 
		☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Clinical chemistry panel (glucose, albumin, sodium, potassium, carbon dioxide, calcium, chloride, BUN, creatinine, total protein, total bilirubin, ALP, ALT, and AST) and evaluation of magnesium, uric acid, and LDH will be performed at screening, baseline, at post-treatment follow-up visits and when clinically indicated
		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Clinical chemistry panel (glucose, albumin, sodium, potassium, carbon dioxide, calcium, chloride, BUN, creatinine, total protein, total bilirubin, ALP, ALT, and AST) and evaluation of magnesium, uric acid, and LDH will be performed at screening, baseline, at each study visit and when clinically indicated. 
		☑	URIC ACID LEVEL	Interval: --	Occurrences: --	Comments:	Clinical chemistry panel (glucose, albumin, sodium, potassium, carbon dioxide, calcium, chloride, BUN, creatinine, total protein, total bilirubin, ALP, ALT, and AST) and evaluation of magnesium, uric acid, and LDH will be performed at screening, baseline, at each study visit and when clinically indicated. 
		☑	LDH	Interval: --	Occurrences: --	Comments:	Clinical chemistry panel (glucose, albumin, sodium, potassium, carbon dioxide, calcium, chloride, BUN, creatinine, total protein, total bilirubin, ALP, ALT, and AST) and evaluation of magnesium, uric acid, and LDH will be performed at screening, baseline, at each study visit and when clinically indicated. 
					
M0D0	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Prior/concomitant Medications 

All concomitant medications received within 28 days before the start of trial treatment and 30 days after the last dose of trial treatment should be recorded. 
If changes occur during the trial period, documentation of drug dosage, frequency, route, and date may also be included in the CRF.
			Nursing Orders
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Non-invasive stereotactic radiosurgery with hippocampal sparing using the Leksell Gamma Knife instrument with precisely focused beams of radiation to target lesions in the brain will be performed at Day 0. 
			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	AEs and SAEs will be captured from the time of HS-GKRS up to the end of the safety follow-up period.
					
M1D1	Repeat 1 time	Cycle length: 168 days	Day 1	Perform every 168 days x1		Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Physical exam will be performed at screening/baseline, at each post-treatment follow-up visit and at EOT (24 months). Physical exam will include vital sign (blood pressure, oral or temporal temperature, pulse, and respiratory rate) and weight measurements
			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	RBANS Cognitive Test
			Imaging
  	MRI BRAIN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Brain MRI without and with contrast, which includes high-resolution pre- and postcontrast 3D T1 BRAVO/MPRAGE, T1 subtraction map, and T2 CUBE/SPACE will be performed at baseline, one month after HS-GKRS, every six months thereafter and at EOT.
			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	SignateraTM Blood Collection (ctDNA Measurement) 

Blood collection for ctDNA measurement (SignateraTM ) will be performed at baseline, after HS-GKRS and before the start of systemic therapy, at one month after the start of therapy and every six months  thereafter. Blood sample collection will be in 4 Streck tubes (equivalent to 40mL of blood or 20mL plasma). Plasma and buffy coat will be separated within 2 hours of collection. After processing, samples will be stored at -80oC for ctDNA analysis in Dr. Jenny Chang's laboratory.
			Labs
☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	CBC with platelet count and differential WBC count will be performed at screening, baseline, at post-treatment follow-up visits and when clinically indicated. 
		☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Clinical chemistry panel (glucose, albumin, sodium, potassium, carbon dioxide, calcium, chloride, BUN, creatinine, total protein, total bilirubin, ALP, ALT, and AST) and evaluation of magnesium, uric acid, and LDH will be performed at screening, baseline, at post-treatment follow-up visits and when clinically indicated
		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Clinical chemistry panel (glucose, albumin, sodium, potassium, carbon dioxide, calcium, chloride, BUN, creatinine, total protein, total bilirubin, ALP, ALT, and AST) and evaluation of magnesium, uric acid, and LDH will be performed at screening, baseline, at each study visit and when clinically indicated. 
		☑	URIC ACID LEVEL	Interval: --	Occurrences: --	Comments:	Clinical chemistry panel (glucose, albumin, sodium, potassium, carbon dioxide, calcium, chloride, BUN, creatinine, total protein, total bilirubin, ALP, ALT, and AST) and evaluation of magnesium, uric acid, and LDH will be performed at screening, baseline, at each study visit and when clinically indicated. 
		☑	LDH	Interval: --	Occurrences: --	Comments:	Clinical chemistry panel (glucose, albumin, sodium, potassium, carbon dioxide, calcium, chloride, BUN, creatinine, total protein, total bilirubin, ALP, ALT, and AST) and evaluation of magnesium, uric acid, and LDH will be performed at screening, baseline, at each study visit and when clinically indicated. 
			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Prior /concomitant Medications 

All concomitant medications will be recorded on the CRF including all prescription, over the counter, and IV medications and fluids. All concomitant medications received within 28 days before the start of trial treatment and 30 days after the last dose of trial treatment should be recorded.
			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	AEs and SAEs will be captured from the time of HS-GKRS up to the end of the safety follow-up period.
					
M6D1	Repeat 1 time	Cycle length: 168 days	Day 1	Perform every 168 days x1		Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Physical exam will be performed at screening/baseline, at each post-treatment follow-up visit and at EOT (24 months). Physical exam will include vital sign (blood pressure, oral or temporal temperature, pulse, and respiratory rate) and weight measurements
			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	RBANS Cognitive Test
			Imaging
  	MRI BRAIN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Brain MRI without and with contrast, which includes high-resolution pre- and postcontrast 3D T1 BRAVO/MPRAGE, T1 subtraction map, and T2 CUBE/SPACE will be performed at baseline, one month after HS-GKRS, every six months thereafter and at EOT.
			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	SignateraTM Blood Collection (ctDNA Measurement) 

Blood collection for ctDNA measurement (SignateraTM ) will be performed at baseline, after HS-GKRS and before the start of systemic therapy, at one month after the start of therapy and every six months  thereafter. Blood sample collection will be in 4 Streck tubes (equivalent to 40mL of blood or 20mL plasma). Plasma and buffy coat will be separated within 2 hours of collection. After processing, samples will be stored at -80oC for ctDNA analysis in Dr. Jenny Chang's laboratory.
			Labs
☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	CBC with platelet count and differential WBC count will be performed at screening, baseline, at post-treatment follow-up visits and when clinically indicated. 
		☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Clinical chemistry panel (glucose, albumin, sodium, potassium, carbon dioxide, calcium, chloride, BUN, creatinine, total protein, total bilirubin, ALP, ALT, and AST) and evaluation of magnesium, uric acid, and LDH will be performed at screening, baseline, at post-treatment follow-up visits and when clinically indicated
		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Clinical chemistry panel (glucose, albumin, sodium, potassium, carbon dioxide, calcium, chloride, BUN, creatinine, total protein, total bilirubin, ALP, ALT, and AST) and evaluation of magnesium, uric acid, and LDH will be performed at screening, baseline, at each study visit and when clinically indicated. 
		☑	URIC ACID LEVEL	Interval: --	Occurrences: --	Comments:	Clinical chemistry panel (glucose, albumin, sodium, potassium, carbon dioxide, calcium, chloride, BUN, creatinine, total protein, total bilirubin, ALP, ALT, and AST) and evaluation of magnesium, uric acid, and LDH will be performed at screening, baseline, at each study visit and when clinically indicated. 
		☑	LDH	Interval: --	Occurrences: --	Comments:	Clinical chemistry panel (glucose, albumin, sodium, potassium, carbon dioxide, calcium, chloride, BUN, creatinine, total protein, total bilirubin, ALP, ALT, and AST) and evaluation of magnesium, uric acid, and LDH will be performed at screening, baseline, at each study visit and when clinically indicated. 
			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Prior /concomitant Medications 

All concomitant medications will be recorded on the CRF including all prescription, over the counter, and IV medications and fluids. All concomitant medications received within 28 days before the start of trial treatment and 30 days after the last dose of trial treatment should be recorded.
			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	AEs and SAEs will be captured from the time of HS-GKRS up to the end of the safety follow-up period.
					
M12D1	Repeat 1 time	Cycle length: 168 days	Day 1	Perform every 168 days x1		Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Physical exam will be performed at screening/baseline, at each post-treatment follow-up visit and at EOT (24 months). Physical exam will include vital sign (blood pressure, oral or temporal temperature, pulse, and respiratory rate) and weight measurements
			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	RBANS Cognitive Test
			Imaging
  	MRI BRAIN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Brain MRI without and with contrast, which includes high-resolution pre- and postcontrast 3D T1 BRAVO/MPRAGE, T1 subtraction map, and T2 CUBE/SPACE will be performed at baseline, one month after HS-GKRS, every six months thereafter and at EOT.
			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	SignateraTM Blood Collection (ctDNA Measurement) 

Blood collection for ctDNA measurement (SignateraTM ) will be performed at baseline, after HS-GKRS and before the start of systemic therapy, at one month after the start of therapy and every six months  thereafter. Blood sample collection will be in 4 Streck tubes (equivalent to 40mL of blood or 20mL plasma). Plasma and buffy coat will be separated within 2 hours of collection. After processing, samples will be stored at -80oC for ctDNA analysis in Dr. Jenny Chang's laboratory.
			Labs
☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	CBC with platelet count and differential WBC count will be performed at screening, baseline, at post-treatment follow-up visits and when clinically indicated. 
		☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Clinical chemistry panel (glucose, albumin, sodium, potassium, carbon dioxide, calcium, chloride, BUN, creatinine, total protein, total bilirubin, ALP, ALT, and AST) and evaluation of magnesium, uric acid, and LDH will be performed at screening, baseline, at post-treatment follow-up visits and when clinically indicated
		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Clinical chemistry panel (glucose, albumin, sodium, potassium, carbon dioxide, calcium, chloride, BUN, creatinine, total protein, total bilirubin, ALP, ALT, and AST) and evaluation of magnesium, uric acid, and LDH will be performed at screening, baseline, at each study visit and when clinically indicated. 
		☑	URIC ACID LEVEL	Interval: --	Occurrences: --	Comments:	Clinical chemistry panel (glucose, albumin, sodium, potassium, carbon dioxide, calcium, chloride, BUN, creatinine, total protein, total bilirubin, ALP, ALT, and AST) and evaluation of magnesium, uric acid, and LDH will be performed at screening, baseline, at each study visit and when clinically indicated. 
		☑	LDH	Interval: --	Occurrences: --	Comments:	Clinical chemistry panel (glucose, albumin, sodium, potassium, carbon dioxide, calcium, chloride, BUN, creatinine, total protein, total bilirubin, ALP, ALT, and AST) and evaluation of magnesium, uric acid, and LDH will be performed at screening, baseline, at each study visit and when clinically indicated. 
			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Prior /concomitant Medications 

All concomitant medications will be recorded on the CRF including all prescription, over the counter, and IV medications and fluids. All concomitant medications received within 28 days before the start of trial treatment and 30 days after the last dose of trial treatment should be recorded.
			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	AEs and SAEs will be captured from the time of HS-GKRS up to the end of the safety follow-up period.
					
M18D1	Repeat 1 time	Cycle length: 168 days	Day 1	Perform every 168 days x1		Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Physical exam will be performed at screening/baseline, at each post-treatment follow-up visit and at EOT (24 months). Physical exam will include vital sign (blood pressure, oral or temporal temperature, pulse, and respiratory rate) and weight measurements
			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	RBANS Cognitive Test
			Imaging
  	MRI BRAIN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Brain MRI without and with contrast, which includes high-resolution pre- and postcontrast 3D T1 BRAVO/MPRAGE, T1 subtraction map, and T2 CUBE/SPACE will be performed at baseline, one month after HS-GKRS, every six months thereafter and at EOT.
			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	SignateraTM Blood Collection (ctDNA Measurement) 

Blood collection for ctDNA measurement (SignateraTM ) will be performed at baseline, after HS-GKRS and before the start of systemic therapy, at one month after the start of therapy and every six months  thereafter. Blood sample collection will be in 4 Streck tubes (equivalent to 40mL of blood or 20mL plasma). Plasma and buffy coat will be separated within 2 hours of collection. After processing, samples will be stored at -80oC for ctDNA analysis in Dr. Jenny Chang's laboratory.
			Labs
☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	CBC with platelet count and differential WBC count will be performed at screening, baseline, at post-treatment follow-up visits and when clinically indicated. 
		☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Clinical chemistry panel (glucose, albumin, sodium, potassium, carbon dioxide, calcium, chloride, BUN, creatinine, total protein, total bilirubin, ALP, ALT, and AST) and evaluation of magnesium, uric acid, and LDH will be performed at screening, baseline, at post-treatment follow-up visits and when clinically indicated
		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Clinical chemistry panel (glucose, albumin, sodium, potassium, carbon dioxide, calcium, chloride, BUN, creatinine, total protein, total bilirubin, ALP, ALT, and AST) and evaluation of magnesium, uric acid, and LDH will be performed at screening, baseline, at each study visit and when clinically indicated. 
		☑	URIC ACID LEVEL	Interval: --	Occurrences: --	Comments:	Clinical chemistry panel (glucose, albumin, sodium, potassium, carbon dioxide, calcium, chloride, BUN, creatinine, total protein, total bilirubin, ALP, ALT, and AST) and evaluation of magnesium, uric acid, and LDH will be performed at screening, baseline, at each study visit and when clinically indicated. 
		☑	LDH	Interval: --	Occurrences: --	Comments:	Clinical chemistry panel (glucose, albumin, sodium, potassium, carbon dioxide, calcium, chloride, BUN, creatinine, total protein, total bilirubin, ALP, ALT, and AST) and evaluation of magnesium, uric acid, and LDH will be performed at screening, baseline, at each study visit and when clinically indicated. 
			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Prior /concomitant Medications 

All concomitant medications will be recorded on the CRF including all prescription, over the counter, and IV medications and fluids. All concomitant medications received within 28 days before the start of trial treatment and 30 days after the last dose of trial treatment should be recorded.
			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	AEs and SAEs will be captured from the time of HS-GKRS up to the end of the safety follow-up period.
					
M24D1	Repeat 1 time	Cycle length: 168 days	Day 1	Perform every 168 days x1		Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Physical exam will be performed at screening/baseline, at each post-treatment follow-up visit and at EOT (24 months). Physical exam will include vital sign (blood pressure, oral or temporal temperature, pulse, and respiratory rate) and weight measurements
			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	RBANS Cognitive Test
			Imaging
  	MRI BRAIN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Brain MRI without and with contrast, which includes high-resolution pre- and postcontrast 3D T1 BRAVO/MPRAGE, T1 subtraction map, and T2 CUBE/SPACE will be performed at baseline, one month after HS-GKRS, every six months thereafter and at EOT.
			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	SignateraTM Blood Collection (ctDNA Measurement) 

Blood collection for ctDNA measurement (SignateraTM ) will be performed at baseline, after HS-GKRS and before the start of systemic therapy, at one month after the start of therapy and every six months  thereafter. Blood sample collection will be in 4 Streck tubes (equivalent to 40mL of blood or 20mL plasma). Plasma and buffy coat will be separated within 2 hours of collection. After processing, samples will be stored at -80oC for ctDNA analysis in Dr. Jenny Chang's laboratory.
			Labs
☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	CBC with platelet count and differential WBC count will be performed at screening, baseline, at post-treatment follow-up visits and when clinically indicated. 
		☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Clinical chemistry panel (glucose, albumin, sodium, potassium, carbon dioxide, calcium, chloride, BUN, creatinine, total protein, total bilirubin, ALP, ALT, and AST) and evaluation of magnesium, uric acid, and LDH will be performed at screening, baseline, at post-treatment follow-up visits and when clinically indicated
		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Clinical chemistry panel (glucose, albumin, sodium, potassium, carbon dioxide, calcium, chloride, BUN, creatinine, total protein, total bilirubin, ALP, ALT, and AST) and evaluation of magnesium, uric acid, and LDH will be performed at screening, baseline, at each study visit and when clinically indicated. 
		☑	URIC ACID LEVEL	Interval: --	Occurrences: --	Comments:	Clinical chemistry panel (glucose, albumin, sodium, potassium, carbon dioxide, calcium, chloride, BUN, creatinine, total protein, total bilirubin, ALP, ALT, and AST) and evaluation of magnesium, uric acid, and LDH will be performed at screening, baseline, at each study visit and when clinically indicated. 
		☑	LDH	Interval: --	Occurrences: --	Comments:	Clinical chemistry panel (glucose, albumin, sodium, potassium, carbon dioxide, calcium, chloride, BUN, creatinine, total protein, total bilirubin, ALP, ALT, and AST) and evaluation of magnesium, uric acid, and LDH will be performed at screening, baseline, at each study visit and when clinically indicated. 
			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Prior /concomitant Medications 

All concomitant medications will be recorded on the CRF including all prescription, over the counter, and IV medications and fluids. All concomitant medications received within 28 days before the start of trial treatment and 30 days after the last dose of trial treatment should be recorded.
			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	AEs and SAEs will be captured from the time of HS-GKRS up to the end of the safety follow-up period.
					
EOT	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 168 days x1		Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Physical exam will be performed at screening/baseline, at each post-treatment follow-up visit and at EOT (24 months). Physical exam will include vital sign (blood pressure, oral or temporal temperature, pulse, and respiratory rate) and weight measurements
			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	RBANS Cognitive Test
			Imaging
  	MRI BRAIN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Brain MRI without and with contrast, which includes high-resolution pre- and postcontrast 3D T1 BRAVO/MPRAGE, T1 subtraction map, and T2 CUBE/SPACE will be performed at baseline, one month after HS-GKRS, every six months thereafter and at EOT.
			Labs
☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	CBC with platelet count and differential WBC count will be performed at screening, baseline, at post-treatment follow-up visits and when clinically indicated. 
		☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Clinical chemistry panel (glucose, albumin, sodium, potassium, carbon dioxide, calcium, chloride, BUN, creatinine, total protein, total bilirubin, ALP, ALT, and AST) and evaluation of magnesium, uric acid, and LDH will be performed at screening, baseline, at post-treatment follow-up visits and when clinically indicated
		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Clinical chemistry panel (glucose, albumin, sodium, potassium, carbon dioxide, calcium, chloride, BUN, creatinine, total protein, total bilirubin, ALP, ALT, and AST) and evaluation of magnesium, uric acid, and LDH will be performed at screening, baseline, at each study visit and when clinically indicated. 
		☑	URIC ACID LEVEL	Interval: --	Occurrences: --	Comments:	Clinical chemistry panel (glucose, albumin, sodium, potassium, carbon dioxide, calcium, chloride, BUN, creatinine, total protein, total bilirubin, ALP, ALT, and AST) and evaluation of magnesium, uric acid, and LDH will be performed at screening, baseline, at each study visit and when clinically indicated. 
		☑	LDH	Interval: --	Occurrences: --	Comments:	Clinical chemistry panel (glucose, albumin, sodium, potassium, carbon dioxide, calcium, chloride, BUN, creatinine, total protein, total bilirubin, ALP, ALT, and AST) and evaluation of magnesium, uric acid, and LDH will be performed at screening, baseline, at each study visit and when clinically indicated. 
			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Prior /concomitant Medications 

All concomitant medications will be recorded on the CRF including all prescription, over the counter, and IV medications and fluids. All concomitant medications received within 28 days before the start of trial treatment and 30 days after the last dose of trial treatment should be recorded.
			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	AEs and SAEs will be captured from the time of HS-GKRS up to the end of the safety follow-up period.
					
Safety FUP	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 168 days x1		Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Prior /concomitant Medications 

All concomitant medications will be recorded on the CRF including all prescription, over the counter, and IV medications and fluids. All concomitant medications received within 28 days before the start of trial treatment and 30 days after the last dose of trial treatment should be recorded.
			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	AEs and SAEs will be captured from the time of HS-GKRS up to the end of the safety follow-up period.