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Guidelines

EANO/EURACAN

2019: Franceschi et al. EANO–EURACAN clinical practice guideline for diagnosis, treatment, and follow-up of post-pubertal and adult patients with medulloblastoma

Upfront Therapy Older Children

COG ACNS0331 Standard Dose CSRT with Reduced Volume Boost to Tumor Bed

Ages 3+
All patients must begin therapy within 31 days of surgery.

Protocol

Study	Dates of enrollment	Evidence	Comparator	Comparative Efficacy
Michalski et al. 2021 (COG ACNS0331)	2004-04-30 to 2014-01-06	Phase 3 (E-de-esc)	COG ACNS0331 Protocol for Standard Dose CSRT with Standard Volume Boost	Non-inferior EFS (primary endpoint) EFS60: 82.5% vs 80.5% (HR 0.97, 94% CI 1.32)

Note: this protocol is given in two parts, induction (chemoradiation) followed by maintenance. The induction portion lasts 6 weeks, followed by 4 weeks of rest (weeks 7-10), followed by the maintenance portion which lasts for 58 weeks, consisting of alternating A cycles and B cycles (AAB-AAB-AAB). The non-inferiority comparison was one-sided, with the upper bound reported here.

Radiotherapy, induction portion

Craniospinal External beam radiotherapy 23.4 Gy in 13 daily fractions
Tumor Bed Boost External beam radiotherapy 30.6 Gy in 17 daily fractions

Chemotherapy, induction portion

Vincristine (Oncovin) 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute or IV infusion (per institution) once per day on days 8, 15, 22, 29, 36, 43 (Once a week starting one week after CSRT begins)
- Round vincristine down to the nearest 0.1 mg

6-week course, followed by 4-weeks rest, followed by:

Chemotherapy, maintenance part A (Cycles 1, 2, 4, 5, 7, 8)(6 weeks=1 cycle)

Cisplatin (Platinol) 75 mg/m² IV once on day 1
Lomustine (CCNU) 75 mg/m² PO once on day 1 on an empty stomach (at least 2 hours after food) preferably at bedtime (reduce N/V)
- - Pediatric Lomustine Dosing Chart
  - Give Lomustine (CCNU) with at least 8 oz of fluids for children > 3 years old and at least 4 oz of fluids for children < 3 years of age
Vincristine (Oncovin) 1.5 mg/m² (maximum dose of 2 mg) IV once per day on days 1, 8, 15
- - Dose rounded down to the nearest 0.1 mg
  - Can be given IV push over 1-minute or by infusion via minibag as per institution policy

Chemotherapy, maintenance part B (Cycles 3, 6, 9)(4 weeks=1 cycle)

Cyclophosphamide (Cytoxan) 1000 mg/m² IV over 60 minutes once per day on days 1 & 2
Vincristine (Oncovin) 1.5 mg/m² (maximum dose of 2 mg) IV once per day on days 1, 8
- - Dose rounded down to the nearest 0.1 mg
  - Can be given IV push over 1-minute or by infusion via minibag as per institution policy

Supportive therapy, maintenance part B (Cycles 3, 6, 9)(4 weeks=1 cycle)

Mesna (Mesnex) 360 mg/m² IV over 15 to 30 minutes once per day on days 1 & 2
- - Dose is given at least 15 minutes prior to or at the same time as Cyclophosphamide (Cytoxan) and repeated at 4 and 8 hours post Cyclophosphamide (Cytoxan)
  - Can be given via continuous infusion starting 15 to 30 minutes before or at the same time as Cyclophosphamide (Cytoxan) and finished no sooner than 8 hours after the end of the Cyclophosphamide (Cytoxan) infusion

Maintenance is 9 cycles; this is given in an AAB-AAB-AAB sequence, where cycle A is 42 days/6 weeks and cycle B is 28 days/4 weeks

References

COG ACNS0331: Michalski JM, Janss AJ, Vezina LG, Smith KS, Billups CA, Burger PC, Embry LM, Cullen PL, Hardy KK, Pomeroy SL, Bass JK, Perkins SM, Merchant TE, Colte PD, Fitzgerald TJ, Booth TN, Cherlow JM, Muraszko KM, Hadley J, Kumar R, Han Y, Tarbell NJ, Fouladi M, Pollack IF, Packer RJ, Li Y, Gajjar A, Northcott PA. Children's Oncology Group Phase III Trial of Reduced-Dose and Reduced-Volume Radiotherapy With Chemotherapy for Newly Diagnosed Average-Risk Medulloblastoma. J Clin Oncol. 2021 Aug 20;39(24):2685-2697. Epub 2021 Jun 10. link to original article link to PMC article PubMed NCT00085735

COG ACNS0331 Standard Dose CSRT with Standard Volume Boost

Ages 3+
All patients must begin therapy within 31 days of surgery.

Protocol

Study	Dates of enrollment	Evidence	Comparator	Comparative Efficacy
Michalski et al. 2021 (COG ACNS0331)	2004-04-30 to 2014-01-06	Phase 3 (C)	COG ACNS0331 Protocol for Standard Dose CSRT with Reduced Volume Boost to Tumor Bed	Non-inferior EFS

Radiotherapy, induction portion

Craniospinal External beam radiotherapy 23.4 Gy in 13 daily fractions
Posterior Fossa Boost External beam radiotherapy 30.6 Gy in 17 daily fractions

Chemotherapy, induction portion

Vincristine (Oncovin) 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute or IV infusion (per institution) once per day on days 8, 15, 22, 29, 36, 43 (Once a week starting one week after CSRT begins)
- Round vincristine down to the nearest 0.1 mg

chemoradiation is a 6-week course, followed by 4-weeks rest, followed by:

Chemotherapy, maintenance part A (Cycles 1, 2, 4, 5, 7, 8)(6 weeks=1 cycle)

Cisplatin (Platinol) 75 mg/m² IV once on day 1
Lomustine (CCNU) 75 mg/m² PO once on day 1 on an empty stomach (at least 2 hours after food) preferably at bedtime (reduce N/V)
- Pediatric Lomustine Dosing Chart
- Give Lomustine (CCNU) with at least 8 oz of fluids for children > 3 years old and at least 4 oz of fluids for children < 3 years of age
Vincristine (Oncovin) 1.5 mg/m² (maximum dose of 2 mg) IV once per day on days 1, 8, 15
- Dose rounded down to the nearest 0.1 mg
- Can be given IV push over 1-minute or by infusion via minibag as per institution policy

Chemotherapy, maintenance part B (Cycles 3, 6, 9)(4 weeks=1cycle)

Cyclophosphamide (Cytoxan) 1000 mg/m² IV over 60 minutes once per day on days 1 & 2
Vincristine (Oncovin) 1.5 mg/m² (maximum dose of 2 mg) IV once per day on days 1, 8
- Dose rounded down to the nearest 0.1 mg
- Can be given IV push over 1-minute or by infusion via minibag as per institution policy

Supportive therapy, maintenance part B (Cycles 3, 6, 9)(4 weeks=1 cycle)

Mesna (Mesnex) 360 mg/m² IV over 15 to 30 minutes once per day on days 1 & 2
- Dose given at least 15 minutes prior to or at the same time as Cyclophosphamide (Cytoxan) and repeated at 4 and 8 hours post Cyclophosphamide (Cytoxan)
- Can be given via continuous infusion starting 15 to 30 minutes before or at the same time as Cyclophosphamide (Cytoxan) and finished no sooner than 8 hours after the end of the Cyclophosphamide (Cytoxan) infusion

Maintenance is 9 cycles; this is given in an AAB-AAB-AAB sequence, where cycle A is 42 days/6 weeks and cycle B is 28 days/4 weeks

References

COG ACNS0331: Michalski JM, Janss AJ, Vezina LG, Smith KS, Billups CA, Burger PC, Embry LM, Cullen PL, Hardy KK, Pomeroy SL, Bass JK, Perkins SM, Merchant TE, Colte PD, Fitzgerald TJ, Booth TN, Cherlow JM, Muraszko KM, Hadley J, Kumar R, Han Y, Tarbell NJ, Fouladi M, Pollack IF, Packer RJ, Li Y, Gajjar A, Northcott PA. Children's Oncology Group Phase III Trial of Reduced-Dose and Reduced-Volume Radiotherapy With Chemotherapy for Newly Diagnosed Average-Risk Medulloblastoma. J Clin Oncol. 2021 Aug 20;39(24):2685-2697. Epub 2021 Jun 10. link to original article link to PMC article PubMed NCT00085735

COG ACNS0332 Protocol A

Protocol

Study	Dates of enrollment	Evidence	Comparator	Comparative Efficacy
Leary et al. 2021 (COG ACNS0332)	2007-03 to 2018-09	Phase 3 (C)	COG ACNS0332 Protocol B (with carboplatin)	Did not meet primary endpoint of EFS

Radiotherapy, induction

Craniospinal External beam radiotherapy 36 Gy in 20 daily fractions (Monday - Friday)
Posterior Fossa Boost External beam radiotherapy 19.8 Gy in 11 daily fractions (Cumulative dose of 55.8 Gy)

For additional boost details, such as technique and location, please see the full protocol as this depends on the site of metastases and disease stage

Chemotherapy, induction

Vincristine (Oncovin) 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute or IV infusion (per institution) once per day on days 1, 8, 15, 22, 29, 36 (Once a week starting within one week of the start of CSRT)
- Round vincristine down to the nearest 0.1 mg

6-week course, followed by:

Chemotherapy, maintenance

Cisplatin (Platinol) 75 mg/m² IV over 60 minutes once on day 1
Vincristine (Oncovin) 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute or IV infusion (per institution) once per day on days 1, 8
- Round vincristine down to the nearest 0.1 mg
Cyclophosphamide (Cytoxan) 1000 mg/m² IV over 60 minutes once per day on days 2 & 3, given at least 24 hours after cisplatin on day 2

28-day cycle for 6 cycles; begin each cycle on day 29 and when ANC ≥ 750/μL, platelets ≥ 75,000/μL, and the patient has been off of myeloid growth factor for at least 24 hours

References

COG ACNS0332: Leary SES, Packer RJ, Li Y, Billups CA, Smith KS, Jaju A, Heier L, Burger P, Walsh K, Han Y, Embry L, Hadley J, Kumar R, Michalski J, Hwang E, Gajjar A, Pollack IF, Fouladi M, Northcott PA, Olson JM. Efficacy of Carboplatin and Isotretinoin in Children With High-risk Medulloblastoma: A Randomized Clinical Trial From the Children's Oncology Group. JAMA Oncol. 2021 Sep 1;7(9):1313-1321. link to original article link to PMC article PubMed NCT00392327

COG ACNS0332 Protocol B

Protocol

Study	Dates of enrollment	Evidence	Comparator	Comparative Efficacy
Leary et al. 2021 (COG ACNS0332)	2007-03 to 2018-09	Phase 3 (E-esc)	COG ACNS0332 Protocol A (no carboplatin)	Did not meet primary endpoint of EFS

Radiotherapy, induction

Craniospinal External beam radiotherapy 36 Gy in 20 daily fractions (Monday - Friday)
Posterior Fossa Boost External beam radiotherapy 19.8 Gy in 11 daily fractions (Cumulative dose of 55.8 Gy)

For additional boost details, such as technique and location, please see the full protocol as this depends on the site of metastases and disease stage

Chemotherapy, induction

Vincristine (Oncovin) 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute or IV infusion (per institution) once per day on days 1, 8, 15, 22, 29, 36 (Once a week starting within one week of the start of CSRT)
- Round vincristine down to the nearest 0.1 mg
- Administer prior to Carboplatin
Carboplatin (Paraplatin) 35 mg/m² IV over 15 minutes once per day, given 1 to 4 hours prior to radiation therapy (Total of 30 doses)
- First dose administered on the first day of radiation therapy
- Should be HELD if radiation treatment is not given
- Since there are 31 fractions of radiation, No carboplatin should be given prior to the final radiation fraction

6-week course, followed by:

Chemotherapy, maintenance

Cisplatin (Platinol) 75 mg/m² IV over 60 minutes once on day 1
Vincristine (Oncovin) 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute or IV infusion (per institution) once per day on days 1 & 8
- Round vincristine down to the nearest 0.1 mg
Cyclophosphamide (Cytoxan) 1000 mg/m² IV over 60 minutes once per day on days 2 & 3, given at least 24 hours after cisplatin on day 2

28-day cycle for 6 cycles; begin each cycle on day 29 and when ANC ≥ 750/μL, platelets ≥ 75,000/μL, and the patient has been off of myeloid growth factor for at least 24 hours

References

COG ACNS0332: Leary SES, Packer RJ, Li Y, Billups CA, Smith KS, Jaju A, Heier L, Burger P, Walsh K, Han Y, Embry L, Hadley J, Kumar R, Michalski J, Hwang E, Gajjar A, Pollack IF, Fouladi M, Northcott PA, Olson JM. Efficacy of Carboplatin and Isotretinoin in Children With High-risk Medulloblastoma: A Randomized Clinical Trial From the Children's Oncology Group. JAMA Oncol. 2021 Sep 1;7(9):1313-1321. link to original article link to PMC article PubMed NCT00392327

Upfront Therapy, Younger Children

COG ACNS0334 Protocol A

Induction, 21-day Cycle for 3 cycles

Study	Dates of enrollment	Evidence	Comparator	Comparative Efficacy
Awaiting publication (COG ACNS0334)	2007-NR	Phase 3 (C)	COG ACNS0334 Protocol B (HD-MTX)	TBD

Chemotherapy

Vincristine (Oncovin) 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute or IV infusion (per institution) once per day on days 1, 8, 15
Etoposide (Vepesid) 2.5 mg/kg (maximum concentration of Etoposide (Vepesid) is 0.4 mg/ml) IV over 60 minutes once per day on days 1, 2, 3
- Begin Etoposide (Vepesid) infusion 1 hour before the Cyclophosphamide (Cytoxan) or Cisplatin (Platinol) infusions
Cyclophosphamide (Cytoxan) 60 mg/kg IV over 60 minutes once per day on days 1 & 2, given with hyperhydration and mesna
- Must reduce urine specific gravity to ≤ 1.010 prior to administration and maintain urine output at greater than 3 mL/kg/hour
Cisplatin (Platinol) 3.5 mg/kg IV over 6 hours once on day 3
- Cisplatin (Platinol) doses may require the use of mannitol to augment hydration and diuresis
- Must reduce urine specific gravity to ≤1.010 prior to starting of [[Cisplatin (Platinol)]

Supportive therapy,

Mesna (Mesnex) 12 mg/kg IV five times per day on days 1 & 2
- Dose 1: Initial bolus dose of may be administered before or at the same time as the Cyclophosphamide (Cytoxan)
- Dose 2: A 3-hour infusion immediately following the Cyclophosphamide (Cytoxan) infusion (Hours 2 - 5)
- Doses 3 to 5: 3 subsequent bolus doses are given at hours 6, 9, 12, or by institutional protocol
- Mesna (Mesnex) may also be given as a 24-hour continuous infusion starting 30 minutes before cyclophosphamide and finishing no sooner than 12 hours after the end of the cyclophosphamide infusion, or by institutional protocol
Filgrastim (Neupogen) 5 mcg/kg SC or IV (per institutional policy) once per day, starting 24-36 hours after Cisplatin infusion and continue until ANC > 1000/μL then increase to 10 mcg/kg and plan for harvest 2 days later. If PBSC harvest after the first cycle is insufficient, then harvests may occur after the second (and third if required) cycle. If PBSC harvest is not planned, continue until ANC > 2000/μL.

21-day cycle for 3 cycles

Consolidation, 28-day cycle for 3 cycles

Study	Dates of enrollment	Evidence	Comparator	Comparative Efficacy
Awaiting publication (COG ACNS0334)	2007-NR	Phase 3 (C)	COG ACNS0334 Protocol B (HD-MTX)	TBD

Chemotherapy, Autologous Transplant

Carboplatin (Paraplatin) 17 mg/kg IV over 2 hours once per day on days 1 & 2
- If corrected GFR is < 100 ml/min/1.73m², the Carboplatin (Paraplatin) dose should be calculated using the modified Calvert formula
Thiotepa (Thioplex) 10 mg/kg IV over 2 hours once per day on days 1 & 2, given immediately following Carboplatin (Paraplatin) administration
- Skincare, frequent bathing, and linen changes during Thiotepa (Thioplex) administration are important and required to avoid chemical skin burns
PBSC on day 4

Supportive therapy, Autologous Transplant

Filgrastim (Neupogen) 5 mcg/kg SC or IV (per institutional policy) once per day, starting on day 5 (24 hours after infusion of PBSC) and continue until ANC > 2000/μL
- If Filgrastim (Neupogen) is given IV, it should be administered by IV bolus over 15 to 30 minutes or by continuous infusion

28-day cycle for 3 cycles

References

COG ACNS0334: NCT00336024

COG ACNS0334 Protocol B

Induction

Study	Dates of enrollment	Evidence	Comparator	Comparative Efficacy
Awaiting publication (COG ACNS0334)	2007-NR	Phase 3 (E-esc)	COG ACNS0334 Protocol A (no HD-MTX)	TBD

Chemotherapy, induction

3 cycles

Vincristine (Oncovin) 0.05 mg/kg (maximum single dose of 2 mg) IV push over 1 minute or IV infusion (per institution) once per day on days 1, 8, 15
High Dose Methotrexate (MTX) 400 mg/kg (20 gram maximum) IV over 4 hours once on day 1
Etoposide (Vepesid) 2.5 mg/kg (maximum concentration of Etoposide (Vepesid) is 0.4 mg/ml) IV over 60 minutes once per day on days A, B, C
- Day A of chemotherapy begins when the serum Methotrexate (MTX) level is less than 0.1 micromolar
- Begin Etoposide (Vepesid) infusion 1 hour before the Cyclophosphamide or CIS platin infusions
Cyclophosphamide (Cytoxan) 60 mg/kg IV over 60 minutes once per day on days A & B
- Day A of chemotherapy begins when the serum Methotrexate (MTX) level is less than 0.1 micromolar
- Must reduce urine specific gravity to ≤ 1.010 prior to administration and maintain urine output at greater than 3 mL/kg/hour
Cisplatin (Platinol) 3.5 mg/kg IV over 6 hours once on day C
- Day A of chemotherapy begins when the serum Methotrexate (MTX) level is less than 0.1 micromolar
- Cisplatin (Platinol) doses may require use of mannitol to augment hydration and diuresis
- Must reduce urine specific gravity to ≤ 1.010 prior to administration and maintain urine output at greater than 3 mL/kg/hour

Supportive therapy, induction

Folinic acid (Leucovorin) 10 mg/m² PO or IV every 6 hours until serum Methotrexate (MTX) levels are less than 0.1 micromolar
- Folinic acid (Leucovorin) must be started 24 hours from the beginning of the Methotrexate (MTX) infusion
Mesna (Mesnex) 12 mg/kg IV five times per day on days A & B
- Dose 1: Initial bolus dose of Mesna (Mesnex) may be administered before or at the same time as the Cyclophosphamide (Cytoxan)
- Dose 2: A 3 hour infusion of Mesna (Mesnex) immediately following the Cyclophosphamide (Cytoxan) infusion
- Dose 3 to 5: 3 subsequent Mesna (Mesnex) bolus doses given at hours 6, 9, 12 or by institutional protocol
- Mesna (Mesnex) 60 mg/kg/day may also be given as a 24 hour continuous infusion by institutional protocol
- Day A of chemotherapy begins when the serum Methotrexate (MTX) level is less than 0.1 micromolar
Filgrastim (Neupogen) 5 mcg/kg SubQ or IV (per institutional policy) once per day starting on day D (24-36 hours after Cisplatin infusion) and continue until ANC > 1000/μL then increase to 10 mcg/kg and plan for harvest 2 days later. If PBSC harvest after the first cycle is insufficient, then harvests may occur after the second (and third if required) cycle. If PBSC harvest is not planned, continue until ANC > 2000/μL.

21-day course, followed by:

Consolidation

Study	Dates of enrollment	Evidence	Comparator	Comparative Efficacy
Awaiting publication (COG ACNS0334)	2007-NR	Phase 3 (E-esc)	COG ACNS0334 Protocol A (no HD-MTX)	TBD

Chemotherapy, Autologous Transplan

3 cycles

Carboplatin (Paraplatin) 17 mg/kg IV over 2 hours given once per day on days 1 & 2
- If corrected GFR is < 100 ml/min/1.73m², the Carboplatin (Paraplatin) dose should be calculated using the modified Calvert formula
Thiotepa (Thioplex) 10 mg/kg IV over 2 hours once per day on days 1 & 2 immediately following Carboplatin (Paraplatin) administration
- Skincare, frequent bathing, and linen changes during Thiotepa (Thioplex) administration are important and required to avoid chemical skin burns
PBSC on day 4

Supportive therapy, Autologous Transplant

Filgrastim (Neupogen) 5 mcg/kg SubQ or IV (per institutional policy) once per day starting on day 5 (24 hours after infusion of PBSC) and continue until ANC > 2000/μL
- If Filgrastim (Neupogen) is given IV, it should be administered by IV bolus over 15 to 30 minutes or by continuous infusion

28-day cycle

References

COG ACNS0334: NCT00336024

Head Start III Protocol D2

Protocol

Study	Dates of enrollment	Evidence
Dhall et al. 2020 (Head Start III)	2003-05 to 2009-12	Non-randomized

Chemotherapy, induction cycles 1 & 3

Cisplatin (Platinol) 3.5 mg/kg IV once on day 1
Vincristine (Oncovin) 0.05 mg/kg (maximum dose of 2 mg) IV once per day on days 1, 8, 15
Cyclophosphamide (Cytoxan) 55 mg/kg IV once per day on days 2 & 3
Etoposide (Vepesid) 4 mg/kg IV once per day on days 2 & 3
High Dose Methotrexate (MTX) 270 mg/kg IV over 4 hours once on day 3

Supportive therapy, induction cycles 1 & 3

Folinic acid (Leucovorin) 10 mg/m² PO or IV every 6 hours until serum Methotrexate (MTX) levels are less than 0.1 micromolar
- Folinic acid (Leucovorin) must be started 24 hours from the beginning of the Methotrexate (MTX) infusion

15-day cycle

Chemotherapy, induction cycles 2 & 4

Vincristine (Oncovin) 0.05 mg/kg (maximum dose of 2 mg) IV once per day on days 1, 8, 15
Cyclophosphamide (Cytoxan) 55 mg/kg IV once per day on days 2 & 3
Etoposide (Vepesid) 1.65 mg/kg PO once per day on days 1 to 10
Temozolomide (Temodar) 6.5 mg/kg PO once per day on days 1 to 5

15-day cycles

Chemotherapy, induction cycle 5

Cisplatin (Platinol) 3.5 mg/kg IV once on day 1
Cyclophosphamide (Cytoxan) 55 mg/kg IV once per day on days 2 & 3
Etoposide (Vepesid) 4 mg/kg IV once per day on days 2 & 3
High Dose Methotrexate (MTX) 270 mg/kg IV over 4 hours once on day 3

Supportive therapy, induction cycle 5

Folinic acid (Leucovorin) 10 mg/m² PO or IV every 6 hours until serum Methotrexate (MTX) levels are less than 0.1 micromolar
- Folinic acid (Leucovorin) must be started 24 hours from the beginning of the Methotrexate (MTX) infusion

15-day course; patients with no evidence of disease (NED) after induction or second look surgery proceed to:

Chemotherapy, myeloablative with autologous stem cell rescue

Carboplatin (Paraplatin) AUC of 7/day once per day on days 1 to 3
Thiotepa (Thioplex) 300 mg/m² IV once per day on days 1 to 3 immediately following Carboplatin (Paraplatin) administration
Etoposide (Vepesid) 250 mg/m² IV once per day on days 1 to 3

3-day course

References

Head Start III: Dhall G, O'Neil SH, Ji L, Haley K, Whitaker AM, Nelson MD, Gilles F, Gardner SL, Allen JC, Cornelius AS, Pradhan K, Garvin JH, Olshefski RS, Hukin J, Comito M, Goldman S, Atlas MP, Walter AW, Sands S, Sposto R, Finlay JL. Excellent outcome of young children with nodular desmoplastic medulloblastoma treated on "Head Start" III: a multi-institutional, prospective clinical trial. Neuro Oncol. 2020 Dec 18;22(12):1862-1872. link to original article link to PMC article PubMed NCT00392327

SJMB-96 Protocol High Risk

Protocol

Study	Dates of enrollment	Evidence
Gajjar et al. 2006 (SJMB-96)	1996-10 to 2003-05	Non-randomized

Chemotherapy

2 cycles

Topotecan (Hycamtin) 5.5 mg/m² IV over 4 hours once per day on days 1 to 5
- Day 1 Topotecan (Hycamtin) plasma concentration will be used to adjust the dose (see full protocol?)

Supportive therapy

Filgrastim (Neupogen) 10 mcg/kg SubQ or IV (per institutional policy) mobilization prior to PBSC harvest
- PBSC harvest after first Topotecan (Hycamtin) course, or second Topotecan (Hycamtin) course if first PBSC is inadequate

14-day Cycle

Radiotherapy

Craniospinal axis External beam radiotherapy by the following staging:
- M₀ - M₁: 36 Gy in 18 daily fractions
- M₂ - M₃: 36 to 39.6 Gy in 18 to 22 daily fractions
  - See protocol for additional details on dose
Posterior fossa External beam radiotherapy 55.8 Gy in 31 daily fractions
- Local boost External beam radiotherapy to 59.4 Gy in 33 daily fractions at investigator's option for residual tumor measuring > 1.5 cm²
6-week rest period following radiotherapy

~ 6 week duration

Chemotherapy, High Dose with PBSC support

4 cycles

Amifostine (Ethyol) 600 mg/m² IV push over 1 minute given 5 minutes prior to Cisplatin (Platinol) infusion and 3 hours into Cisplatin (Platinol) infusion once on day -4
Cisplatin (Platinol) 75 mg/m² IV over 6 hours once on day -4
Vincristine (Oncovin) 1.5 mg/m² (maximum dose of 2 mg) IV push once per day on days -4 & +6
Cyclophosphamide (Cytoxan) 2000 mg/m² IV over 60 minutes once per day on days -3 & -2

Supportive therapy

Mesna (Mesnex) 500 mg/m² IV push 15 minutes prior to Cyclophosphamide (Cytoxan) infusion once per day on days -3 & -2
Mesna (Mesnex) 1500 mg/m² IV continuous infusion on days -3, -2
PBSC Infusion on day 0
Filgrastim (Neupogen) 5 mcg/kg SubQ or IV (per institutional policy) once per day beginning on day 1 (24-36 hours after PBSC reinfusion) and continue for at least 7 days or continue until ANC > 2000/μL for 2 consecutive days.

28-day cycles

References

SJMB-96: Gajjar A, Chintagumpala M, Ashley D, Kellie S, Kun LE, Merchant TE, Woo S, Wheeler G, Ahern V, Krasin MJ, Fouladi M, Broniscer A, Krance R, Hale GA, Stewart CF, Dauser R, Sanford RA, Fuller C, Lau C, Boyett JM, Wallace D, Gilbertson RJ. Risk-adapted craniospinal radiotherapy followed by high-dose chemotherapy and stem-cell rescue in children with newly diagnosed medulloblastoma (St Jude Medulloblastoma-96): long-term results from a prospective, multicentre trial. Lancet Oncol. 2006 Oct;7(10):813-820 link to original article PubMed NCT00003211
1. Toxicity update: Laughton SJ, Merchant TE, Sklar CA, Kun LE, Fouladi M, Broniscer A, Morris EB, Sanders RP, Krasin MJ, Shelso J, Xiong Z, Wallace D, Gajjar A. Endocrine outcomes for children with embryonal brain tumors after risk-adapted craniospinal and conformal primary-site irradiation and high-dose chemotherapy with stem-cell rescue on the SJMB-96 trial. J Clin Oncol. 2008 Mar;26(7):1112-1118 link to original article PubMed

SJMB-96 Protocol Average Risk

Protocol

Study	Dates of enrollment	Evidence
Gajjar et al. 2006 (SJMB-96)	1996-10 to 2003-05	Non-randomized

Growth factor therapy

Filgrastim (Neupogen) 10 mcg/kg SubQ or IV (per institutional policy) mobilization prior to PBSC harvest

Radiotherapy

Craniospinal axis External beam radiotherapy 23.4 Gy in 13 daily fractions
Posterior fossa External beam radiotherapy 55.8 Gy in 31 daily fractions
6 week rest period following radiotherapy

~ 6 week duration

Chemotherapy, High Dose with PBSC support

4 cycles

Amifostine (Ethyol) 600 mg/m² IV push over 1 minute given 5 minutes prior to Cisplatin (Platinol) infusion and 3 hours into Cisplatin (Platinol) infusion once on day -4
Cisplatin (Platinol) 75 mg/m² IV over 6 hours once on day -4
Vincristine (Oncovin) 1.5 mg/m² (maximum dose of 2 mg) IV push once per day on days -4 & +6
Cyclophosphamide (Cytoxan) 2000 mg/m² IV over 60 minutes once per day on days -3 & -2

Supportive medications

Mesna (Mesnex) 500 mg/m² IV push 15 minutes prior to Cyclophosphamide (Cytoxan) infusion once per day on days -3 & -2
Mesna (Mesnex) 1500 mg/m² IV continuous infusion on days -3 & -2
PBSC Infusion on day 0
Filgrastim (Neupogen) 5 mcg/kg SubQ or IV (per institutional policy) once per day beginning on day 1 (24-36 hours after PBSC reinfusion) and continue for at least 7 days or continue until ANC > 2000/μL for 2 consecutive days.

28-day cycles

References

SJMB-96: Gajjar A, Chintagumpala M, Ashley D, Kellie S, Kun LE, Merchant TE, Woo S, Wheeler G, Ahern V, Krasin MJ, Fouladi M, Broniscer A, Krance R, Hale GA, Stewart CF, Dauser R, Sanford RA, Fuller C, Lau C, Boyett JM, Wallace D, Gilbertson RJ. Risk-adapted craniospinal radiotherapy followed by high-dose chemotherapy and stem-cell rescue in children with newly diagnosed medulloblastoma (St Jude Medulloblastoma-96): long-term results from a prospective, multicentre trial. Lancet Oncol. 2006 Oct;7(10):813-820 link to original article PubMed NCT00003211
1. Toxicity update: Laughton SJ, Merchant TE, Sklar CA, Kun LE, Fouladi M, Broniscer A, Morris EB, Sanders RP, Krasin MJ, Shelso J, Xiong Z, Wallace D, Gajjar A. Endocrine outcomes for children with embryonal brain tumors after risk-adapted craniospinal and conformal primary-site irradiation and high-dose chemotherapy with stem-cell rescue on the SJMB-96 trial. J Clin Oncol. 2008 Mar;26(7):1112-1118 link to original article PubMed

@@ Line 41: / Line 41: @@
 ====Chemotherapy, induction portion====
-*[[Vincristine (Oncovin)]] 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute or IV infusion (per institution) once on day 8, 15, 22, 29, 36, 43 (Once a week starting one week after CSRT begins)
+*[[Vincristine (Oncovin)]] 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute or IV infusion (per institution) once per day on days 8, 15, 22, 29, 36, 43 (Once a week starting one week after CSRT begins)
 **Round vincristine '''down''' to the nearest 0.1 mg
-'''chemoradiation is a 6-week course, followed by 4-weeks rest, followed by:'''
+'''6-week course, followed by 4-weeks rest, followed by:'''
 ====Chemotherapy, maintenance part A (Cycles 1, 2, 4, 5, 7, 8)(6 weeks=1 cycle)====
@@ Line 55: / Line 55: @@
 ====Chemotherapy, maintenance part B (Cycles 3, 6, 9)(4 weeks=1 cycle)====
-*[[Cyclophosphamide (Cytoxan)]] 1000 mg/m<sup>2</sup> IV given over 1 hour on Days 1, 2
+*[[Cyclophosphamide (Cytoxan)]] 1000 mg/m<sup>2</sup> IV over 60 minutes once per day on days 1 & 2
 *[[Vincristine (Oncovin)]] 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV once per day on days 1, 8
 ***Dose rounded '''down''' to the nearest 0.1 mg
@@ Line 61: / Line 61: @@
 ====Supportive therapy, maintenance part B (Cycles 3, 6, 9)(4 weeks=1 cycle)====
-*[[Mesna (Mesnex)]] 360 mg/m<sup>2</sup> IV over 15 to 30 minutes on Days 1, 2
+*[[Mesna (Mesnex)]] 360 mg/m<sup>2</sup> IV over 15 to 30 minutes once per day on days 1 & 2
 ***Dose is given at least 15 minutes prior to or at the same time as [[Cyclophosphamide (Cytoxan)]] and repeated at 4 and 8 hours post [[Cyclophosphamide (Cytoxan)]]
 ***Can be given via continuous infusion starting 15 to 30 minutes before or at the same time as [[Cyclophosphamide (Cytoxan)]] and finished no sooner than 8 hours after the end of the [[Cyclophosphamide (Cytoxan)]] infusion
@@ Line 95: / Line 95: @@
 ====Chemotherapy, induction portion====
-*[[Vincristine (Oncovin)]] 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute or IV infusion (per institution) once on day 8, 15, 22, 29, 36, 43 (Once a week starting one week after CSRT begins)
+*[[Vincristine (Oncovin)]] 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute or IV infusion (per institution) once per day on days 8, 15, 22, 29, 36, 43 (Once a week starting one week after CSRT begins)
 **Round vincristine '''down''' to the nearest 0.1 mg
 '''chemoradiation is a 6-week course, followed by 4-weeks rest, followed by:'''
@@ Line 108: / Line 108: @@
 ====Chemotherapy, maintenance part B (Cycles 3, 6, 9)(4 weeks=1cycle)====
-*[[Cyclophosphamide (Cytoxan)]] 1000 mg/m<sup>2</sup> IV given over 1 hour on Days 1, 2
+*[[Cyclophosphamide (Cytoxan)]] 1000 mg/m<sup>2</sup> IV over 60 minutes once per day on days 1 & 2
 *[[Vincristine (Oncovin)]] 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV once per day on days 1, 8
 **Dose rounded '''down''' to the nearest 0.1 mg
@@ Line 114: / Line 114: @@
 ====Supportive therapy, maintenance part B (Cycles 3, 6, 9)(4 weeks=1 cycle)====
-*[[Mesna (Mesnex)]] 360 mg/m<sup>2</sup> IV over 15 to 30 minutes on Days 1, 2
+*[[Mesna (Mesnex)]] 360 mg/m<sup>2</sup> IV over 15 to 30 minutes once per day on days 1 & 2
 **Dose given at least 15 minutes prior to or at the same time as [[Cyclophosphamide (Cytoxan)]] and repeated at 4 and 8 hours post [[Cyclophosphamide (Cytoxan)]]
 **Can be given via continuous infusion starting 15 to 30 minutes before or at the same time as [[Cyclophosphamide (Cytoxan)]] and finished no sooner than 8 hours after the end of the [[Cyclophosphamide (Cytoxan)]] infusion
@@ Line 146: / Line 146: @@
   For additional boost details, such as technique and location, please see the full protocol as this depends on the site of metastases and disease stage
 ====Chemotherapy, induction====
-*[[Vincristine (Oncovin)]] 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute or IV infusion (per institution) once on day 1, 8, 15, 22, 29, 36 (Once a week starting within one week of the start of CSRT)
+*[[Vincristine (Oncovin)]] 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute or IV infusion (per institution) once per day on days 1, 8, 15, 22, 29, 36 (Once a week starting within one week of the start of CSRT)
 **Round vincristine '''down''' to the nearest 0.1 mg
 '''6-week course, followed by:'''
@@ Line 153: / Line 153: @@
 *[[Vincristine (Oncovin)]] 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute or IV infusion (per institution) once per day on days 1, 8
 **Round vincristine '''down''' to the nearest 0.1 mg
-*[[Cyclophosphamide (Cytoxan)]] 1000 mg/m<sup>2</sup> IV over 60 minutes once on days 2, 3, '''given at least 24 hours after cisplatin on day 2'''
+*[[Cyclophosphamide (Cytoxan)]] 1000 mg/m<sup>2</sup> IV over 60 minutes once per day on days 2 & 3, '''given at least 24 hours after cisplatin on day 2'''
-'''28-day cycle for 6 cycles; begin each cycle on Day 29 and when ANC ≥ 750/μL, platelets ≥ 75,000/μL, and the patient has been off of myeloid growth factor for at least 24 hours'''
+'''28-day cycle for 6 cycles; begin each cycle on day 29 and when ANC ≥ 750/μL, platelets ≥ 75,000/μL, and the patient has been off of myeloid growth factor for at least 24 hours'''
 </div></div>
 ===References===
@@ Line 194: / Line 194: @@
 **Round vincristine '''down''' to the nearest 0.1 mg
 *[[Cyclophosphamide (Cytoxan)]] 1000 mg/m<sup>2</sup> IV over 60 minutes once per day on days 2 & 3, '''given at least 24 hours after cisplatin on day 2'''
-'''28-day cycle for 6 cycles; begin each cycle on Day 29 and when ANC ≥ 750/μL, platelets ≥ 75,000/μL, and the patient has been off of myeloid growth factor for at least 24 hours'''
+'''28-day cycle for 6 cycles; begin each cycle on day 29 and when ANC ≥ 750/μL, platelets ≥ 75,000/μL, and the patient has been off of myeloid growth factor for at least 24 hours'''
 </div></div>
 ===References===
@@ Line 202: / Line 202: @@
 ==COG ACNS0334 Protocol A==
 <div class="toccolours" style="background-color:#eeeeee">
-===Induction, 21-Day Cycle for 3 cycles===
+===Induction, 21-day Cycle for 3 cycles===
 {| class="wikitable sortable" style="width: 100%; text-align:center;"
 !style="width: 20%"|Study
@@ Line 224: / Line 224: @@
 *[[Cyclophosphamide (Cytoxan)]] 60 mg/kg IV over 60 minutes once per day on days 1 & 2, given with hyperhydration and mesna
 **Must reduce urine specific gravity to ≤ 1.010 prior to administration and maintain urine output at greater than 3 mL/kg/hour
-*[[Cisplatin (Platinol)]] 3.5 mg/kg IV infusion over 6 hours on Day 3
+*[[Cisplatin (Platinol)]] 3.5 mg/kg IV over 6 hours once on day 3
 **[[Cisplatin (Platinol)]] doses may require the use of mannitol to augment hydration and diuresis
 **Must reduce urine specific gravity to ≤1.010 prior to starting of [[Cisplatin (Platinol)]
 ====Supportive therapy,====
-*[[Mesna (Mesnex)]] 60 mg/kg IV on Days 1, 2, of which the total daily [[Mesna (Mesnex)]] dose is administered in 5 equally divided doses of 12 mg/kg:
+*[[Mesna (Mesnex)]] 12 mg/kg IV five times per day on days 1 & 2
-**Dose 1: Initial bolus dose of mesna may be administered before or at the same time as the [[Cyclophosphamide (Cytoxan)]]
+**Dose 1: Initial bolus dose of may be administered before or at the same time as the [[Cyclophosphamide (Cytoxan)]]
-**Dose 2: A 3-hour infusion of [[Mesna (Mesnex)]] immediately following the [[Cyclophosphamide (Cytoxan)]] infusion (Hours 2 - 5)
+**Dose 2: A 3-hour infusion immediately following the [[Cyclophosphamide (Cytoxan)]] infusion (Hours 2 - 5)
-**Dose 3-5: 3 subsequent [[Mesna (Mesnex)]] bolus doses are given at hours 6, 9, 12, or by institutional protocol
+**Doses 3 to 5: 3 subsequent bolus doses are given at hours 6, 9, 12, or by institutional protocol
 **[[Mesna (Mesnex)]] may also be given as a 24-hour continuous infusion starting 30 minutes before cyclophosphamide and finishing no sooner than 12 hours after the end of the cyclophosphamide infusion, or by institutional protocol
-*[[Filgrastim (Neupogen)]] 5 mcg/kg SubQ or IV (per institutional policy) once daily starting 24-36 hours after Cisplatin infusion and continue until ANC > 1000/μL then increase to 10 mcg/kg and plan for harvest 2 days later. If PBSC harvest after the first cycle is insufficient, then harvests may occur after the second (and third if required) cycle. If PBSC harvest is not planned, continue until ANC > 2000/μL.
+*[[Filgrastim (Neupogen)]] 5 mcg/kg SC or IV (per institutional policy) once per day, starting 24-36 hours after Cisplatin infusion and continue until ANC > 1000/μL then increase to 10 mcg/kg and plan for harvest 2 days later. If PBSC harvest after the first cycle is insufficient, then harvests may occur after the second (and third if required) cycle. If PBSC harvest is not planned, continue until ANC > 2000/μL.
 '''21-day cycle for 3 cycles'''
 </div></div><br>
@@ Line 286: / Line 286: @@
 ====Chemotherapy, induction====
 '''3 cycles'''
-*[[Vincristine (Oncovin)]] 0.05 mg/kg (maximum single dose of 2 mg) IV push over 1 minute or IV infusion (per institution) once on day 1, 8, 15
+*[[Vincristine (Oncovin)]] 0.05 mg/kg (maximum single dose of 2 mg) IV push over 1 minute or IV infusion (per institution) once per day on days 1, 8, 15
-*High Dose [[Methotrexate (MTX)]] 400 mg/kg (20 gram maximum) IV over 4 hours on day 1
+*High Dose [[Methotrexate (MTX)]] 400 mg/kg (20 gram maximum) IV over 4 hours once on day 1
-*[[Etoposide (Vepesid)]] 2.5 mg/kg (maximum concentration of [[Etoposide (Vepesid)]] is 0.4 mg/ml) IV over 1 hour once daily on days A, B, C
+*[[Etoposide (Vepesid)]] 2.5 mg/kg (maximum concentration of [[Etoposide (Vepesid)]] is 0.4 mg/ml) IV over 60 minutes once per day on days A, B, C
 **Day A of chemotherapy begins when the serum [[Methotrexate (MTX)]] level is less than 0.1 micromolar
 **Begin [[Etoposide (Vepesid)]] infusion 1 hour before the Cyclophosphamide or CIS platin infusions
-*[[Cyclophosphamide (Cytoxan)]] 60 mg/kg IV once per day over 1 hour on days A, B
+*[[Cyclophosphamide (Cytoxan)]] 60 mg/kg IV over 60 minutes once per day on days A & B
 **Day A of chemotherapy begins when the serum [[Methotrexate (MTX)]] level is less than 0.1 micromolar
 **Must reduce urine specific gravity to ≤ 1.010 prior to administration and maintain urine output at greater than 3 mL/kg/hour
-*[[Cisplatin (Platinol)]] 3.5 mg/kg IV infusion over 6 hours on day C
+*[[Cisplatin (Platinol)]] 3.5 mg/kg IV over 6 hours once on day C
 **Day A of chemotherapy begins when the serum [[Methotrexate (MTX)]] level is less than 0.1 micromolar
 **[[Cisplatin (Platinol)]] doses may require use of mannitol to augment hydration and diuresis
@@ Line 301: / Line 301: @@
 *[[Folinic acid (Leucovorin)]] 10 mg/m<sup>2</sup> PO or IV every 6 hours until serum [[Methotrexate (MTX)]] levels are less than 0.1 micromolar
 **[[Folinic acid (Leucovorin)]] must be started 24 hours from the beginning of the [[Methotrexate (MTX)]] infusion
-*[[Mesna (Mesnex)]] 12 mg/kg IV on days A, B as described below:
+*[[Mesna (Mesnex)]] 12 mg/kg IV five times per day on days A & B
-**Dose 1:Initial bolus dose of [[Mesna (Mesnex)]] may be administered before or at the same time as the [[Cyclophosphamide (Cytoxan)]]
+**Dose 1: Initial bolus dose of [[Mesna (Mesnex)]] may be administered before or at the same time as the [[Cyclophosphamide (Cytoxan)]]
-**Dose 2:A 3 hour infusion of [[Mesna (Mesnex)]] immediately following the [[Cyclophosphamide (Cytoxan)]] infusion
+**Dose 2: A 3 hour infusion of [[Mesna (Mesnex)]] immediately following the [[Cyclophosphamide (Cytoxan)]] infusion
 **Dose 3 to 5: 3 subsequent [[Mesna (Mesnex)]] bolus doses given at hours 6, 9, 12 or by institutional protocol
 **[[Mesna (Mesnex)]] 60 mg/kg/day may also be given as a 24 hour continuous infusion by institutional protocol
 **Day A of chemotherapy begins when the serum [[Methotrexate (MTX)]] level is less than 0.1 micromolar
-*[[Filgrastim (Neupogen)]] 5 mcg/kg SubQ or IV (per institutional policy) once daily starting on day D (24-36 hours after Cisplatin infusion) and continue until ANC > 1000/μL then increase to 10 mcg/kg and plan for harvest 2 days later. If PBSC harvest after the first cycle is insufficient, then harvests may occur after the second (and third if required) cycle. If PBSC harvest is not planned, continue until ANC > 2000/μL.
+*[[Filgrastim (Neupogen)]] 5 mcg/kg SubQ or IV (per institutional policy) once per day starting on day D (24-36 hours after Cisplatin infusion) and continue until ANC > 1000/μL then increase to 10 mcg/kg and plan for harvest 2 days later. If PBSC harvest after the first cycle is insufficient, then harvests may occur after the second (and third if required) cycle. If PBSC harvest is not planned, continue until ANC > 2000/μL.
 '''21-day course, followed by:'''
 </div></div><br>
@@ Line 329: / Line 329: @@
 ====Chemotherapy, Autologous Transplan====
 '''3 cycles'''
-*[[Carboplatin (Paraplatin)]] 17 mg/kg IV over 2 hours given daily on Days 1 & 2
+*[[Carboplatin (Paraplatin)]] 17 mg/kg IV over 2 hours given once per day on days 1 & 2
 ** If corrected GFR is < 100 ml/min/1.73m<sup>2</sup>, the [[Carboplatin (Paraplatin)]] dose should be calculated using the modified Calvert formula
-*[[Thiotepa (Thioplex)]] 10 mg/kg IV over 2 hours once daily on Days 1 & 2 immediately following [[Carboplatin (Paraplatin)]] administration
+*[[Thiotepa (Thioplex)]] 10 mg/kg IV over 2 hours once per day on days 1 & 2 immediately following [[Carboplatin (Paraplatin)]] administration
 ** Skincare, frequent bathing, and linen changes during [[Thiotepa (Thioplex)]] administration are important and required to avoid chemical skin burns
 *PBSC on day 4
 ====Supportive therapy, Autologous Transplant====
-*[[Filgrastim (Neupogen)]] 5 mcg/kg SubQ or IV (per institutional policy) once daily starting on Day 5 (24 hours after infusion of PBSC) and continue until ANC > 2000/μL
+*[[Filgrastim (Neupogen)]] 5 mcg/kg SubQ or IV (per institutional policy) once per day starting on day 5 (24 hours after infusion of PBSC) and continue until ANC > 2000/μL
 **If [[Filgrastim (Neupogen)]] is given IV, it should be administered by IV bolus over 15 to 30 minutes or by continuous infusion
 '''28-day cycle'''
@@ Line 357: / Line 357: @@
 ====Chemotherapy, induction cycles 1 & 3====
 *[[Cisplatin (Platinol)]] 3.5 mg/kg IV once on day 1
-*[[Vincristine (Oncovin)]] 0.05 mg/kg (maximum dose of 2 mg) IV once on days 1, 8, & 15
+*[[Vincristine (Oncovin)]] 0.05 mg/kg (maximum dose of 2 mg) IV once per day on days 1, 8, 15
-*[[Cyclophosphamide (Cytoxan)]] 55 mg/kg IV once on days 2 & 3
+*[[Cyclophosphamide (Cytoxan)]] 55 mg/kg IV once per day on days 2 & 3
-*[[Etoposide (Vepesid)]] 4 mg/kg IV once daily on days 2 & 3
+*[[Etoposide (Vepesid)]] 4 mg/kg IV once per day on days 2 & 3
 *High Dose [[Methotrexate (MTX)]] 270 mg/kg IV over 4 hours once on day 3
 ====Supportive therapy, induction cycles 1 & 3====
@@ Line 366: / Line 366: @@
 '''15-day cycle'''
 ====Chemotherapy, induction cycles 2 & 4====
-*[[Vincristine (Oncovin)]] 0.05 mg/kg (maximum dose of 2 mg) IV once on days 1, 8, & 15
+*[[Vincristine (Oncovin)]] 0.05 mg/kg (maximum dose of 2 mg) IV once per day on days 1, 8, 15
-*[[Cyclophosphamide (Cytoxan)]] 55 mg/kg IV once on days 2 & 3
+*[[Cyclophosphamide (Cytoxan)]] 55 mg/kg IV once per day on days 2 & 3
-*[[Etoposide (Vepesid)]] 1.65 mg/kg PO once daily on Day 1 to 10
+*[[Etoposide (Vepesid)]] 1.65 mg/kg PO once per day on days 1 to 10
 *[[Temozolomide (Temodar)]] 6.5 mg/kg PO once per day on days 1 to 5
 '''15-day cycles'''
 ====Chemotherapy, induction cycle 5====
 *[[Cisplatin (Platinol)]] 3.5 mg/kg IV once on day 1
-*[[Cyclophosphamide (Cytoxan)]] 55 mg/kg IV once on days 2 & 3
+*[[Cyclophosphamide (Cytoxan)]] 55 mg/kg IV once per day on days 2 & 3
-*[[Etoposide (Vepesid)]] 4 mg/kg IV once daily on days 2 & 3
+*[[Etoposide (Vepesid)]] 4 mg/kg IV once per day on days 2 & 3
 *High Dose [[Methotrexate (MTX)]] 270 mg/kg IV over 4 hours once on day 3
 ====Supportive therapy, induction cycle 5====
@@ Line 381: / Line 381: @@
 '''15-day course; patients with no evidence of disease (NED) after induction or second look surgery proceed to:'''
 ====Chemotherapy, myeloablative with autologous stem cell rescue====
-*[[Carboplatin (Paraplatin)]] AUC of 7/day once daily on days 1 to 3
+*[[Carboplatin (Paraplatin)]] AUC of 7/day once per day on days 1 to 3
-*[[Thiotepa (Thioplex)]] 300 mg/m<sup>2</sup> IV once daily on Days 1 to 3 immediately following [[Carboplatin (Paraplatin)]] administration
+*[[Thiotepa (Thioplex)]] 300 mg/m<sup>2</sup> IV once per day on days 1 to 3 immediately following [[Carboplatin (Paraplatin)]] administration
-*[[Etoposide (Vepesid)]] 250 mg/m<sup>2</sup> IV once daily on Day 1 to 3
+*[[Etoposide (Vepesid)]] 250 mg/m<sup>2</sup> IV once per day on days 1 to 3
 '''3-day course'''
 </div></div>
@@ Line 421: / Line 421: @@
 ====Chemotherapy, High Dose with PBSC support====
 '''4 cycles'''
-*[[Amifostine (Ethyol)]] 600 mg/m<sup>2</sup> IV push over 1 minute given 5 minutes prior to [[Cisplatin (Platinol)]] infusion and 3 hours into [[Cisplatin (Platinol)]] infusion on day -4
+*[[Amifostine (Ethyol)]] 600 mg/m<sup>2</sup> IV push over 1 minute given 5 minutes prior to [[Cisplatin (Platinol)]] infusion and 3 hours into [[Cisplatin (Platinol)]] infusion once on day -4
-*[[Cisplatin (Platinol)]] 75 mg/m<sup>2</sup> IV over 6 hours on day -4
+*[[Cisplatin (Platinol)]] 75 mg/m<sup>2</sup> IV over 6 hours once on day -4
-*[[Vincristine (Oncovin)]] 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push per day on day -4
+*[[Vincristine (Oncovin)]] 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push once per day on days -4 & +6
-*[[Cyclophosphamide (Cytoxan)]] 2000 mg/m<sup>2</sup> IV infusion over 1 hour on days -3, -2
+*[[Cyclophosphamide (Cytoxan)]] 2000 mg/m<sup>2</sup> IV over 60 minutes once per day on days -3 & -2
-*[[Vincristine (Oncovin)]] 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push per day on day 6
 ====Supportive therapy====
-*[[Mesna (Mesnex)]] 500 mg/m<sup>2</sup> IV push 15 minutes prior to [[Cyclophosphamide (Cytoxan)]] infusion on days -3, -2
+*[[Mesna (Mesnex)]] 500 mg/m<sup>2</sup> IV push 15 minutes prior to [[Cyclophosphamide (Cytoxan)]] infusion once per day on days -3 & -2
 *[[Mesna (Mesnex)]] 1500 mg/m<sup>2</sup> IV continuous infusion on days -3, -2
 *PBSC Infusion on day 0
-*[[Filgrastim (Neupogen)]] 5 mcg/kg SubQ or IV (per institutional policy) once daily beginning on day 1 (24-36 hours after PBSC reinfusion) and continue for at least 7 days or continue until ANC > 2000/μL for 2 consecutive days.
+*[[Filgrastim (Neupogen)]] 5 mcg/kg SubQ or IV (per institutional policy) once per day beginning on day 1 (24-36 hours after PBSC reinfusion) and continue for at least 7 days or continue until ANC > 2000/μL for 2 consecutive days.
 '''28-day cycles'''
 </div></div>
@@ Line 459: / Line 458: @@
 ====Chemotherapy, High Dose with PBSC support====
 '''4 cycles'''
-*[[Amifostine (Ethyol)]] 600 mg/m<sup>2</sup> IV push over 1 minute given 5 minutes prior to [[Cisplatin (Platinol)]] infusion and 3 hours into [[Cisplatin (Platinol)]] infusion on day -4
+*[[Amifostine (Ethyol)]] 600 mg/m<sup>2</sup> IV push over 1 minute given 5 minutes prior to [[Cisplatin (Platinol)]] infusion and 3 hours into [[Cisplatin (Platinol)]] infusion once on day -4
-*[[Cisplatin (Platinol)]] 75 mg/m<sup>2</sup> IV over 6 hours on day -4
+*[[Cisplatin (Platinol)]] 75 mg/m<sup>2</sup> IV over 6 hours once on day -4
-*[[Vincristine (Oncovin)]] 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push per day on day -4
+*[[Vincristine (Oncovin)]] 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push once per day on days -4 & +6
-*[[Cyclophosphamide (Cytoxan)]] 2000 mg/m<sup>2</sup> IV infusion over 1 hour on days -3, -2
+*[[Cyclophosphamide (Cytoxan)]] 2000 mg/m<sup>2</sup> IV over 60 minutes once per day on days -3 & -2
-*[[Vincristine (Oncovin)]] 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push per day on day 6
 ====Supportive medications====
-*[[Mesna (Mesnex)]] 500 mg/m<sup>2</sup> IV push 15 minutes prior to [[Cyclophosphamide (Cytoxan)]] infusion on days -3, -2
+*[[Mesna (Mesnex)]] 500 mg/m<sup>2</sup> IV push 15 minutes prior to [[Cyclophosphamide (Cytoxan)]] infusion once per day on days -3 & -2
-*[[Mesna (Mesnex)]] 1500 mg/m<sup>2</sup> IV continuous infusion on days -3, -2
+*[[Mesna (Mesnex)]] 1500 mg/m<sup>2</sup> IV continuous infusion on days -3 & -2
 *PBSC Infusion on day 0
-*[[Filgrastim (Neupogen)]] 5 mcg/kg SubQ or IV (per institutional policy) once daily beginning on day 1 (24-36 hours after PBSC reinfusion) and continue for at least 7 days or continue until ANC > 2000/μL for 2 consecutive days.
+*[[Filgrastim (Neupogen)]] 5 mcg/kg SubQ or IV (per institutional policy) once per day beginning on day 1 (24-36 hours after PBSC reinfusion) and continue for at least 7 days or continue until ANC > 2000/μL for 2 consecutive days.
 '''28-day cycles'''
 </div></div>

Difference between revisions of "Medulloblastoma"

Revision as of 03:27, 15 April 2023

Guidelines

EANO/EURACAN

Upfront Therapy Older Children

COG ACNS0331 Standard Dose CSRT with Reduced Volume Boost to Tumor Bed

Protocol

Radiotherapy, induction portion

Chemotherapy, induction portion

Chemotherapy, maintenance part A (Cycles 1, 2, 4, 5, 7, 8)(6 weeks=1 cycle)

Chemotherapy, maintenance part B (Cycles 3, 6, 9)(4 weeks=1 cycle)

Supportive therapy, maintenance part B (Cycles 3, 6, 9)(4 weeks=1 cycle)

References

COG ACNS0331 Standard Dose CSRT with Standard Volume Boost

Protocol

Radiotherapy, induction portion

Chemotherapy, induction portion

Chemotherapy, maintenance part A (Cycles 1, 2, 4, 5, 7, 8)(6 weeks=1 cycle)

Chemotherapy, maintenance part B (Cycles 3, 6, 9)(4 weeks=1cycle)

Supportive therapy, maintenance part B (Cycles 3, 6, 9)(4 weeks=1 cycle)

References

COG ACNS0332 Protocol A

Protocol

Radiotherapy, induction

Chemotherapy, induction

Chemotherapy, maintenance

References

COG ACNS0332 Protocol B

Protocol

Radiotherapy, induction

Chemotherapy, induction

Chemotherapy, maintenance

References

Upfront Therapy, Younger Children

COG ACNS0334 Protocol A

Induction, 21-day Cycle for 3 cycles

Chemotherapy

Supportive therapy,

Consolidation, 28-day cycle for 3 cycles

Chemotherapy, Autologous Transplant

Supportive therapy, Autologous Transplant

References

COG ACNS0334 Protocol B

Induction

Chemotherapy, induction

Supportive therapy, induction

Consolidation

Chemotherapy, Autologous Transplan

Supportive therapy, Autologous Transplant

References

Head Start III Protocol D2

Protocol

Chemotherapy, induction cycles 1 & 3

Supportive therapy, induction cycles 1 & 3

Chemotherapy, induction cycles 2 & 4

Chemotherapy, induction cycle 5

Supportive therapy, induction cycle 5

Chemotherapy, myeloablative with autologous stem cell rescue

References

SJMB-96 Protocol High Risk

Protocol

Chemotherapy

Supportive therapy

Radiotherapy

Chemotherapy, High Dose with PBSC support

Supportive therapy

References

SJMB-96 Protocol Average Risk

Protocol

Growth factor therapy

Radiotherapy

Chemotherapy, High Dose with PBSC support

Supportive medications

References

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