Medulloblastoma

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Last updated on 2024-07-23:
9 regimens on this page
9 variants on this page


Guidelines

Given the rapid change in evidence in many areas of hematology/oncology, readers are encouraged to consider any guideline published 5+ years ago to be for historical purposes, only.

EANO/EURACAN


NCCN


Upfront therapy, older children

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

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.

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

Induction

Radiotherapy

Chemotherapy

  • Vincristine (Oncovin) 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute or IV infusion 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:


Maintenance

Chemotherapy, first portion (cycles 1, 2, 4, 5, 7, 8; "Part A")

  • Cisplatin (Platinol) 75 mg/m2 IV once on day 1
  • Lomustine (CCNU) 75 mg/m2 PO once on day 1, taken on an empty stomach (at least 2 hours after food) preferably at bedtime (reduce N/V)
      • Pediatric Lomustine Dosing Chart
      • Give lomustine 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, second portion (cycles 3, 6, 9; "Part B")

  • 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, second portion (cycles 3, 6, 9; "Part B")

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

42-day cycle for 2 cycles, then 28-day course, then 42-day cycle for 2 cycles, then 28-day course, then 42-day cycle for 2 cycles, then 28-day course (9 cycles total; AAB-AAB-AAB)

References

  1. 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

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

Induction

Radiotherapy

Chemotherapy

  • Vincristine (Oncovin) 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute or IV infusion 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:


Maintenance

Chemotherapy, first portion (cycles 1, 2, 4, 5, 7, 8; "Part A")

  • Cisplatin (Platinol) 75 mg/m2 IV once on day 1
  • Lomustine (CCNU) 75 mg/m2 PO once on day 1, taken on an empty stomach (at least 2 hours after food) preferably at bedtime (reduce N/V)
      • Pediatric Lomustine Dosing Chart
      • Give lomustine 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, second portion (cycles 3, 6, 9; "Part B")

  • 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, second portion (cycles 3, 6, 9; "Part B")

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

42-day cycle for 2 cycles, then 28-day course, then 42-day cycle for 2 cycles, then 28-day course, then 42-day cycle for 2 cycles, then 28-day course (9 cycles total; AAB-AAB-AAB)

References

  1. 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

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

Induction

Chemotherapy

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

Radiotherapy

  • Craniospinal External beam radiotherapy 180 cGy per day on days 1 to 5, 8 to 12, 15 to 19, 22 to 26 (3600 cGy in 20 daily fractions)
  • Posterior Fossa Boost External beam radiotherapy 180 cGy per day on days 29 to 33, 36 to 40, 43 (1980 cGy in 11 daily fractions; cumulative dose of 5580 cGy)
    • 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

6-week course, followed by:


Maintenance

Chemotherapy

  • 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 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 at least 750/μL, platelets at least 75,000/μL, and the patient has been off of myeloid growth factor for at least 24 hours

References

  1. 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

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

Induction

Chemotherapy

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

Radiotherapy

  • Craniospinal External beam radiotherapy 180 cGy per day on days 1 to 5, 8 to 12, 15 to 19, 22 to 26 (3600 cGy in 20 daily fractions)
  • Posterior Fossa Boost External beam radiotherapy 180 cGy per day on days 29 to 33, 36 to 40, 43 (1980 cGy in 11 daily fractions; cumulative dose of 5580 cGy)
    • 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

6-week course, followed by:


Maintenance

Chemotherapy

  • 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 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 at least 750/μL, platelets at least 75,000/μL, and the patient has been off of myeloid growth factor for at least 24 hours

References

  1. 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

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Awaiting publication (COG ACNS0334) 2007 to not reported Phase 3 (C) COG ACNS0334 Protocol B (HD-MTX) TBD if different primary endpoint of CR rate

Induction

Chemotherapy

  • Vincristine (Oncovin) 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute or IV infusion once per day on days 1, 8, 15
  • Etoposide (Vepesid) 2.5 mg/kg (maximum concentration is 0.4 mg/ml) IV over 60 minutes once per day on days 1, 2, 3, given 1 hour before cyclophosphamide or cisplatin 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 less than or equal 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
    • Doses may require the use of mannitol to augment hydration and diuresis
    • Must reduce urine specific gravity to less than or equal to1.010 prior to starting cisplatin

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
    • Dose 2: A 3-hour infusion immediately after the cyclophosphamide infusion (Hours 2 - 5)
    • Doses 3 to 5: 3 subsequent bolus doses are given at hours 6, 9, 12, or by institutional protocol
    • Mesna 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 greater than 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 greater than 2000/μL.

21-day cycle for 3 cycles


Consolidation, autologous HSCT

Chemotherapy

  • 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 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 after carboplatin administration
    • Skincare, frequent bathing, and linen changes during administration are important and required to avoid chemical skin burns
  • PBSC on day 4

Supportive therapy

  • 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 greater than 2000/μL
    • If 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

  1. COG ACNS0334: NCT00336024


COG ACNS0334 Protocol B

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Awaiting publication (COG ACNS0334) 2007 to not reported Phase 3 (E-esc) COG ACNS0334 Protocol A (no HD-MTX) TBD if different primary endpoint of CR rate

Induction

Chemotherapy

  • Vincristine (Oncovin) 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute or IV infusion once per day on days 1, 8, 15
  • High Dose Methotrexate (MTX) 400 mg/kg (maximum dose of 20,000 mg) IV over 4 hours once on day 1
  • Etoposide (Vepesid) 2.5 mg/kg (maximum concentration is 0.4 mg/ml) IV over 60 minutes once per day on days A, B, C, given 1 hour before cyclophosphamide or cisplatin infusions
    • Day A of chemotherapy begins when the serum MTX level is less than 0.1 micromolar
  • Cyclophosphamide (Cytoxan) 60 mg/kg IV over 60 minutes once per day on days A & B
    • Day A of chemotherapy begins when the serum MTX level is less than 0.1 micromolar
    • Must reduce urine specific gravity to less than or equal 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 MTX level is less than 0.1 micromolar
    • Doses may require use of mannitol to augment hydration and diuresis
    • Must reduce urine specific gravity to less than or equal to 1.010 prior to administration and maintain urine output at greater than 3 mL/kg/hour

Supportive therapy

  • Leucovorin (Folinic acid) 10 mg/m2 PO or IV every 6 hours until serum methotrexate levels are less than 0.1 micromolar, started 24 hours from the beginning of the methotrexate infusion
  • Mesna (Mesnex) 12 mg/kg IV five times per day on days A & B
    • Dose 1: Initial bolus dose may be administered before or at the same time as cyclophosphamide
    • Dose 2: A 3 hour infusion immediately after cyclophosphamide infusion
    • Dose 3 to 5: 3 subsequent bolus doses given at hours 6, 9, 12 or by institutional protocol
    • Alternative dosing: 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 MTX level is less than 0.1 micromolar
  • Filgrastim (Neupogen) 5 mcg/kg SC or IV (per institutional policy) once per day starting on day D (24-36 hours after Cisplatin infusion) and continue until ANC greater than 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 greater than 2000/μL.

21-day cycle for 3 cycles, followed by:


Consolidation, Autologous HSCT

Chemotherapy

  • 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 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 after carboplatin administration
    • Skincare, frequent bathing, and linen changes during administration are important and required to avoid chemical skin burns
  • PBSC on day 4

Supportive therapy

  • 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 continued until ANC greater than 2000/μL
    • If 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

  1. COG ACNS0334: NCT00336024


Head Start III Protocol D2

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

Induction

Chemotherapy, A portion (cycles 1 & 3)

Supportive therapy, A portion (cycles 1 & 3)

  • Leucovorin (Folinic acid) 10 mg/m2 PO or IV every 6 hours until serum methotrexate levels are less than 0.1 micromolar, started 24 hours from the beginning of the methotrexate infusion

Chemotherapy, B portion (cycles 2 & 4)

Chemotherapy, C portion (cycle 5)

Supportive therapy, C portion (cycle 5)

  • Leucovorin (Folinic acid) 10 mg/m2 PO or IV every 6 hours until serum methotrexate levels are less than 0.1 micromolar, started 24 hours from the beginning of the methotrexate infusion

15-day cycle for 5 cycles; patients with no evidence of disease (NED) after induction or second look surgery proceed to:


Consolidation

Chemotherapy, myeloablative with autologous stem cell rescue

Supportive therapy

One course

References

  1. 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

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

Induction

Chemotherapy

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

Supportive therapy

  • Filgrastim (Neupogen) 10 mcg/kg SC or IV (per institutional policy) mobilization prior to PBSC harvest
    • PBSC harvest after first cycle, or second cycle if first PBSC is inadequate

14-day cycle for 2 cycles


Definitive therapy

Radiotherapy

  • Craniospinal axis External beam radiotherapy by the following stage-based criteria:
    • M0 or M1: 3600 cGy in 18 daily fractions
    • M2 or M3: 36 to 3960 cGy in 18 to 22 daily fractions
      • See protocol for additional details on dose
  • Posterior fossa External beam radiotherapy 5580 cGy in 31 daily fractions
    • Local boost External beam radiotherapy to 5940 cGy in 33 daily fractions at investigator's option for residual tumor measuring > 1.5 cm2

~ 6 week duration, followed in 6 weeks by:


Consolidation

Chemotherapy, High Dose with PBSC support

Supportive therapy

  • Amifostine (Ethyol) 600 mg/m2 IV push over 1 minute given 5 minutes prior to cisplatin infusion and 3 hours into cisplatin infusion once on day -4
  • Mesna (Mesnex) 500 mg/m2 IV push 15 minutes prior to cyclophosphamide 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 SC 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 greater than 2000/μL for 2 consecutive days.

28-day cycle for 4 cycles

References

  1. 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 analysis: 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

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

Mobilization

Growth factor therapy


Definitive therapy

Radiotherapy

~ 6 week duration, followed in 6 weeks by:


Consolidation

Chemotherapy, High Dose with PBSC support

Supportive medications

  • Amifostine (Ethyol) 600 mg/m2 IV push over 1 minute given 5 minutes prior to cisplatin infusion and 3 hours into cisplatin infusion once on day -4
  • Mesna (Mesnex) 500 mg/m2 IV push 15 minutes prior to cyclophosphamide 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 SC 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 greater than 2000/μL for 2 consecutive days.

28-day cycle for 4 cycles

References

  1. 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 analysis: 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


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