Medulloblastoma

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

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

Chemoradiotherapy

XRT

• 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

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

7-week course

References

1. COG ACNS0331: Michalski JM, Janss AJ, Vezina LG, Smith KS, Billups CA, Burger PC, Embry LM, Cullen PL, Hardy PC, Pomeroy SL, Bass JK, Perkins SM, Merchant TE, Colte PD, Fitzgerald TJ, JBooth 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. Journal of Clinical Oncology 39, no. 24 (August 20, 2021) 2685-2697. link to original article NCT00085735

Maintenance Regimen A

Cycles 1, 2, 4, 5, 7, 8

Chemotherapy

• 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, and 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.

6-week cycle

References

1. COG ACNS0331: Michalski JM, Janss AJ, Vezina LG, Smith KS, Billups CA, Burger PC, Embry LM, Cullen PL, Hardy PC, Pomeroy SL, Bass JK, Perkins SM, Merchant TE, Colte PD, Fitzgerald TJ, JBooth 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. Journal of Clinical Oncology 39, no. 24 (August 20, 2021) 2685-2697. link to original article NCT00085735

Maintenance Regimen B

Cycles 3, 6, and 9

Chemotherapy

• Cyclophosphamide (Cytoxan) 1000 mg/m² IV given over 1 hour on Days 1 and 2.
• Mesna (Mesnex) 360 mg/m²/dose IV over 15 to 30 minutes on Days 1 and 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 15-30 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.
• Vincristine (Oncovin) 1.5 mg/m² (maximum dose of 2 mg) IV once per day on days 1, and 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.

6-week course

References

1. COG ACNS0331: Michalski JM, Janss AJ, Vezina LG, Smith KS, Billups CA, Burger PC, Embry LM, Cullen PL, Hardy PC, Pomeroy SL, Bass JK, Perkins SM, Merchant TE, Colte PD, Fitzgerald TJ, JBooth 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. Journal of Clinical Oncology 39, no. 24 (August 20, 2021) 2685-2697. link to original article NCT00085735

COG ACNS0331 Standard Dose CSRT/Standard Volume Boost

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

Chemoradiotherapy

XRT

• 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

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

7-week course

References

1. COG ACNS0331: Michalski JM, Janss AJ, Vezina LG, Smith KS, Billups CA, Burger PC, Embry LM, Cullen PL, Hardy PC, Pomeroy SL, Bass JK, Perkins SM, Merchant TE, Colte PD, Fitzgerald TJ, JBooth 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. Journal of Clinical Oncology 39, no. 24 (August 20, 2021) 2685-2697. link to original article NCT00085735

Maintenance Regimen A

Cycles 1, 2, 4, 5, 7, 8

Chemotherapy

• 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, and 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.

6-week cycle

References

1. COG ACNS0331: Michalski JM, Janss AJ, Vezina LG, Smith KS, Billups CA, Burger PC, Embry LM, Cullen PL, Hardy PC, Pomeroy SL, Bass JK, Perkins SM, Merchant TE, Colte PD, Fitzgerald TJ, JBooth 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. Journal of Clinical Oncology 39, no. 24 (August 20, 2021) 2685-2697. link to original article NCT00085735

Maintenance Regimen B

Cycles 3, 6, and 9

Chemotherapy

• Cyclophosphamide (Cytoxan) 1000 mg/m² IV given over 1 hour on Days 1 and 2.
• Mesna (Mesnex) 360 mg/m²/dose IV over 15 to 30 minutes on Days 1 and 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 15-30 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.
• Vincristine (Oncovin) 1.5 mg/m² (maximum dose of 2 mg) IV once per day on days 1, and 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.

6-week course

References

1. COG ACNS0331: Michalski JM, Janss AJ, Vezina LG, Smith KS, Billups CA, Burger PC, Embry LM, Cullen PL, Hardy PC, Pomeroy SL, Bass JK, Perkins SM, Merchant TE, Colte PD, Fitzgerald TJ, JBooth 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. Journal of Clinical Oncology 39, no. 24 (August 20, 2021) 2685-2697. link to original article NCT00085735

COG ACNS0332 Regimen A

Chemoradiotherapy

XRT

• 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 full protocol as this depends on site of metastases and disease stage. 

Chemotherapy

• Vincristine (Oncovin) 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute or IV infusion (per institution) once on day 1, 8, 15, 22, 29, and 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

References

1. COG ACNS0332: Hwang EI, Kool M, Capper D, Chavez L, Brabetz S, Williams-Hughes C, Billups C, Heier L, Jaju A, Michalski J, Li Y, Leary S, Zhou T, von Deimling A, Jones DTW, Fouladi M, Pollack IF, Gajjar A, Packer RJ, Pfister SM, Olson JM. Extensive Molecular and Clinical Heterogeneity in Patients with Histologically Diagnosed CNS-PNET Treated as a Single Entity: A Report From the Children's Oncology Group Randomized ACNS0332 Trial. Journal of Clinical Oncology 2018 Oct 17:JCO2017764720. link to original article NCT00392327
2. COG ACNS0332: Leary SES, Packer RJ, LiY, 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 Oncology 2021 Sep 1; 7(9): 1313-1321. link to original article NCT00392327

Maintenance Cycle

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 for a total of 6 cycles.

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 (per institution) once on days 1 and 8.
  • Round vincristine down to the nearest 0.1 mg.
• Cyclophosphamide (Cytoxan) 1000 mg/m² IV over 1 hour once on days 2 and 3.
  • Cyclophosphamide (Cytoxan) should be given at least 24 hours after Cisplatin on day 2.

28-Day Course

References

1. COG ACNS0332: Hwang EI, Kool M, Capper D, Chavez L, Brabetz S, Williams-Hughes C, Billups C, Heier L, Jaju A, Michalski J, Li Y, Leary S, Zhou T, von Deimling A, Jones DTW, Fouladi M, Pollack IF, Gajjar A, Packer RJ, Pfister SM, Olson JM. Extensive Molecular and Clinical Heterogeneity in Patients with Histologically Diagnosed CNS-PNET Treated as a Single Entity: A Report From the Children's Oncology Group Randomized ACNS0332 Trial. Journal of Clinical Oncology 2018 Oct 17:JCO2017764720. link to original article NCT00392327
2. COG ACNS0332: Leary SES, Packer RJ, LiY, 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 Oncology 2021 Sep 1; 7(9): 1313-1321. link to original article NCT00392327

COG ACNS0332 Regimen B

Chemoradiotherapy

XRT

• 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 full protocol as this depends on site of metastases and disease stage. 

Chemotherapy

• Vincristine (Oncovin) 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute or IV infusion (per institution) once on day 1, 8, 15, 22, 29, and 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 given daily 1 - 4 hours prior to radiation therapy (Total of 30 doses).
  • Carboplatin (Paraplatin) first dose administered on the first day of radiation therapy.
  • Carboplatin (Paraplatin) should be HELD if radiation treatment is not given.
  • Since there are 31 fractions of radiation, No Carboplatin (Paraplatin) should be given prior to the final radiation fraction.

6-Week Course

1. COG ACNS0332: Hwang EI, Kool M, Capper D, Chavez L, Brabetz S, Williams-Hughes C, Billups C, Heier L, Jaju A, Michalski J, Li Y, Leary S, Zhou T, von Deimling A, Jones DTW, Fouladi M, Pollack IF, Gajjar A, Packer RJ, Pfister SM, Olson JM. Extensive Molecular and Clinical Heterogeneity in Patients with Histologically Diagnosed CNS-PNET Treated as a Single Entity: A Report From the Children's Oncology Group Randomized ACNS0332 Trial. Journal of Clinical Oncology 2018 Oct 17:JCO2017764720. link to original article NCT00392327
2. COG ACNS0332: Leary SES, Packer RJ, LiY, 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 Oncology 2021 Sep 1; 7(9): 1313-1321. link to original article NCT00392327

Maintenance Cycle

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 for a total of 6 cycles.

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 (per institution) once on days 1 and 8.
  • Round vincristine down to the nearest 0.1 mg.
• Cyclophosphamide (Cytoxan) 1000 mg/m² IV over 1 hour once on days 2 and 3.
  • Cyclophosphamide (Cytoxan) should be given at least 24 hours after Cisplatin on day 2.

28-Day Course

References

1. COG ACNS0332: Hwang EI, Kool M, Capper D, Chavez L, Brabetz S, Williams-Hughes C, Billups C, Heier L, Jaju A, Michalski J, Li Y, Leary S, Zhou T, von Deimling A, Jones DTW, Fouladi M, Pollack IF, Gajjar A, Packer RJ, Pfister SM, Olson JM. Extensive Molecular and Clinical Heterogeneity in Patients with Histologically Diagnosed CNS-PNET Treated as a Single Entity: A Report From the Children's Oncology Group Randomized ACNS0332 Trial. Journal of Clinical Oncology 2018 Oct 17:JCO2017764720. link to original article NCT00392327
2. COG ACNS0332: Leary SES, Packer RJ, LiY, 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 Oncology 2021 Sep 1; 7(9): 1313-1321. link to original article NCT00392327

Adjuvant therapy

Carboplatin, Cyclophosphamide, Etoposide, Methotrexate, Vincristine

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Regimen

Study	Evidence
Rutkowski et al. 2005	Non-randomized

Preceding treatment

• Surgery

Chemotherapy

• Carboplatin (Paraplatin)
• Cyclophosphamide (Cytoxan)
• Etoposide (Vepesid)
• Methotrexate (MTX)
• Vincristine (Oncovin)

References

1. Rutkowski S, Bode U, Deinlein F, Ottensmeier H, Warmuth-Metz M, Soerensen N, Graf N, Emser A, Pietsch T, Wolff JE, Kortmann RD, Kuehl J. Treatment of early childhood medulloblastoma by postoperative chemotherapy alone. N Engl J Med. 2005 Mar 10;352(10):978-86. link to original article PubMed

Cisplatin, Lomustine, Vincristine

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Regimen

Study	Years of enrollment	Evidence	Comparator	Comparative Efficacy
Packer et al. 2006 (COG A9961)	1996-2000	Phase 3 (C)	Cisplatin, Cyclophosphamide, Vincristine	Did not meet primary endpoint of EFS

Note: neither the cycle length nor the exact dosing instructions for vincristine are clear from the manuscript.

Preceding treatment

• Surgery, then radiotherapy

Chemotherapy

• Cisplatin (Platinol) 75 mg/m² IV once on day 1
• Lomustine (CCNU) 75 mg/m² PO once on day 0
• Vincristine (Oncovin) 1.5 mg/m² (maximum dose of 2 mg) IV once per day on days 1, 7, 14

8 cycles (see note)

References

1. COG A9961: Packer RJ, Gajjar A, Vezina G, Rorke-Adams L, Burger PC, Robertson PL, Bayer L, LaFond D, Donahue BR, Marymont MH, Muraszko K, Langston J, Sposto R. Phase III study of craniospinal radiation therapy followed by adjuvant chemotherapy for newly diagnosed average-risk medulloblastoma. J Clin Oncol. 2006 Sep 1;24(25):4202-8. link to original article contains partially verified protocol PubMed NCT00002875

Cyclophosphamide & Vincristine/Cisplatin & Etoposide

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Protocol

Study	Evidence
Duffner et al. 1993	Non-randomized

Total duration of treatment is 12 to 24 months.

Preceding treatment

• Surgical resection or biopsy

Chemotherapy, part 1

• Cyclophosphamide (Cytoxan)
• Vincristine (Oncovin)

28-day cycle for 2 cycles, alternating with part 2

Chemotherapy, part 2

• Cisplatin (Platinol)
• Etoposide (Vepesid)

28-day cycle for 1 cycle, alternating with part 1

References

1. Duffner PK, Horowitz ME, Krischer JP, Friedman HS, Burger PC, Cohen ME, Sanford RA, Mulhern RK, James HE, Freeman CR, Seidel FG, Kun LE. Postoperative chemotherapy and delayed radiation in children less than three years of age with malignant brain tumors. N Engl J Med. 1993 Jun 17;328(24):1725-31. link to original article PubMed

VCP

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VCP: Vincristine, CCNU (Lomustine), Prednisone

Regimen

Study	Years of enrollment	Evidence	Comparator	Comparative Efficacy
Zeltzer et al. 1999 (CCG-921)	1986-1992	Phase 3 (C)	8-in-1	Superior PFS

Preceding treatment

• Surgery, then Vincristine & RT

Chemotherapy

• Vincristine (Oncovin) 1.5 mg/m² IV once per day on days 1, 8, 15
• Lomustine (CCNU) 100 mg/m² IV once on day 1
• Prednisone (Sterapred) 40 mg/m² PO once per day on days 1 to 14

6-week cycle for 8 cycles

References

1. CCG-921: Zeltzer PM, Boyett JM, Finlay JL, Albright AL, Rorke LB, Milstein JM, Allen JC, Stevens KR, Stanley P, Li H, Wisoff JH, Geyer JR, McGuire-Cullen P, Stehbens JA, Shurin SB, Packer RJ. Metastasis stage, adjuvant treatment, and residual tumor are prognostic factors for medulloblastoma in children: conclusions from the Children's Cancer Group 921 randomized phase III study. J Clin Oncol. 1999 Mar;17(3):832-45. link to original article contains verified protocol PubMed