Difference between revisions of "Medulloblastoma"

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===Consolidation===
 
===Consolidation===
 
*[[Carboplatin (Paraplatin)]] 17 mg/kg/day IV over 2 hours given daily on Days 1 and 2
 
*[[Carboplatin (Paraplatin)]] 17 mg/kg/day IV over 2 hours given daily on Days 1 and 2
−
** If corrected GFR is < 100 ml/min/1.73m^2, the [[Carboplatin (Paraplatin)]] dose should be calculated using the modified Calvert formula
+
** If corrected GFR is < 100 ml/min/1.73m<sup>2<, the [[Carboplatin (Paraplatin)]] dose should be calculated using the modified Calvert formula
  
 
====References====
 
====References====

Revision as of 23:24, 13 April 2022

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Upfront Therapy

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

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, 43 (Once a week starting one week after CSRT begins)
    • Round vincristine down to the nearest 0.1 mg

7-week course

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)
  • 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

6-week cycle


Maintenance Regimen B

Cycles 3, 6, and 9

Chemotherapy

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

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, 43 (Once a week starting one week after CSRT begins)
    • Round vincristine down to the nearest 0.1 mg

7-week course

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)
  • 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

6-week cycle

Maintenance Regimen B

Cycles 3, 6, and 9

Chemotherapy

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

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

  • 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, 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

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

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

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

  • 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, 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 to 4 hours prior to radiation therapy (Total of 30 doses)

6-Week Course

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

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 ACNS0334 Regimen A

Induction

Chemotherapy

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
  • Cyclophosphamide (Cytoxan) 60 mg/kg IV over 1 hour (Hour 1-2) on Days 1, 2 with hyperhydration and Mesna (Mesnex)
    • Must reduce urine specific gravity to ≤ 1.010 prior to administration and maintain urine output at greater than 3 mL/kg/hour
  • 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:
    • Dose 1: Initial bolus dose of mesna 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 3-5: 3 subsequent Mesna (Mesnex) 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
  • Cisplatin (Platinol) 3.5 mg/kg IV infusion over 6 hours 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)]

21 Day Course

Consolidation

References

  1. COG ACNS0334: P.D. Aridgides, G. Kang, C. Mazewski, T.E. Merchant. Outcomes after Radiation Therapy for Very Young Children with High-Risk Medulloblastoma or Supratentorial Primitive Neuroectodermal Tumor Treated on COG ACNS0334. Radiation Oncology 105, no. 1 (September 1, 2019)link to original article NCT00336024

COG ACNS0334 Regimen B

Induction

Chemotherapy

3 Cycles

21 Day Course

References
  1. COG ACNS0334: P.D. Aridgides, G. Kang, C. Mazewski, T.E. Merchant. Outcomes after Radiation Therapy for Very Young Children with High-Risk Medulloblastoma or Supratentorial Primitive Neuroectodermal Tumor Treated on COG ACNS0334. Radiation Oncology 105, no. 1 (September 1, 2019)link to original article NCT00336024

Consolidation

Chemotherapy

References
  1. COG ACNS0334: P.D. Aridgides, G. Kang, C. Mazewski, T.E. Merchant. Outcomes after Radiation Therapy for Very Young Children with High-Risk Medulloblastoma or Supratentorial Primitive Neuroectodermal Tumor Treated on COG ACNS0334. Radiation Oncology 105, no. 1 (September 1, 2019)link to original article NCT00336024

Adjuvant therapy

Carboplatin, Cyclophosphamide, Etoposide, Methotrexate, Vincristine

back to top

Regimen

Study Evidence
Rutkowski et al. 2005 Non-randomized

Preceding treatment

Chemotherapy

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

Chemotherapy

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

back to top

Protocol

Study Evidence
Duffner et al. 1993 Non-randomized

Total duration of treatment is 12 to 24 months.

Preceding treatment

Chemotherapy, part 1

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

Chemotherapy, part 2

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

back to top

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

Chemotherapy

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
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