High-grade glioma, pediatric

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Seema Nagpal, MD
Stanford University
Palo Alto, CA

This page contains studies that are specific to pediatric populations. For the more general high-grade glioma category page, follow this link.

4 regimens on this page
5 variants on this page


Adjuvant therapy

Temozolomide & RT

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Temozolomide & RT: Temozolomide & Radiation Therapy

Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Grill et al. 2018 (HERBY) 2011-2015 Randomized Phase II (C) Temozolomide, Bevacizumab, RT Did not meet primary endpoint of EFS

Preceding treatment

Chemotherapy

  • Temozolomide (Temodar) as follows:
    • Cycle 1: 75 mg/m2 PO or IV once per day
    • Cycles 2 to 13: 150 to 200 mg/m2 PO once per day on days 1 to 5

Radiotherapy

  • Concurrent radiation therapy as follows:
    • Cycle 1: 1.80 Gy fractions x 30 fractions, for a total dose of 54 Gy

6-week course, then 4-week break, then 28-day cycle for up to 12 cycles

References

  1. HERBY: Grill J, Massimino M, Bouffet E, Azizi AA, McCowage G, Cañete A, Saran F, Le Deley MC, Varlet P, Morgan PS, Jaspan T, Jones C, Giangaspero F, Smith H, Garcia J, Elze MC, Rousseau RF, Abrey L, Hargrave D, Vassal G. Phase II, open-label, randomized, multicenter trial (HERBY) of bevacizumab in pediatric patients with newly diagnosed high-grade glioma. J Clin Oncol. 2018 Apr 1;36(10):951-958. Epub 2018 Feb 7. link to original article contains verified protocol PubMed NCT01390948

Recurrent disease, non-curative therapy, non-randomized or retrospective data

Temozolomide monotherapy

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Regimen variant #2, 11 cycles

Study Evidence
Nicholson et al. 2007 Non-randomized

Chemotherapy

  • Temozolomide (Temodar) 150 to 200 mg/m2 PO once per day on days 1 to 5
    • Patients who previously received craniospinal irradiation (CSI) instead received 180 mg/m2 PO once per day on days 1 to 5

28-day cycle for up to 11 cycles

References

  1. Nicholson HS, Kretschmar CS, Krailo M, Bernstein M, Kadota R, Fort D, Friedman H, Harris MB, Tedeschi-Blok N, Mazewski C, Sato J, Reaman GH; Children's Oncology Group. Phase 2 study of temozolomide in children and adolescents with recurrent central nervous system tumors: a report from the Children's Oncology Group. Cancer. 2007 Oct 1;110(7):1542-50. link to original article contains verified protocol PubMed