Phase II Study of High-Dose Methotrexate in Children With Residual Ependymoma
- Determine the activity of high-dose methotrexate as upfront-window therapy in young
patients with residual ependymoma.
- Assess the reasons why primary surgery was complete/incomplete in these patients.
- Assess the feasibility and toxicity of second-look surgery after 3 courses of high-dose
methotrexate in cases where initial surgery was incomplete.
OUTLINE: This is a multicenter, open-label study.
Patients receive high-dose methotrexate IV continuously over 24 hours on days 0, 14, and 28
in the absence of disease progression or unacceptable toxicity. Patients then proceed to
further chemotherapy on protocol UKCCSG-CNS-9204.
After completion of study treatment, patients are followed periodically for 9 years.
PROJECTED ACCRUAL: A total of 29 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Activity of high-dose methotrexate at 6 weeks
Martin W. English, MD
Birmingham Children's Hospital
United States: Federal Government