High-Dose Methotrexate in Treating Young Patients With Residual Ependymoma
- Conditions
- Brain and Central Nervous System Tumors
- Registration Number
- NCT00287924
- Lead Sponsor
- Children's Cancer and Leukaemia Group
- Brief Summary
RATIONALE: Drugs used in chemotherapy, such as methotrexate, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well high-dose methotrexate works in treating young patients with residual ependymoma.
- Detailed Description
OBJECTIVES:
Primary
* Determine the activity of high-dose methotrexate as upfront-window therapy in young patients with residual ependymoma.
Secondary
* 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 29
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Activity of high-dose methotrexate at 6 weeks
- Secondary Outcome Measures
Name Time Method Assess reasons why primary surgery is complete or incomplete at diagnosis Feasibility and toxicity of second look surgery after course 3 at 2 months Compare functional imaging studies of ependymomas with biological characteristics of the tumors at diagnosis
Trial Locations
- Locations (20)
Our Lady's Hospital for Sick Children Crumlin
🇮🇪Dublin, Ireland
Birmingham Children's Hospital
🇬🇧Birmingham, England, United Kingdom
Institute of Child Health at University of Bristol
🇬🇧Bristol, England, United Kingdom
Addenbrooke's Hospital
🇬🇧Cambridge, England, United Kingdom
Leeds Cancer Centre at St. James's University Hospital
🇬🇧Leeds, England, United Kingdom
Leicester Royal Infirmary
🇬🇧Leicester, England, United Kingdom
Royal Liverpool Children's Hospital, Alder Hey
🇬🇧Liverpool, England, United Kingdom
Royal London Hospital
🇬🇧London, England, United Kingdom
Great Ormond Street Hospital for Children
🇬🇧London, England, United Kingdom
Royal Manchester Children's Hospital
🇬🇧Manchester, England, United Kingdom
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