High-Dose Methotrexate in Treating Young Patients With Residual Ependymoma
Recruitment status was Active, not recruiting
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.
Brain and Central Nervous System Tumors
Procedure: adjuvant therapy
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of High-Dose Methotrexate in Children With Residual Ependymoma|
- Activity of high-dose methotrexate at 6 weeks [ Designated as safety issue: No ]
- Assess reasons why primary surgery is complete or incomplete at diagnosis [ Designated as safety issue: No ]
- Feasibility and toxicity of second look surgery after course 3 at 2 months [ Designated as safety issue: Yes ]
- Compare functional imaging studies of ependymomas with biological characteristics of the tumors at diagnosis [ Designated as safety issue: No ]
|Study Start Date:||March 2005|
|Estimated Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00287924
|Our Lady's Hospital for Sick Children Crumlin|
|Dublin, Ireland, 12|
|Birmingham Children's Hospital|
|Birmingham, England, United Kingdom, B4 6NH|
|Institute of Child Health at University of Bristol|
|Bristol, England, United Kingdom, BS2 8AE|
|Cambridge, England, United Kingdom, CB2 2QQ|
|Leeds Cancer Centre at St. James's University Hospital|
|Leeds, England, United Kingdom, LS9 7TF|
|Leicester Royal Infirmary|
|Leicester, England, United Kingdom, LE1 5WW|
|Royal Liverpool Children's Hospital, Alder Hey|
|Liverpool, England, United Kingdom, L12 2AP|
|Royal London Hospital|
|London, England, United Kingdom, E1 1BB|
|Great Ormond Street Hospital for Children|
|London, England, United Kingdom, WC1N 3JH|
|Royal Manchester Children's Hospital|
|Manchester, England, United Kingdom, M27 4HA|
|Sir James Spence Institute of Child Health at Royal Victoria Infirmary|
|Newcastle-Upon-Tyne, England, United Kingdom, NE1 4LP|
|Queen's Medical Centre|
|Nottingham, England, United Kingdom, NG7 2UH|
|Oxford Radcliffe Hospital|
|Oxford, England, United Kingdom, 0X3 9DU|
|Children's Hospital - Sheffield|
|Sheffield, England, United Kingdom, S10 2TH|
|Southampton General Hospital|
|Southampton, England, United Kingdom, SO16 6YD|
|Royal Marsden - Surrey|
|Sutton, England, United Kingdom, SM2 5PT|
|Royal Belfast Hospital for Sick Children|
|Belfast, Northern Ireland, United Kingdom, BT12 6BE|
|Royal Aberdeen Children's Hospital|
|Aberdeen, Scotland, United Kingdom, AB25 2ZG|
|Royal Hospital for Sick Children|
|Edinburgh, Scotland, United Kingdom, EH9 1LF|
|Royal Hospital for Sick Children|
|Glasgow, Scotland, United Kingdom, G3 8SJ|
|Childrens Hospital for Wales|
|Cardiff, Wales, United Kingdom, CF14 4XW|
|Study Chair:||Martin W. English, MD||Birmingham Children's Hospital|