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| ID | Type | Description | Link |
|---|---|---|---|
| CCLG-CNS-2005-03 | |||
| EU-20581 | |||
| EUDRACT-2004-004405-14 |
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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.
OBJECTIVES:
Primary
Secondary
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| methotrexate | Drug | |||
| adjuvant therapy | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Activity of high-dose methotrexate at 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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DISEASE CHARACTERISTICS:
Histologically confirmed ependymoma, including the following histologic variants:
The following diagnoses are excluded:
Residual measurable ependymoma after maximal surgical resection, including second-look surgery, if deemed necessary
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Martin W. English, MD | Birmingham Children's Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Our Lady's Hospital for Sick Children Crumlin | Dublin | 12 | Ireland | |||
| Birmingham Children's Hospital |
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| Birmingham |
| England |
| B4 6NH |
| United Kingdom |
| Institute of Child Health at University of Bristol | Bristol | England | BS2 8AE | United Kingdom |
| Addenbrooke's Hospital | Cambridge | England | CB2 2QQ | United Kingdom |
| Leeds Cancer Centre at St. James's University Hospital | Leeds | England | LS9 7TF | United Kingdom |
| Leicester Royal Infirmary | Leicester | England | LE1 5WW | United Kingdom |
| Royal Liverpool Children's Hospital, Alder Hey | Liverpool | England | L12 2AP | United Kingdom |
| Royal London Hospital | London | England | E1 1BB | United Kingdom |
| Great Ormond Street Hospital for Children | London | England | WC1N 3JH | United Kingdom |
| Royal Manchester Children's Hospital | Manchester | England | M27 4HA | United Kingdom |
| Sir James Spence Institute of Child Health at Royal Victoria Infirmary | Newcastle upon Tyne | England | NE1 4LP | United Kingdom |
| Queen's Medical Centre | Nottingham | England | NG7 2UH | United Kingdom |
| Oxford Radcliffe Hospital | Oxford | England | 0X3 9DU | United Kingdom |
| Children's Hospital - Sheffield | Sheffield | England | S10 2TH | United Kingdom |
| Southampton General Hospital | Southampton | England | SO16 6YD | United Kingdom |
| Royal Marsden - Surrey | Sutton | England | SM2 5PT | United Kingdom |
| Royal Belfast Hospital for Sick Children | Belfast | Northern Ireland | BT12 6BE | United Kingdom |
| Royal Aberdeen Children's Hospital | Aberdeen | Scotland | AB25 2ZG | United Kingdom |
| Royal Hospital for Sick Children | Edinburgh | Scotland | EH9 1LF | United Kingdom |
| Royal Hospital for Sick Children | Glasgow | Scotland | G3 8SJ | United Kingdom |
| Childrens Hospital for Wales | Cardiff | Wales | CF14 4XW | United Kingdom |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D008727 | Methotrexate |
| D017024 | Chemotherapy, Adjuvant |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
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