High-Dose Methotrexate in Treating Young Patients With Residual Ependymoma
NCT ID: NCT00287924
Last Updated: 2013-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
29 participants
INTERVENTIONAL
2005-03-31
Brief Summary
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PURPOSE: This phase II trial is studying how well high-dose methotrexate works in treating young patients with residual ependymoma.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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TREATMENT
NONE
Interventions
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methotrexate
adjuvant therapy
Eligibility Criteria
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Exclusion Criteria
* Subependymomas
* Ependymoblastomas
* Primitive neuroectodermal tumors (PNETs)
* Other neuroepithelial tumors
* Choroid plexus tumors
* Germ cell tumors
* Residual measurable ependymoma after maximal surgical resection, including second-look surgery, if deemed necessary
* Has undergone surgical resection within the past 3 weeks
PATIENT CHARACTERISTICS:
* At least 3 months to under 3 years of age
* Neutrophil count \> 1,000/mm\^3
* Platelet count \> 100,000/mm\^3
* Able to tolerate chemotherapy
* No co-existent unrelated disease (i.e., renal or hematological) that would preclude chemotherapy treatment
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* Recovered from prior surgery
* No previous chemotherapy
* Previous steroids allowed
* No previous radiotherapy
2 Years
ALL
No
Sponsors
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Children's Cancer and Leukaemia Group
OTHER
Principal Investigators
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Martin W. English, MD
Role: STUDY_CHAIR
Birmingham Children's Hospital
Locations
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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
Sir James Spence Institute of Child Health at Royal Victoria Infirmary
Newcastle upon Tyne, England, United Kingdom
Queen's Medical Centre
Nottingham, England, United Kingdom
Oxford Radcliffe Hospital
Oxford, England, United Kingdom
Children's Hospital - Sheffield
Sheffield, England, United Kingdom
Southampton General Hospital
Southampton, England, United Kingdom
Royal Marsden - Surrey
Sutton, England, United Kingdom
Royal Belfast Hospital for Sick Children
Belfast, Northern Ireland, United Kingdom
Royal Aberdeen Children's Hospital
Aberdeen, Scotland, United Kingdom
Royal Hospital for Sick Children
Edinburgh, Scotland, United Kingdom
Royal Hospital for Sick Children
Glasgow, Scotland, United Kingdom
Childrens Hospital for Wales
Cardiff, Wales, United Kingdom
Countries
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Other Identifiers
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CCLG-CNS-2005-03
Identifier Type: -
Identifier Source: secondary_id
EU-20581
Identifier Type: -
Identifier Source: secondary_id
EUDRACT-2004-004405-14
Identifier Type: -
Identifier Source: secondary_id
CDR0000454548
Identifier Type: -
Identifier Source: org_study_id