Observing Young Patients With Ependymoma Undergoing Standard Combination Chemotherapy
NCT ID: NCT00683319
Last Updated: 2013-09-20
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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ACTIVE_NOT_RECRUITING
50 participants
OBSERVATIONAL
2008-04-30
Brief Summary
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PURPOSE: This phase III trial is observing young patients with ependymoma undergoing standard combination chemotherapy.
Detailed Description
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Primary
* To determine the overall survival and event-free survival of all infants diagnosed with ependymoma before their third birthday.
* To determine the overall survival and event-free survival of infants diagnosed with ependymoma before their third birthday when treated with standard chemotherapy comprising vincristine, carboplatin, high-dose methotrexate, cyclophosphamide, and cisplatin.
Secondary
* To investigate the reasons why the primary tumor was completely resected in patients who were able to undergo complete resection of the tumor.
* To continue to investigate the biological characteristics of ependymoma.
* To correlate functional imaging studies of ependymoma with biological characteristics of the tumor.
* To provide a standard treatment regimen for patients with residual disease after optimal surgery who have already participated in a phase II study.
* To prospectively document renal function, hearing, and neurocognitive late effects after completion of study treatment.
OUTLINE: This is a multicenter study. Patients are stratified according to extent of prior surgical resection and presence of metastatic disease (complete resection of tumor vs metastatic disease at diagnosis vs no complete resection of tumor).
Patients receive vincristine IV on days 1, 15, and 29, carboplatin IV over 1 hour on day 1, high-dose methotrexate\* IV over 24 hours on day 15, cyclophosphamide IV over 1 hour on day 29, and cisplatin IV over 48 hours on days 43 and 44. Treatment repeats every 8 weeks for 7 courses in the absence of disease progression or unacceptable toxicity. Patients with residual disease after completion of treatment may receive other treatment at the discretion of the investigator.
NOTE: \*Patients initially treated on clinical trial CCLG-CNS-2005-03 who have no residual disease do not receive high-dose methotrexate in courses 5-7.
Patients undergo observational assessments comprising physical and neurological examination; MRI/ MRS scanning of the head and spine; and audiology, renal, endocrine, neurocognitive, and quality of life evaluations periodically for at least 5 years after the completion of study treatment.
Conditions
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Keywords
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Interventions
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carboplatin
cisplatin
cyclophosphamide
methotrexate
vincristine sulfate
adjuvant therapy
cognitive assessment
magnetic resonance imaging
magnetic resonance spectroscopic imaging
quality-of-life assessment
Eligibility Criteria
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Inclusion Criteria
* Patients who are unable to tolerate chemotherapy or who do not receive treatment according to the CCLG guidelines for ependymoma due to parental preference or recommendation from the treating physician are eligible
PATIENT CHARACTERISTICS:
* Able to tolerate IV hydration
* No active infection
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
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: PRINCIPAL_INVESTIGATOR
Birmingham Children's Hospital
Locations
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Birmingham Children's Hospital
Birmingham, England, United Kingdom
Addenbrooke's Hospital
Cambridge, England, United Kingdom
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom
Royal Liverpool Children's Hospital, Alder Hey
Liverpool, England, United Kingdom
Great Ormond Street Hospital for Children
London, England, United Kingdom
Royal Manchester Children's Hospital
Manchester, England, United Kingdom
Queen's Medical Centre
Nottingham, England, United Kingdom
Children's Hospital - Sheffield
Sheffield, England, United Kingdom
Aberdeen Royal Infirmary
Aberdeen, Scotland, United Kingdom
Royal Hospital for Sick Children
Glasgow, Scotland, United Kingdom
Countries
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Other Identifiers
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CCLG-CNS-2007-09
Identifier Type: -
Identifier Source: secondary_id
EU-20835
Identifier Type: -
Identifier Source: secondary_id
CDR0000590666
Identifier Type: -
Identifier Source: org_study_id