Radiation Therapy and Tamoxifen in Treating Children With Newly Diagnosed Brain Stem Glioma
NCT ID: NCT00024336
Last Updated: 2013-08-07
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
INTERVENTIONAL
1999-08-31
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of combining radiation therapy and tamoxifen in treating children who have newly diagnosed brain stem glioma.
Detailed Description
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* Determine whether high-dose tamoxifen with radiotherapy increases the median survival and overall survival of children with newly diagnosed brain stem gliomas.
* Determine the time to neurologic or radiographic progression in patients treated with this regimen.
* Determine the acute and chronic toxicity of high-dose tamoxifen in these patients.
OUTLINE: This is a multicenter study.
Patients undergo radiotherapy once daily 5 days a week for 6 weeks. Within 2 weeks after the initiation of radiotherapy, patients receive oral high-dose tamoxifen once daily. Tamoxifen continues in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: Approximately 60 patients will be accrued for this study within 4 years.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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tamoxifen citrate
radiation therapy
Eligibility Criteria
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Inclusion Criteria
* Newly diagnosed tumor of the brain stem (diffuse intrinsic lesion centered on the pons)
* Radiological and clinical diagnostic criteria allowed (biopsy not required)
* The following astrocytic tumors are allowed if histologically confirmed:
* Diffuse astrocytoma (all subtypes)
* Anaplastic astrocytoma
* Glioblastoma
* Pilocytic astrocytoma (grade I)
* Less than 6 months since diagnosis
* At least 1 of the following signs of brain stem tumor:
* Cranial nerve deficit
* Long tract signs
* Ataxia
* No focal lesions of the brain stem (either clearly marginated or cystic), cervicomedullary tumors, tumors predominately exophytic, or pontine tumors diagnosed as pilocytic on biopsy
PATIENT CHARACTERISTICS:
Age:
* Under 20
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Not specified
Renal:
* Not specified
Other:
* Not pregnant or nursing
* No frequent vomiting or other medical condition that would preclude oral medication intake
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* No prior chemotherapy for brain stem glioma
Endocrine therapy:
* Concurrent steroids allowed
Radiotherapy:
* No prior radiotherapy for brain stem glioma
Surgery:
* Not specified
Other:
* Concurrent anticonvulsants allowed
19 Years
ALL
No
Sponsors
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Children's Cancer and Leukaemia Group
OTHER
Principal Investigators
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Anthony Michalski, MD
Role: STUDY_CHAIR
Great Ormond Street Hospital for Children NHS Foundation Trust
Locations
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Our Lady's Hospital for Sick Children
Crumlin, , Ireland
Birmingham Children's Hospital
Birmingham, England, United Kingdom
Bristol Royal Hospital for Children
Bristol, England, United Kingdom
Addenbrooke's NHS Trust
Cambridge, England, United Kingdom
St. James's Hospital
Leeds, England, United Kingdom
Leicester Royal Infirmary
Leicester, England, United Kingdom
Royal Liverpool Children's Hospital, Alder Hey
Liverpool, England, United Kingdom
Saint Bartholomew's Hospital
London, England, United Kingdom
Hospital for Sick Children NHS Trust
London, England, United Kingdom
Middlesex Hospital- Meyerstein Institute
London, England, United Kingdom
Manchester Children's Hospitals (NHS Trust)
Manchester, England, United Kingdom
Newcastle Upon Tyne Hospitals NHS Trust
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 Hospital
Sutton, England, United Kingdom
Royal Belfast Hospital for Sick Children
Belfast, Northern Ireland, United Kingdom
Aberdeen Royal Infirmary
Aberdeen, Scotland, United Kingdom
Royal Hospital for Sick Children
Edinburgh, Scotland, United Kingdom
Royal Hospital for Sick Children
Glasgow, Scotland, United Kingdom
Llandough Hospital
Penarth, Wales, United Kingdom
Countries
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Other Identifiers
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CDR0000068920
Identifier Type: REGISTRY
Identifier Source: secondary_id
EU-20123
Identifier Type: -
Identifier Source: secondary_id
CCLG-CNS-1999-06
Identifier Type: -
Identifier Source: org_study_id