Spots Global Cancer Trial Database for Radiation Therapy and Tamoxifen in Treating Children With Newly Diagnosed Brain Stem Glioma
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Trial Identification
Brief Title: Radiation Therapy and Tamoxifen in Treating Children With Newly Diagnosed Brain Stem Glioma
Official Title: Treatment of Children With Newly Diagnosed Diffuse Pontine Gliomas Using Conventional Radiotherapy and High Dose Tamoxifen
Study ID: NCT00024336
Conditions
Study Description
Brief Summary: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Tamoxifen may kill tumor cells by blocking the enzymes necessary for cell growth. Combining radiation therapy with tamoxifen may be effective in treating newly diagnosed brain stem glioma. 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: OBJECTIVES: * 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.
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Contact Details
Name: Anthony Michalski, MD
Affiliation: Great Ormond Street Hospital for Children NHS Foundation Trust
Role: STUDY_CHAIR
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