Radiation Therapy and Tamoxifen in Treating Children With Newly Diagnosed Brain Stem Glioma
|ClinicalTrials.gov Identifier: NCT00024336|
Recruitment Status : Unknown
Verified December 2006 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : August 7, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors||Drug: tamoxifen citrate Radiation: radiation therapy||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Treatment of Children With Newly Diagnosed Diffuse Pontine Gliomas Using Conventional Radiotherapy and High Dose Tamoxifen|
|Study Start Date :||August 1999|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00024336
|Our Lady's Hospital for Sick Children|
|Crumlin, Ireland, 12|
|Birmingham Children's Hospital|
|Birmingham, England, United Kingdom, B4 6NH|
|Bristol Royal Hospital for Children|
|Bristol, England, United Kingdom, BS2 8BJ|
|Addenbrooke's NHS Trust|
|Cambridge, England, United Kingdom, CB2 2QQ|
|St. James's Hospital|
|Leeds, England, United Kingdom, LS9 7TF|
|Leicester Royal Infirmary|
|Leicester, England, United Kingdom, LE1 5WW|
|Royal Liverpool Children's Hospital, Alder Hey|
|Liverpool, England, United Kingdom, L12 2AP|
|Saint Bartholomew's Hospital|
|London, England, United Kingdom, EC1A 7BE|
|Hospital for Sick Children NHS Trust|
|London, England, United Kingdom, WC1N 3JH|
|Middlesex Hospital- Meyerstein Institute|
|London, England, United Kingdom, WIT 3AA|
|Manchester Children's Hospitals (NHS Trust)|
|Manchester, England, United Kingdom, M27 1HA|
|Newcastle Upon Tyne Hospitals NHS Trust|
|Newcastle-Upon-Tyne, England, United Kingdom, NE7 7DN|
|Queen's Medical Centre|
|Nottingham, England, United Kingdom, NG7 2UH|
|Oxford Radcliffe Hospital|
|Oxford, England, United Kingdom, 0X3 9DU|
|Children's Hospital - Sheffield|
|Sheffield, England, United Kingdom, S10 2TH|
|Southampton General Hospital|
|Southampton, England, United Kingdom, SO16 6YD|
|Royal Marsden Hospital|
|Sutton, England, United Kingdom, SM2 5PT|
|Royal Belfast Hospital for Sick Children|
|Belfast, Northern Ireland, United Kingdom, BT12 6BE|
|Aberdeen Royal Infirmary|
|Aberdeen, Scotland, United Kingdom, AB25 2ZN|
|Royal Hospital for Sick Children|
|Edinburgh, Scotland, United Kingdom|
|Royal Hospital for Sick Children|
|Glasgow, Scotland, United Kingdom, G3 8SJ|
|Penarth, Wales, United Kingdom, CF64 2XX|
|Study Chair:||Anthony Michalski, MD||Great Ormond Street Hospital for Children NHS Foundation Trust|