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Radiation Therapy and Tamoxifen in Treating Children With Newly Diagnosed Brain Stem Glioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Drug: tamoxifen citrate Radiation: radiation therapy Phase 2

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Treatment of Children With Newly Diagnosed Diffuse Pontine Gliomas Using Conventional Radiotherapy and High Dose Tamoxifen
Study Start Date : August 1999

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • Under 20

Performance status:

  • Not specified

Life expectancy:

  • Not specified


  • Not specified


  • Not specified


  • Not specified


  • Not pregnant or nursing
  • No frequent vomiting or other medical condition that would preclude oral medication intake


Biologic therapy:

  • Not specified


  • No prior chemotherapy for brain stem glioma

Endocrine therapy:

  • Concurrent steroids allowed


  • No prior radiotherapy for brain stem glioma


  • Not specified


  • Concurrent anticonvulsants allowed

Information from the National Library of Medicine

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 identifier (NCT number): NCT00024336

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Our Lady's Hospital for Sick Children
Crumlin, Ireland, 12
United Kingdom
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
Llandough Hospital
Penarth, Wales, United Kingdom, CF64 2XX
Sponsors and Collaborators
Children's Cancer and Leukaemia Group
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Study Chair: Anthony Michalski, MD Great Ormond Street Hospital for Children NHS Foundation Trust

Layout table for additonal information Identifier: NCT00024336     History of Changes
Other Study ID Numbers: CCLG-CNS-1999-06
CDR0000068920 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: August 7, 2013
Last Verified: December 2006
Keywords provided by National Cancer Institute (NCI):
untreated childhood brain stem glioma
Additional relevant MeSH terms:
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Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents