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

This study is ongoing, but not recruiting participants.

Sponsored by: Children's Cancer and Leukaemia Group
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00024336
  Purpose

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 Intervention Phase
Brain and Central Nervous System Tumors
Drug: tamoxifen citrate
Procedure: radiation therapy
Phase II

MedlinePlus related topics:   Cancer   

ChemIDplus related topics:   Tamoxifen    Tamoxifen citrate    Citric acid    Sodium Citrate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Treatment of Children With Newly Diagnosed Diffuse Pontine Gliomas Using Conventional Radiotherapy and High Dose Tamoxifen

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   August 1999

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
Ages Eligible for Study:   up to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS:

  • 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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00024336

Locations
Ireland
Our Lady's Hospital for Sick Children    
      Crumlin, Ireland, 12
United Kingdom, England
Addenbrooke's NHS Trust    
      Cambridge, England, United Kingdom, CB2 2QQ
Birmingham Children's Hospital    
      Birmingham, England, United Kingdom, B4 6NH
Bristol Royal Hospital for Children    
      Bristol, England, United Kingdom, BS2 8BJ
Children's Hospital - Sheffield    
      Sheffield, England, United Kingdom, S10 2TH
Oxford Radcliffe Hospital    
      Oxford, England, United Kingdom, 0X3 9DU
Leicester Royal Infirmary    
      Leicester, England, United Kingdom, LE1 5WW
Manchester Children's Hospitals (NHS Trust)    
      Manchester, England, United Kingdom, M27 1HA
Middlesex Hospital- Meyerstein Institute    
      London, England, United Kingdom, WIT 3AA
Newcastle Upon Tyne Hospitals NHS Trust    
      Newcastle-Upon-Tyne, England, United Kingdom, NE7 7DN
Hospital for Sick Children NHS Trust    
      London, England, United Kingdom, WC1N 3JH
Queen's Medical Centre    
      Nottingham, England, United Kingdom, NG7 2UH
Royal Liverpool Children's Hospital, Alder Hey    
      Liverpool, England, United Kingdom, L12 2AP
Royal Marsden Hospital    
      Sutton, England, United Kingdom, SM2 5PT
Saint Bartholomew's Hospital    
      London, England, United Kingdom, EC1A 7BE
Southampton General Hospital    
      Southampton, England, United Kingdom, SO16 6YD
St. James's Hospital    
      Leeds, England, United Kingdom, LS9 7TF
United Kingdom, Northern Ireland
Royal Belfast Hospital for Sick Children    
      Belfast, Northern Ireland, United Kingdom, BT12 6BE
United Kingdom, Scotland
Aberdeen Royal Infirmary    
      Aberdeen, Scotland, United Kingdom, AB25 2ZN
Royal Hospital for Sick Children    
      Glasgow, Scotland, United Kingdom, G3 8SJ
Royal Hospital for Sick Children    
      Edinburgh, Scotland, United Kingdom
United Kingdom, Wales
Llandough Hospital    
      Penarth, Wales, United Kingdom, CF64 2XX

Sponsors and Collaborators
Children's Cancer and Leukaemia Group

Investigators
Study Chair:     Anthony Michalski, MD     Great Ormond Street Hospital for Children    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000068920, CCLG-CNS-1999-06, EU-20123
First Received:   September 13, 2001
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00024336
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
untreated childhood brain stem glioma  

Study placed in the following topic categories:
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Citric Acid
Neuroepithelioma
Glioma
Central Nervous System Neoplasms
Tamoxifen
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Estrogen Antagonists
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Nervous System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Bone Density Conservation Agents
Selective Estrogen Receptor Modulators
Pharmacologic Actions
Estrogen Receptor Modulators
Neoplasms
Neoplasms by Site
Therapeutic Uses
Neoplasms, Neuroepithelial

ClinicalTrials.gov processed this record on September 23, 2008




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