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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2006 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00024336
First received: September 13, 2001
Last updated: February 6, 2009
Last verified: December 2006
History of Changes

September 13, 2001
February 6, 2009
August 1999
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Complete list of historical versions of study NCT00024336 on ClinicalTrials.gov Archive Site
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Radiation Therapy and Tamoxifen in Treating Children With Newly Diagnosed Brain Stem Glioma
Treatment of Children With Newly Diagnosed Diffuse Pontine Gliomas Using Conventional Radiotherapy and High Dose Tamoxifen

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.

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.
Interventional
Phase 2
Primary Purpose: Treatment
Brain and Central Nervous System Tumors
  • Drug: tamoxifen citrate
  • Radiation: radiation therapy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
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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
Both
up to 19 Years
No
Contact information is only displayed when the study is recruiting subjects
Ireland,   United Kingdom
 
NCT00024336
CDR0000068920, CCLG-CNS-1999-06, EU-20123
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Children's Cancer and Leukaemia Group
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Study Chair: Anthony Michalski, MD Great Ormond Street Hospital for Children NHS Foundation Trust
National Cancer Institute (NCI)
December 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP