Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	Under 20	Other	CCLG-CNS-1999-06 EU-20123, NCT00024336

Objectives

1. Determine whether high-dose tamoxifen with radiotherapy increases the median survival and overall survival of children with newly diagnosed brain stem gliomas.
2. Determine the time to neurologic or radiographic progression in patients treated with this regimen.
3. Determine the acute and chronic toxicity of high-dose tamoxifen in these patients.

Entry 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

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

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

Expected Enrollment

Approximately 60 patients will be accrued for this study within 4 years.

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.

Trial Contact Information

Trial Lead Organizations

Children's Cancer and Leukaemia Group

Anthony Michalski, MD, Protocol chair		Ph: 44-20-7829-7924 Email: michaa@gosh.nhs.uk

Registry Information
Official Title		Treatment of Children with Newly Diagnosed Diffuse Pontine Gliomas Using Conventional Radiotherapy and High Dose Tamoxifen
Trial Start Date		1999-08-01
Registered in ClinicalTrials.gov		NCT00024336
Date Submitted to PDQ		2001-07-30
Information Last Verified		2006-12-11

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