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

Children's Cancer and Leukaemia Group

Status and phase: Unknown; Phase 2

Conditions: Brain and Central Nervous System Tumors

Treatments: Drug: tamoxifen citrate; Radiation: radiation therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00024336

EU-20123

CCLG-CNS-1999-06

CDR0000068920 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: Under 19 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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