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Treatment of Children With Newly Diagnosed Diffuse Pontine Gliomas Using Conventional Radiotherapy and High Dose Tamoxifen


Phase 2
N/A
19 Years
Open (Enrolling)
Both
Brain and Central Nervous System Tumors

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Trial Information

Treatment of Children With Newly Diagnosed Diffuse Pontine Gliomas Using Conventional Radiotherapy and High Dose Tamoxifen


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Anthony Michalski, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Great Ormond Street Hospital for Children NHS Foundation Trust

Authority:

United States: Federal Government

Study ID:

CDR0000068920

NCT ID:

NCT00024336

Start Date:

August 1999

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • untreated childhood brain stem glioma
  • Glioma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

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