This trial is active, not recruiting.

Condition brain and central nervous system tumors
Treatments tamoxifen citrate, radiation therapy
Phase phase 2
Sponsor Children's Cancer and Leukaemia Group
Start date August 1999
Trial identifier NCT00024336, CCLG-CNS-1999-06, CDR0000068920, EU-20123


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Primary purpose treatment

Eligibility Criteria

Male or female participants up to 19 years old.

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

Additional Information

Official title Treatment of Children With Newly Diagnosed Diffuse Pontine Gliomas Using Conventional Radiotherapy and High Dose Tamoxifen
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2013.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).