Official Title: “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.

Study Type: Interventional

Study Design: Treatment

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.

Intervention(s) in this Clinical Trial

• Drug: tamoxifen citrate
• Procedure: radiation therapy

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: 19 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Children's Cancer and Leukaemia Group

Overall Clinical Trial Officials and Contacts

Anthony Michalski, MD Study Chair Great Ormond Street Hospital for Children  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00024336

Study ID Number: CDR0000068920

ClinicalTrials.gov Identifier: NCT00024336

Health Authority: United States: Federal Government

Clinical trial summary from the National Cancer Institute's PDQ® database