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

Brain and Central Nervous System Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00024336
• Other study ID #: CCLG-CNS-1999-06
• Secondary ID: CDR0000068920EU-
• Status: Active, not recruiting
• Phase: Phase 2
• First received: September 13, 2001
• Last updated: August 6, 2013
• Start date: August 1999

Study information

• Verified date: December 2006
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 19 Years

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Nervous System Neoplasms

Intervention

Drug:
• tamoxifen citrate

Radiation:
• radiation therapy

Locations

Country	Name	City	State
Ireland	Our Lady's Hospital for Sick Children	Crumlin
United Kingdom	Aberdeen Royal Infirmary	Aberdeen	Scotland
United Kingdom	Royal Belfast Hospital for Sick Children	Belfast	Northern Ireland
United Kingdom	Birmingham Children's Hospital	Birmingham	England
United Kingdom	Bristol Royal Hospital for Children	Bristol	England
United Kingdom	Addenbrooke's NHS Trust	Cambridge	England
United Kingdom	Royal Hospital for Sick Children	Edinburgh	Scotland
United Kingdom	Royal Hospital for Sick Children	Glasgow	Scotland
United Kingdom	St. James's Hospital	Leeds	England
United Kingdom	Leicester Royal Infirmary	Leicester	England
United Kingdom	Royal Liverpool Children's Hospital, Alder Hey	Liverpool	England
United Kingdom	Hospital for Sick Children NHS Trust	London	England
United Kingdom	Middlesex Hospital- Meyerstein Institute	London	England
United Kingdom	Saint Bartholomew's Hospital	London	England
United Kingdom	Manchester Children's Hospitals (NHS Trust)	Manchester	England
United Kingdom	Newcastle Upon Tyne Hospitals NHS Trust	Newcastle-Upon-Tyne	England
United Kingdom	Queen's Medical Centre	Nottingham	England
United Kingdom	Oxford Radcliffe Hospital	Oxford	England
United Kingdom	Llandough Hospital	Penarth	Wales
United Kingdom	Children's Hospital - Sheffield	Sheffield	England
United Kingdom	Southampton General Hospital	Southampton	England
United Kingdom	Royal Marsden Hospital	Sutton	England

Sponsors (1)

Lead Sponsor	Collaborator
Children's Cancer and Leukaemia Group

Countries where clinical trial is conducted

Ireland,  United Kingdom,