Back to resultsRadiation Therapy and Tamoxifen in Treating Children With Newly Diagnosed Brain Stem Glioma
Primary Purpose
Brain and Central Nervous System Tumors
Status
Unknown status
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
tamoxifen citrate
radiation therapy
Sponsored by
About this trial
This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring untreated childhood brain stem glioma
Eligibility 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
Sites / Locations
- Our Lady's Hospital for Sick Children
- Birmingham Children's Hospital
- Bristol Royal Hospital for Children
- Addenbrooke's NHS Trust
- St. James's Hospital
- Leicester Royal Infirmary
- Royal Liverpool Children's Hospital, Alder Hey
- Saint Bartholomew's Hospital
- Hospital for Sick Children NHS Trust
- Middlesex Hospital- Meyerstein Institute
- Manchester Children's Hospitals (NHS Trust)
- Newcastle Upon Tyne Hospitals NHS Trust
- Queen's Medical Centre
- Oxford Radcliffe Hospital
- Children's Hospital - Sheffield
- Southampton General Hospital
- Royal Marsden Hospital
- Royal Belfast Hospital for Sick Children
- Aberdeen Royal Infirmary
- Royal Hospital for Sick Children
- Royal Hospital for Sick Children
- Llandough Hospital
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00024336
First Posted
September 13, 2001
Last Updated
August 6, 2013
Sponsor
Children's Cancer and Leukaemia Group
1. Study Identification
Unique Protocol Identification Number
NCT00024336
Brief Title
Radiation Therapy and Tamoxifen in Treating Children With Newly Diagnosed Brain Stem Glioma
Official Title
Treatment of Children With Newly Diagnosed Diffuse Pontine Gliomas Using Conventional Radiotherapy and High Dose Tamoxifen
Study Type
Interventional
2. Study Status
Record Verification Date
December 2006
Overall Recruitment Status
Unknown status
Study Start Date
August 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Children's Cancer and Leukaemia Group
4. Oversight
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors
Keywords
untreated childhood brain stem glioma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
tamoxifen citrate
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
10. Eligibility
Sex
All
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Michalski, MD
Organizational Affiliation
Great Ormond Street Hospital for Children NHS Foundation Trust
Official's Role
Study Chair
Facility Information:
Facility Name
Our Lady's Hospital for Sick Children
City
Crumlin
ZIP/Postal Code
12
Country
Ireland
Facility Name
Birmingham Children's Hospital
City
Birmingham
State/Province
England
ZIP/Postal Code
B4 6NH
Country
United Kingdom
Facility Name
Bristol Royal Hospital for Children
City
Bristol
State/Province
England
ZIP/Postal Code
BS2 8BJ
Country
United Kingdom
Facility Name
Addenbrooke's NHS Trust
City
Cambridge
State/Province
England
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
Facility Name
St. James's Hospital
City
Leeds
State/Province
England
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Leicester Royal Infirmary
City
Leicester
State/Province
England
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
Royal Liverpool Children's Hospital, Alder Hey
City
Liverpool
State/Province
England
ZIP/Postal Code
L12 2AP
Country
United Kingdom
Facility Name
Saint Bartholomew's Hospital
City
London
State/Province
England
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
Hospital for Sick Children NHS Trust
City
London
State/Province
England
ZIP/Postal Code
WC1N 3JH
Country
United Kingdom
Facility Name
Middlesex Hospital- Meyerstein Institute
City
London
State/Province
England
ZIP/Postal Code
WIT 3AA
Country
United Kingdom
Facility Name
Manchester Children's Hospitals (NHS Trust)
City
Manchester
State/Province
England
ZIP/Postal Code
M27 1HA
Country
United Kingdom
Facility Name
Newcastle Upon Tyne Hospitals NHS Trust
City
Newcastle-Upon-Tyne
State/Province
England
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Queen's Medical Centre
City
Nottingham
State/Province
England
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Facility Name
Oxford Radcliffe Hospital
City
Oxford
State/Province
England
ZIP/Postal Code
0X3 9DU
Country
United Kingdom
Facility Name
Children's Hospital - Sheffield
City
Sheffield
State/Province
England
ZIP/Postal Code
S10 2TH
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southampton
State/Province
England
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Royal Marsden Hospital
City
Sutton
State/Province
England
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Royal Belfast Hospital for Sick Children
City
Belfast
State/Province
Northern Ireland
ZIP/Postal Code
BT12 6BE
Country
United Kingdom
Facility Name
Aberdeen Royal Infirmary
City
Aberdeen
State/Province
Scotland
ZIP/Postal Code
AB25 2ZN
Country
United Kingdom
Facility Name
Royal Hospital for Sick Children
City
Edinburgh
State/Province
Scotland
Country
United Kingdom
Facility Name
Royal Hospital for Sick Children
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G3 8SJ
Country
United Kingdom
Facility Name
Llandough Hospital
City
Penarth
State/Province
Wales
ZIP/Postal Code
CF64 2XX
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Radiation Therapy and Tamoxifen in Treating Children With Newly Diagnosed Brain Stem Glioma
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