Brain and Central Nervous System TumorsPhase 2NCT00024336
Radiation Therapy and Tamoxifen in Treating Children With Newly Diagnosed Brain Stem Glioma
A Phase 2 study testing tamoxifen citrate and radiation therapy in people with Brain and Central Nervous System Tumors, run by Children's Cancer and Leukaemia Group at 22 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages Up to 19 years
- Conditions the study is for
- Brain and Central Nervous System Tumors
- What is being tested?
- tamoxifen citrate and radiation therapy
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 22 sitesin 2 countries
- Study dates
- Aug 1999to not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
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
Trial locations and contacts
22 sites in 2 countries.
22 sites in 2 countries
United Kingdom21 sites
Aberdeen Royal Infirmary
Aberdeen, Scotland, AB25 2ZN
Royal Belfast Hospital for Sick Children
Belfast, Northern Ireland, BT12 6BE
Birmingham Children's Hospital
Birmingham, England, B4 6NH
Bristol Royal Hospital for Children
Bristol, England, BS2 8BJ
Addenbrooke's NHS Trust
Cambridge, England, CB2 2QQ
Royal Hospital for Sick Children
Edinburgh, Scotland
Royal Hospital for Sick Children
Glasgow, Scotland, G3 8SJ
St. James's Hospital
Leeds, England, LS9 7TF
Leicester Royal Infirmary
Leicester, England, LE1 5WW
Royal Liverpool Children's Hospital, Alder Hey
Liverpool, England, L12 2AP
Saint Bartholomew's Hospital
London, England, EC1A 7BE
Hospital for Sick Children NHS Trust
London, England, WC1N 3JH
Middlesex Hospital- Meyerstein Institute
London, England, WIT 3AA
Manchester Children's Hospitals (NHS Trust)
Manchester, England, M27 1HA
Newcastle Upon Tyne Hospitals NHS Trust
Newcastle upon Tyne, England, NE7 7DN
Queen's Medical Centre
Nottingham, England, NG7 2UH
Oxford Radcliffe Hospital
Oxford, England, 0X3 9DU
Llandough Hospital
Penarth, Wales, CF64 2XX
Children's Hospital - Sheffield
Sheffield, England, S10 2TH
Southampton General Hospital
Southampton, England, SO16 6YD
Royal Marsden Hospital
Sutton, England, SM2 5PT
About this study
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.
Read the 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.
- Conditions
- Brain and Central Nervous System Tumors
- Being tested
- tamoxifen citrate, radiation therapy
- Keywords
- untreated childhood brain stem glioma
- Medical subject headings
- Central Nervous System Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tamoxifen citrateDrug
radiation therapyRadiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startAug 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain and Central Nervous System TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Children's Cancer and Leukaemia Group
- Sponsor type
- University, hospital or other
- Investigators
- Anthony Michalski, MD, Study chair, Great Ormond Street Hospital for Children NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00024336
- Sponsor's protocol ID
- CCLG-CNS-1999-06
- Other IDs
- CDR0000068920, EU-20123
- Status last verified
- Dec 2006
- First submitted
- 13 Sep 2001
- Last updated
- 7 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Children With Newly Diagnosed Diffuse Pontine Gliomas Using Conventional Radiotherapy and High Dose Tamoxifen
- ClinicalTrials.gov ID
- NCT00024336
- Acronym / sponsor ID
- CCLG-CNS-1999-06
- Conditions
- Brain and Central Nervous System Tumors
- Keywords
- untreated childhood brain stem glioma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Children's Cancer and Leukaemia GroupUniversity, hospital or other
- Study start
- Aug 1999
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- Up to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tamoxifen citrate | Drug | – |
| radiation therapy | Radiation | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony Michalski, MD study chair
Great Ormond Street Hospital for Children NHS Foundation Trust
22 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing tamoxifen citrate and radiation therapy in people with Brain and Central Nervous System Tumors, run by Children's Cancer and Leukaemia Group at 22 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United Kingdom, Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2013.