Brain and Central Nervous System TumorsPhase 2NCT00514397
Temozolomide and Radiation Therapy in Treating Young Patients With Pontine Glioma
A Phase 2 study testing motexafin gadolinium, temozolomide and adjuvant therapy in people with Brain and Central Nervous System Tumors, run by Children's Cancer and Leukaemia Group at 21 sites in 2 countries.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Read more about this study
- Who is it for?
- Ages 2 to 21 years
- Conditions the study is for
- Brain and Central Nervous System Tumors
- What is being tested?
- motexafin gadolinium, temozolomide and adjuvant therapy
- Type of treatment
- Surgery or procedure
- How many people
- 43 participants
- Where
- 21 sitesin 2 countries
- Study dates
- Jan 2008to 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 2 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Newly diagnosed diffuse intrinsic lesion centered in the pons on MRI
- No requirement for histological diagnosis
- Clinical history < 6 months
- Clinical findings must include at least 1 of the 3 following signs of brainstem tumor:
- Cranial nerve deficit
- Long tract signs
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- Ataxia
- Karnofsky performance status (PS) or Lansky PS 60-100% (unless reason for decrease in status is a direct result of neurological involvement of the brainstem glioma)
- Life expectancy > 12 weeks
- Absolute neutrophil count ≥ 1,000/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 10 g/dL
- Urea and serum creatinine < 1.5 times upper limit of normal (ULN)
- Total and direct bilirubin < 1.5 times ULN
- AST and ALT < 3 times ULN
- Negative pregnancy test within 7 days prior to administration of temozolomide for women of childbearing potential
Who cannot join
- Focal lesions of brainstem
- Predominantly exophytic tumors
- PATIENT CHARACTERISTICS:
- Frequent vomiting and/or medical condition, that could interfere with oral medication intake (e.g., partial bowel obstruction)
- Pregnant or breast-feeding women
- PRIOR CONCURRENT THERAPY:
Show all 9Show fewer
- Prior chemotherapy or radiotherapy
- Other concurrent investigational drugs
- Other concurrent chemotherapy, immunotherapy, or biologic therapy
Trial locations and contacts
21 sites in 2 countries.
21 sites in 2 countries
United Kingdom20 sites, 20 recruiting
- Recruiting
Royal Aberdeen Children's Hospital
Aberdeen, Scotland, AB25 2ZG
Veronica Neefjes, 44-1224-550-217
- Recruiting
Royal Belfast Hospital for Sick Children
Belfast, Northern Ireland, BT12 6BE
Anthony McCarthy, MD, 44-289-063-3631, anthonymcarthy@royalhospital.n.i.nhs.uk
- Recruiting
Birmingham Children's Hospital
Birmingham, England, B4 6NH
Martin W. English, MD, 44-121-333-8412, martin.english@bch.nhs.uk
- Recruiting
Bristol Royal Hospital for Children
Bristol, England, BS2 8AE
Contact Person, 44-117-342-0205
- Recruiting
Addenbrooke's Hospital
Cambridge, England, CB2 2QQ
Amos Burke, MD, 44-1223-348-151
- Recruiting
Childrens Hospital for Wales
Cardiff, Wales, CF14 4XW
Heidi Traunecker, MD, PhD, 44-29-2074-2285, heidi.traunecker@cardiffandvale.wales.nhs.uk
- Recruiting
Royal Hospital for Sick Children
Edinburgh, Scotland, EH9 1LF
W. Hamish Wallace, MD, 44-131-536-0426
- Recruiting
Royal Hospital for Sick Children
Glasgow, Scotland, G3 8SJ
Milind D. Ronghe, MD, 44-141-201-9309
- Recruiting
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, LS9 7TF
Adam Glaser, MD, 44-113-206-4984, adam.glaser@leedsth.nhs.uk
- Recruiting
Leicester Royal Infirmary
Leicester, England, LE1 5WW
Johann Visser, MD, 44-116-258-5309, johannes.visser@uhl-tr.nhs.uk
- Recruiting
Royal Liverpool Children's Hospital, Alder Hey
Liverpool, England, L12 2AP
Contact Person, 44-151-252-5294
- Recruiting
University College Hospital
London, England, NW1 2BU
Contact Person, 44-20-7380-9950
- Recruiting
Great Ormond Street Hospital for Children
London, England, WC1N 3JH
Contact Person, 44-20-7829-7924
- Recruiting
Royal Manchester Children's Hospital
Manchester, England, M27 4HA
Bernadette Brennan, MD, 44-161-922-2227, bernadette.brennan@cmmc.nhs.uk
- Recruiting
Sir James Spence Institute of Child Health at Royal Victoria Infirmary
Newcastle upon Tyne, England, NE1 4LP
Contact Person, 44-113-206-4985
- Recruiting
Queen's Medical Centre
Nottingham, England, NG7 2UH
Contact Person, 44-115-823-0620
- Recruiting
Oxford Radcliffe Hospital
Oxford, England, 0X3 9DU
Contact Person, 44-1865-234-205
- Recruiting
Children's Hospital - Sheffield
Sheffield, England, S10 2TH
Contact Person, 44-114-271-7366
- Recruiting
Southampton General Hospital
Southampton, England, SO16 6YD
Contact Person, 44-2380-794-101
- Recruiting
Royal Marsden - Surrey
Sutton, England, SM2 5PT
Contact Person, 44-20-8661-3455
Ireland1 site, 1 recruiting
- Recruiting
Our Lady's Hospital for Sick Children Crumlin
Dublin, 12
Contact Person, 44-353-1-409-6659
About this study
Official title: A Phase II Multi-Centre Study of Concomitant and Prolonged Adjuvant Temozolomide With Radiotherapy in Diffuse Pontine Gliomas
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving temozolomide together with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving temozolomide together with radiation therapy works in treating young patients with pontine glioma.
Read the detailed description
OBJECTIVES:
Primary
- To evaluate the time to death in patients with newly diagnosed diffuse pontine gliomas, when treated with the combination of concomitant low-dose oral temozolomide and radiotherapy, followed by up to 12 months of maintenance therapy with extended low-dose temozolomide.
- To assess the quality of life of patients with diffuse pontine gliomas during and after treatment.
Secondary
- To evaluate the time to tumor progression in patients with newly diagnosed diffuse pontine gliomas, when treated with the combination of concomitant low-dose oral temozolomide and radiotherapy, followed by up to 12 months of maintenance therapy with extended low-dose temozolomide.
- To evaluate and document toxicities from the administration of temozolomide combined with radiotherapy and to further study any toxicities associated with the chronic administration of the extended low-dose temozolomide schedule in this population group.
- To document radiological response to the above treatment with MR imaging and, where available, functional imaging.
OUTLINE: This is a multicenter study.
- Chemoradiotherapy: Patients receive oral temozolomide once daily for 6 weeks (7 days per week) with concurrent radiotherapy (5 days per week).
Patients without evidence of disease progression proceed to maintenance therapy beginning at least 4 weeks after completion of radiotherapy.
- Maintenance therapy: Patients receive oral temozolomide daily on days 1-21. Treatment repeats every 4 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed prior to chemoradiotherapy and prior to course 1 of adjuvant temozolomide and prior to every 3 subsequent courses of adjuvant temozolomide.
After completion of study therapy, patients are followed every 8 weeks.
- Conditions
- Brain and Central Nervous System Tumors
- Being tested
- motexafin gadolinium, temozolomide, adjuvant therapy, quality-of-life assessment, 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.
motexafin gadoliniumDrug
temozolomideDrug
adjuvant therapyProcedure or surgery
quality-of-life assessmentProcedure or surgery
radiation therapyRadiation
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Quality of life including health status, behavior, and the subjective experience using HUI and SDQ methods
Secondary outcomes (2)
Toxicity, steroid usage, and radiological response
Adverse events, including abnormal laboratory parameters, as assessed by CTC criteria
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2007 (estimated)
- Study startJan 2008
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
- Allocation
- Non-randomised
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Cancer and Leukaemia Group
- Sponsor type
- University, hospital or other
- Investigators
- Simon Bailey, MD, Principal investigator, Sir James Spence Institute of Child Health at Royal Victoria Infirmary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00514397
- Sponsor's protocol ID
- CCLG-CNS-2007-04
- Other IDs
- CDR0000560114, EU-20746, EUDRACT-2007-001768-60
- Status last verified
- Jun 2009
- First submitted
- 8 Aug 2007
- Last updated
- 12 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Multi-Centre Study of Concomitant and Prolonged Adjuvant Temozolomide With Radiotherapy in Diffuse Pontine Gliomas
- ClinicalTrials.gov ID
- NCT00514397
- Acronym / sponsor ID
- CCLG-CNS-2007-04
- Conditions
- Brain and Central Nervous System Tumors
- Keywords
- untreated childhood brain stem glioma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Children's Cancer and Leukaemia GroupUniversity, hospital or other
- Study start
- Jan 2008
- First posted
- 9 Aug 2007 (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: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving temozolomide together with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving temozolomide together with radiation therapy works in treating young patients with pontine glioma.
Detailed description
OBJECTIVES:
Primary
- To evaluate the time to death in patients with newly diagnosed diffuse pontine gliomas, when treated with the combination of concomitant low-dose oral temozolomide and radiotherapy, followed by up to 12 months of maintenance therapy with extended low-dose temozolomide.
- To assess the quality of life of patients with diffuse pontine gliomas during and after treatment.
Secondary
- To evaluate the time to tumor progression in patients with newly diagnosed diffuse pontine gliomas, when treated with the combination of concomitant low-dose oral temozolomide and radiotherapy, followed by up to 12 months of maintenance therapy with extended low-dose temozolomide.
- To evaluate and document toxicities from the administration of temozolomide combined with radiotherapy and to further study any toxicities associated with the chronic administration of the extended low-dose temozolomide schedule in this population group.
- To document radiological response to the above treatment with MR imaging and, where available, functional imaging.
OUTLINE: This is a multicenter study.
- Chemoradiotherapy: Patients receive oral temozolomide once daily for 6 weeks (7 days per week) with concurrent radiotherapy (5 days per week).
Patients without evidence of disease progression proceed to maintenance therapy beginning at least 4 weeks after completion of radiotherapy.
- Maintenance therapy: Patients receive oral temozolomide daily on days 1-21. Treatment repeats every 4 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed prior to chemoradiotherapy and prior to course 1 of adjuvant temozolomide and prior to every 3 subsequent courses of adjuvant temozolomide.
After completion of study therapy, patients are followed every 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
Who may qualify
- Ages
- 2 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (16 listed)
- Newly diagnosed diffuse intrinsic lesion centered in the pons on MRI
- Clinical findings must include at least 1 of the 3 following signs of brainstem tumor:
- Karnofsky performance status (PS) or Lansky PS 60-100% (unless reason for decrease in status is a direct result of neurological involvement of the brainstem glioma)
- Life expectancy > 12 weeks
- Absolute neutrophil count ≥ 1,000/mm³
Key exclusion criteria (9 listed)
- Focal lesions of brainstem
- Predominantly exophytic tumors
- Frequent vomiting and/or medical condition, that could interfere with oral medication intake (e.g., partial bowel obstruction)
- Pregnant or breast-feeding women
- Prior chemotherapy or radiotherapy
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 |
|---|---|---|
| motexafin gadolinium | Drug | – |
| temozolomide | Drug | – |
| adjuvant therapy | Procedure or surgery | – |
| quality-of-life assessment | Procedure or surgery | – |
| radiation therapy | Radiation | – |
Primary outcome
Overall survival
Quality of life including health status, behavior, and the subjective experience using HUI and SDQ methods
2 secondary outcomes
Toxicity, steroid usage, and radiological response
Adverse events, including abnormal laboratory parameters, as assessed by CTC criteria
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 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.
Simon Bailey, MD principal investigator
Sir James Spence Institute of Child Health at Royal Victoria Infirmary
21 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 motexafin gadolinium, temozolomide and adjuvant therapy in people with Brain and Central Nervous System Tumors, run by Children's Cancer and Leukaemia Group at 21 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?
The sponsor lists 16 inclusion and 9 exclusion criteria. 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 12 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 21 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 12 Aug 2013.