Brain and Central Nervous System TumorsPhase 2NCT00287924
High-Dose Methotrexate in Treating Young Patients With Residual Ependymoma
A Phase 2 study testing methotrexate 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 methotrexate, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well high-dose methotrexate works in treating young patients with residual ependymoma. Read more about this study
- Who is it for?
- Ages Up to 2 years
- Conditions the study is for
- Brain and Central Nervous System Tumors
- What is being tested?
- methotrexate and adjuvant therapy
- Type of treatment
- Surgery or procedure
- How many people
- 29 participants
- Where
- 21 sitesin 2 countries
- Study dates
- Mar 2005to Mar 2010
- 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 2 years
- All sexes
- No healthy volunteers
- Child
DISEASE CHARACTERISTICS:
- Histologically confirmed ependymoma, including the following histologic variants:
- Cellular
- Papillary
- Clear-cell
- Tanycytic
- Anaplastic (malignant) ependymoma
- The following diagnoses are excluded:
- Myxopapillary ependymoma
- Subependymomas
- Ependymoblastomas
- Primitive neuroectodermal tumors (PNETs)
- Other neuroepithelial tumors
- Choroid plexus tumors
- Germ cell tumors
- Residual measurable ependymoma after maximal surgical resection, including second-look surgery, if deemed necessary
- Has undergone surgical resection within the past 3 weeks
PATIENT CHARACTERISTICS:
- At least 3 months to under 3 years of age
- Neutrophil count > 1,000/mm^3
- Platelet count > 100,000/mm^3
- Able to tolerate chemotherapy
- No co-existent unrelated disease (i.e., renal or hematological) that would preclude chemotherapy treatment
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Recovered from prior surgery
- No previous chemotherapy
- Previous steroids allowed
- No previous radiotherapy
Trial locations and contacts
21 sites in 2 countries.
21 sites in 2 countries
United Kingdom20 sites
Royal Aberdeen Children's Hospital
Aberdeen, Scotland, AB25 2ZG
Royal Belfast Hospital for Sick Children
Belfast, Northern Ireland, BT12 6BE
Birmingham Children's Hospital
Birmingham, England, B4 6NH
Institute of Child Health at University of Bristol
Bristol, England, BS2 8AE
Addenbrooke's Hospital
Cambridge, England, CB2 2QQ
Childrens Hospital for Wales
Cardiff, Wales, CF14 4XW
Royal Hospital for Sick Children
Edinburgh, Scotland, EH9 1LF
Royal Hospital for Sick Children
Glasgow, Scotland, G3 8SJ
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, LS9 7TF
Leicester Royal Infirmary
Leicester, England, LE1 5WW
Royal Liverpool Children's Hospital, Alder Hey
Liverpool, England, L12 2AP
Royal London Hospital
London, England, E1 1BB
Great Ormond Street Hospital for Children
London, England, WC1N 3JH
Royal Manchester Children's Hospital
Manchester, England, M27 4HA
Sir James Spence Institute of Child Health at Royal Victoria Infirmary
Newcastle upon Tyne, England, NE1 4LP
Queen's Medical Centre
Nottingham, England, NG7 2UH
Oxford Radcliffe Hospital
Oxford, England, 0X3 9DU
Children's Hospital - Sheffield
Sheffield, England, S10 2TH
Southampton General Hospital
Southampton, England, SO16 6YD
Royal Marsden - Surrey
Sutton, England, SM2 5PT
About this study
Official title: Phase II Study of High-Dose Methotrexate in Children With Residual Ependymoma
RATIONALE: Drugs used in chemotherapy, such as methotrexate, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well high-dose methotrexate works in treating young patients with residual ependymoma.
Read the detailed description
OBJECTIVES:
Primary
- Determine the activity of high-dose methotrexate as upfront-window therapy in young patients with residual ependymoma.
Secondary
- Assess the reasons why primary surgery was complete/incomplete in these patients.
- Assess the feasibility and toxicity of second-look surgery after 3 courses of high-dose methotrexate in cases where initial surgery was incomplete.
OUTLINE: This is a multicenter, open-label study.
Patients receive high-dose methotrexate IV continuously over 24 hours on days 0, 14, and 28 in the absence of disease progression or unacceptable toxicity. Patients then proceed to further chemotherapy on protocol UKCCSG-CNS-9204.
After completion of study treatment, patients are followed periodically for 9 years.
PROJECTED ACCRUAL: A total of 29 patients will be accrued for this study.
- Conditions
- Brain and Central Nervous System Tumors
- Being tested
- methotrexate, adjuvant therapy
- Keywords
- childhood infratentorial ependymoma, childhood supratentorial ependymoma, newly diagnosed childhood ependymoma
- 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.
methotrexateDrug
adjuvant therapyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Activity of high-dose methotrexate at 6 weeks
Secondary outcomes (3)
Assess reasons why primary surgery is complete or incomplete at diagnosis
Feasibility and toxicity of second look surgery after course 3 at 2 months
Compare functional imaging studies of ependymomas with biological characteristics of the tumors at diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2006 (estimated)
- Study startMar 2005
- Primary completionMar 2010 (estimated)
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
- Masking
- None (open label)
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Cancer and Leukaemia Group
- Sponsor type
- University, hospital or other
- Investigators
- Martin W. English, MD, Study chair, Birmingham Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00287924
- Sponsor's protocol ID
- CDR0000454548
- Other IDs
- CCLG-CNS-2005-03, EU-20581, EUDRACT-2004-004405-14
- Status last verified
- Jun 2009
- First submitted
- 6 Feb 2006
- Last updated
- 17 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of High-Dose Methotrexate in Children With Residual Ependymoma
- ClinicalTrials.gov ID
- NCT00287924
- Acronym / sponsor ID
- CDR0000454548
- Conditions
- Brain and Central Nervous System Tumors
- Keywords
- childhood infratentorial ependymoma, childhood supratentorial ependymoma, newly diagnosed childhood ependymoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Children's Cancer and Leukaemia GroupUniversity, hospital or other
- Study start
- Mar 2005
- Primary completion
- Mar 2010 (estimated)
- First posted
- 7 Feb 2006 (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 methotrexate, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well high-dose methotrexate works in treating young patients with residual ependymoma.
Detailed description
OBJECTIVES:
Primary
- Determine the activity of high-dose methotrexate as upfront-window therapy in young patients with residual ependymoma.
Secondary
- Assess the reasons why primary surgery was complete/incomplete in these patients.
- Assess the feasibility and toxicity of second-look surgery after 3 courses of high-dose methotrexate in cases where initial surgery was incomplete.
OUTLINE: This is a multicenter, open-label study.
Patients receive high-dose methotrexate IV continuously over 24 hours on days 0, 14, and 28 in the absence of disease progression or unacceptable toxicity. Patients then proceed to further chemotherapy on protocol UKCCSG-CNS-9204.
After completion of study treatment, patients are followed periodically for 9 years.
PROJECTED ACCRUAL: A total of 29 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 |
|---|---|---|
| methotrexate | Drug | – |
| adjuvant therapy | Procedure or surgery | – |
Primary outcome
Activity of high-dose methotrexate at 6 weeks
3 secondary outcomes
Assess reasons why primary surgery is complete or incomplete at diagnosis
Feasibility and toxicity of second look surgery after course 3 at 2 months
Compare functional imaging studies of ependymomas with biological characteristics of the tumors at diagnosis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 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.
Martin W. English, MD study chair
Birmingham Children's Hospital
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 methotrexate 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?
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 17 Sep 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Activity of high-dose methotrexate at 6 weeks. 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 17 Sep 2013.