Brain and Central Nervous System TumorsNCT00683319
Observing Young Patients With Ependymoma Undergoing Standard Combination Chemotherapy
An observational study of Brain and Central Nervous System Tumors and Cognitive/Functional Effects, run by Children's Cancer and Leukaemia Group at 10 sites in United Kingdom.
Trial summary
RATIONALE: Gathering information about how young patients with ependymoma respond to standard combination chemotherapy and learning about the long-term effects of this treatment may help doctors plan better treatment. 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, Cognitive/Functional Effects, Long-term Effects Secondary to Cancer Therapy in Children
- What is being tested?
- carboplatin, cisplatin and cyclophosphamide
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 10 sitesUnited Kingdom
- Study dates
- Apr 2008to Mar 2034
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 WHO grade 3 anaplastic (malignant) ependymoma or WHO grade 2 ependymoma, including the following variants:
- Papillary
- Cellular
- Clear cell
- Tanycytic
- No myxopapillary ependymoma, subependymoma, or ependymoblastoma
- Meets 1 of the following criteria:
- Has undergone complete resection of the primary tumor (prior to starting chemotherapy)
- Two or more surgical procedures to achieve complete resection allowed
- Metastatic disease at diagnosis (with or without complete resection of the primary tumor)
- Unable to undergo complete resection of the primary tumor (with or without metastatic disease)
- Patients with measurable residual disease (primary or metastatic disease) are eligible provided they undergo treatment on clinical trial CCLG-CNS-2005-03 prior to entering this study
- Has undergone surgical resection OR completed treatment on clinical trial CCLG-CNS-2005-03 within the past 3 weeks
- Patients who are unable to tolerate chemotherapy or who do not receive treatment according to the CCLG guidelines for ependymoma due to parental preference or recommendation from the treating physician are eligible
PATIENT CHARACTERISTICS:
- Able to tolerate IV hydration
- No active infection
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United Kingdom10 sites
Aberdeen Royal Infirmary
Aberdeen, Scotland, AB25 2ZN
Birmingham Children's Hospital
Birmingham, England, B4 6NH
Addenbrooke's Hospital
Cambridge, England, CB2 2QQ
Royal Hospital for Sick Children
Glasgow, Scotland, G3 8SJ
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, LS9 7TF
Royal Liverpool Children's Hospital, Alder Hey
Liverpool, England, L12 2AP
Great Ormond Street Hospital for Children
London, England, WC1N 3JH
Royal Manchester Children's Hospital
Manchester, England, M27 4HA
Queen's Medical Centre
Nottingham, England, NG7 2UH
Children's Hospital - Sheffield
Sheffield, England, S10 2TH
About this study
Official title: CCLG Observational Study of the Outcome of Ependymoma in Infants Diagnosed Before Their Third Birthday
RATIONALE: Gathering information about how young patients with ependymoma respond to standard combination chemotherapy and learning about the long-term effects of this treatment may help doctors plan better treatment.
PURPOSE: This phase III trial is observing young patients with ependymoma undergoing standard combination chemotherapy.
Read the detailed description
OBJECTIVES:
Primary
- To determine the overall survival and event-free survival of all infants diagnosed with ependymoma before their third birthday.
- To determine the overall survival and event-free survival of infants diagnosed with ependymoma before their third birthday when treated with standard chemotherapy comprising vincristine, carboplatin, high-dose methotrexate, cyclophosphamide, and cisplatin.
Secondary
- To investigate the reasons why the primary tumor was completely resected in patients who were able to undergo complete resection of the tumor.
- To continue to investigate the biological characteristics of ependymoma.
- To correlate functional imaging studies of ependymoma with biological characteristics of the tumor.
- To provide a standard treatment regimen for patients with residual disease after optimal surgery who have already participated in a phase II study.
- To prospectively document renal function, hearing, and neurocognitive late effects after completion of study treatment.
OUTLINE: This is a multicenter study. Patients are stratified according to extent of prior surgical resection and presence of metastatic disease (complete resection of tumor vs metastatic disease at diagnosis vs no complete resection of tumor).
Patients receive vincristine IV on days 1, 15, and 29, carboplatin IV over 1 hour on day 1, high-dose methotrexate* IV over 24 hours on day 15, cyclophosphamide IV over 1 hour on day 29, and cisplatin IV over 48 hours on days 43 and 44. Treatment repeats every 8 weeks for 7 courses in the absence of disease progression or unacceptable toxicity. Patients with residual disease after completion of treatment may receive other treatment at the discretion of the investigator.
NOTE: *Patients initially treated on clinical trial CCLG-CNS-2005-03 who have no residual disease do not receive high-dose methotrexate in courses 5-7.
Patients undergo observational assessments comprising physical and neurological examination; MRI/ MRS scanning of the head and spine; and audiology, renal, endocrine, neurocognitive, and quality of life evaluations periodically for at least 5 years after the completion of study treatment.
- Conditions
- Brain and Central Nervous System Tumors, Cognitive/Functional Effects, Long-term Effects Secondary to Cancer Therapy in Children, Ototoxicity
- Being tested
- carboplatin, cisplatin, cyclophosphamide, methotrexate, vincristine sulfate
- Keywords
- long-term effects secondary to cancer therapy in children, cognitive/functional effects, ototoxicity, childhood infratentorial ependymoma, childhood supratentorial ependymoma
- Medical subject headings
- Central Nervous System Neoplasms, Ototoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carboplatinDrug
cisplatinDrug
cyclophosphamideDrug
methotrexateDrug
adjuvant therapyProcedure or surgery
cognitive assessmentProcedure or surgery
magnetic resonance imagingProcedure or surgery
magnetic resonance spectroscopic imagingProcedure or surgery
quality-of-life assessmentProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Event-free survival
Response to chemotherapy, if there is residual disease
Requirement for radiotherapy (i.e., residual disease at the completion of chemotherapy, progressive disease during chemotherapy, or recurrent disease during or after completion chemotherapy)
Late effects of treatment (i.e., ototoxicity and nephrotoxicity at the completion of chemotherapy and neurocognitive outcomes at 5, 7, 11, and 16 years of age)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2008 (estimated)
- Study startApr 2008
- Primary completionMar 2034 (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
- Observational
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Cancer and Leukaemia Group
- Sponsor type
- University, hospital or other
- Investigators
- Martin W. English, MD, Principal investigator, Birmingham Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00683319
- Sponsor's protocol ID
- CDR0000590666
- Other IDs
- CCLG-CNS-2007-09, EU-20835
- Status last verified
- Jun 2009
- First submitted
- 21 May 2008
- Last updated
- 20 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CCLG Observational Study of the Outcome of Ependymoma in Infants Diagnosed Before Their Third Birthday
- ClinicalTrials.gov ID
- NCT00683319
- Acronym / sponsor ID
- CDR0000590666
- Conditions
- Brain and Central Nervous System Tumors, Cognitive/Functional Effects, Long-term Effects Secondary to Cancer Therapy in Children, Ototoxicity
- Keywords
- long-term effects secondary to cancer therapy in children, cognitive/functional effects, ototoxicity, childhood infratentorial ependymoma, childhood supratentorial ependymoma
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Children's Cancer and Leukaemia GroupUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Mar 2034 (estimated)
- First posted
- 23 May 2008 (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: Gathering information about how young patients with ependymoma respond to standard combination chemotherapy and learning about the long-term effects of this treatment may help doctors plan better treatment.
PURPOSE: This phase III trial is observing young patients with ependymoma undergoing standard combination chemotherapy.
Detailed description
OBJECTIVES:
Primary
- To determine the overall survival and event-free survival of all infants diagnosed with ependymoma before their third birthday.
- To determine the overall survival and event-free survival of infants diagnosed with ependymoma before their third birthday when treated with standard chemotherapy comprising vincristine, carboplatin, high-dose methotrexate, cyclophosphamide, and cisplatin.
Secondary
- To investigate the reasons why the primary tumor was completely resected in patients who were able to undergo complete resection of the tumor.
- To continue to investigate the biological characteristics of ependymoma.
- To correlate functional imaging studies of ependymoma with biological characteristics of the tumor.
- To provide a standard treatment regimen for patients with residual disease after optimal surgery who have already participated in a phase II study.
- To prospectively document renal function, hearing, and neurocognitive late effects after completion of study treatment.
OUTLINE: This is a multicenter study. Patients are stratified according to extent of prior surgical resection and presence of metastatic disease (complete resection of tumor vs metastatic disease at diagnosis vs no complete resection of tumor).
Patients receive vincristine IV on days 1, 15, and 29, carboplatin IV over 1 hour on day 1, high-dose methotrexate* IV over 24 hours on day 15, cyclophosphamide IV over 1 hour on day 29, and cisplatin IV over 48 hours on days 43 and 44. Treatment repeats every 8 weeks for 7 courses in the absence of disease progression or unacceptable toxicity. Patients with residual disease after completion of treatment may receive other treatment at the discretion of the investigator.
NOTE: *Patients initially treated on clinical trial CCLG-CNS-2005-03 who have no residual disease do not receive high-dose methotrexate in courses 5-7.
Patients undergo observational assessments comprising physical and neurological examination; MRI/ MRS scanning of the head and spine; and audiology, renal, endocrine, neurocognitive, and quality of life evaluations periodically for at least 5 years after the completion of study treatment.
Study design
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 |
|---|---|---|
| carboplatin | Drug | – |
| cisplatin | Drug | – |
| cyclophosphamide | Drug | – |
| methotrexate | Drug | – |
| vincristine sulfate | Drug | – |
| adjuvant therapy | Procedure or surgery | – |
| cognitive assessment | Procedure or surgery | – |
| magnetic resonance imaging | Procedure or surgery | – |
| magnetic resonance spectroscopic imaging | Procedure or surgery | – |
| quality-of-life assessment | Procedure or surgery | – |
Primary outcome
Overall survival
Event-free survival
Response to chemotherapy, if there is residual disease
Requirement for radiotherapy (i.e., residual disease at the completion of chemotherapy, progressive disease during chemotherapy, or recurrent disease during or after completion chemotherapy)
Late effects of treatment (i.e., ototoxicity and nephrotoxicity at the completion of chemotherapy and neurocognitive outcomes at 5, 7, 11, and 16 years of age)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 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 principal investigator
Birmingham Children's Hospital
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain and Central Nervous System Tumors and Cognitive/Functional Effects, run by Children's Cancer and Leukaemia Group at 10 sites in United Kingdom.
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: under way, not looking for participants, as of the sponsor's last update on 20 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 10 sites in United Kingdom. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Overall survival. The study lists 5 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 20 Sep 2013.