Brain and Central Nervous System TumorsPhase 2NCT00278252
Etoposide in Treating Young Patients With Relapsed Ependymoma
A Phase 2 study testing etoposide and conventional surgery in people with Brain and Central Nervous System Tumors, run by Children's Cancer and Leukaemia Group at 1 site in United Kingdom.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as etoposide, 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 etoposide works in treating young patients with ependymoma. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Brain and Central Nervous System Tumors
- What is being tested?
- etoposide and conventional surgery
- Type of treatment
- Surgery or procedure
- How many people
- 14 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2001to Jul 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 21 years
- All sexes
- No healthy volunteers
- Child, Adult
DISEASE CHARACTERISTICS:
- Histologically confirmed intracranial ependymoma at first, second, or third relapse
- Anaplastic (malignant) or low-grade ependymoma (cellular, papillary, clear cell, or mixed variants)
- Unequivocal evidence of tumor recurrence or progression by MRI scan after failing conventional treatment (e.g., primary surgery and adjuvant radiotherapy) for initial or recurrent disease
- Unresectable disease OR not amenable to complete surgical resection
- Measurable enhancing or non-enhancing disease on baseline scan performed within the past 2 weeks
- Patients who have undergone prior surgery must have residual measurable disease
PATIENT CHARACTERISTICS:
- Lansky performance status 30-100%
- Life expectancy ≥ 8 weeks
- Absolute neutrophil count > 1,000/mm^3
- Platelet count > 100,000/mm^3
- Serum total bilirubin normal
- AST < 2 times upper limit of normal
- No unrelated medical condition (e.g., renal or liver impairment) that would preclude chemotherapy treatment
- No active infection
- No known HIV positivity
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No radiotherapy within the past 6 weeks
- No chemotherapy within the past 4 weeks
- Prior IV etoposide allowed
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, LS9 7TF
Susan V. Picton, MD, 44-11-32-064-985
About this study
Official title: Phase II Study of Intravenous Etoposide in Patients With Relapsed Ependymoma
RATIONALE: Drugs used in chemotherapy, such as etoposide, 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 etoposide works in treating young patients with ependymoma.
Read the detailed description
OBJECTIVES:
Primary
- Determine the response rate in young patients with relapsing and/or refractory ependymoma treated with a rapid schedule of intravenous etoposide.
Secondary
- Determine the possibility of second surgery or additional radiotherapy in these patients.
OUTLINE: This is a multicenter study.
Patients receive etoposide IV over 1 hour on days 1-3, 8-10, and 15-17. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients whose tumor becomes resectable after courses 3 or 6 undergo surgical resection.
After completion of study treatment, patients are followed periodically for approximately 5 years.
PROJECTED ACCRUAL: At least 14 patients will be accrued for this study.
- Conditions
- Brain and Central Nervous System Tumors
- Being tested
- etoposide, conventional surgery
- Keywords
- recurrent childhood ependymoma, childhood infratentorial ependymoma, childhood supratentorial ependymoma
- Medical subject headings
- Central Nervous System Neoplasms, Familial ependymoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
etoposideDrug
conventional surgeryProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate by MRI after course 3
Secondary outcomes (1)
Second surgery or additional radiotherapy in responding patients as assessed by MRI scan after course 3 or 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2006 (estimated)
- Study startJul 2001
- Primary completionJul 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Cancer and Leukaemia Group
- Sponsor type
- University, hospital or other
- Investigators
- Linda S. Lashford, The Christie NHS Foundation TrustSusan V. Picton, MD, Study chair, Leeds Cancer Centre at St. James's University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00278252
- Sponsor's protocol ID
- CCLG-CNS-2001-4
- Other IDs
- CDR0000454543, EU-20576
- Status last verified
- Jun 2009
- First submitted
- 16 Jan 2006
- Last updated
- 7 Aug 2013
- Results posted
- No
Publications
Apps JR, Maycock S, Ellison DW, Jaspan T, Ritzmann TA, Macarthur D, Mallucci C, Wheatley K, Veal GJ, Grundy RG, Picton S. Phase II study of intravenous etoposide in patients with relapsed ependymoma (CNS 2001 04). Neurooncol Adv. 2022 Apr 13;4(1):vdac053. doi: 10.1093/noajnl/vdac053. eCollection 2022 Jan-Dec.
PubMed 35591977
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
- Phase II Study of Intravenous Etoposide in Patients With Relapsed Ependymoma
- ClinicalTrials.gov ID
- NCT00278252
- Acronym / sponsor ID
- CCLG-CNS-2001-4
- Conditions
- Brain and Central Nervous System Tumors
- Keywords
- recurrent childhood ependymoma, childhood infratentorial ependymoma, childhood supratentorial ependymoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Children's Cancer and Leukaemia GroupUniversity, hospital or other
- Study start
- Jul 2001
- Primary completion
- Jul 2010 (estimated)
- First posted
- 18 Jan 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 etoposide, 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 etoposide works in treating young patients with ependymoma.
Detailed description
OBJECTIVES:
Primary
- Determine the response rate in young patients with relapsing and/or refractory ependymoma treated with a rapid schedule of intravenous etoposide.
Secondary
- Determine the possibility of second surgery or additional radiotherapy in these patients.
OUTLINE: This is a multicenter study.
Patients receive etoposide IV over 1 hour on days 1-3, 8-10, and 15-17. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients whose tumor becomes resectable after courses 3 or 6 undergo surgical resection.
After completion of study treatment, patients are followed periodically for approximately 5 years.
PROJECTED ACCRUAL: At least 14 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 21 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 |
|---|---|---|
| etoposide | Drug | – |
| conventional surgery | Procedure or surgery | – |
Primary outcome
Response rate by MRI after course 3
1 secondary outcome
Second surgery or additional radiotherapy in responding patients as assessed by MRI scan after course 3 or 6
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.
- Derived from this study: PubMed 35591977Apps JR, Maycock S, Ellison DW, Jaspan T, Ritzmann TA, Macarthur D, Mallucci C, Wheatley K, Veal GJ, Grundy RG, Picton S. Phase II study of intravenous etoposide in patients with relapsed ependymoma (CNS 2001 04). Neurooncol Adv. 2022 Apr 13;4(1):vdac053. doi: 10.1093/noajnl/vdac053. eCollection 2022 Jan-Dec.
Related trials for Brain and Central Nervous System Tumors
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingPhase 1/2
PLX038 in Primary Central Nervous System Tumors Containing MYC or MYCN Amplifications
Glioma, Medulloblastoma
Recruiting
Virtual Home-based Exercise Intervention (RISE) to Improve Cancer-Related Cognitive Impairment and Gut Microbiome in Adolescent and Young Adult Brain Tumor Survivors
Cancer-related Cognitive Dysfunction, Primary Brain Neoplasm
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.
Linda S. Lashford
The Christie NHS Foundation Trust
Susan V. Picton, MD study chair
Leeds Cancer Centre at St. James's University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing etoposide and conventional surgery in people with Brain and Central Nervous System Tumors, run by Children's Cancer and Leukaemia Group at 1 site 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: 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 1 site 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.
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?
Response rate by MRI after course 3. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00278252, which also lists 1 linked publication.
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.