Etoposide in Treating Young Patients With Relapsed Ependymoma
NCT ID: NCT00278252
Last Updated: 2013-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
14 participants
INTERVENTIONAL
2001-07-31
Brief Summary
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PURPOSE: This phase II trial is studying how well etoposide works in treating young patients with ependymoma.
Detailed Description
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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
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Keywords
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Study Design
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TREATMENT
NONE
Interventions
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etoposide
conventional surgery
Eligibility Criteria
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Inclusion Criteria
* 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
21 Years
ALL
No
Sponsors
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Children's Cancer and Leukaemia Group
OTHER
Principal Investigators
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Linda S. Lashford
Role:
The Christie NHS Foundation Trust
Susan V. Picton, MD
Role: STUDY_CHAIR
Leeds Cancer Centre at St. James's University Hospital
Locations
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Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom
Countries
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Facility Contacts
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Susan V. Picton, MD
Role: primary
References
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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.
Other Identifiers
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CDR0000454543
Identifier Type: REGISTRY
Identifier Source: secondary_id
EU-20576
Identifier Type: -
Identifier Source: secondary_id
CCLG-CNS-2001-4
Identifier Type: -
Identifier Source: org_study_id