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Etoposide in Treating Young Patients With Relapsed Ependymoma

Phase II Study of Intravenous Etoposide in Patients With Relapsed Ependymoma

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00278252
Enrollment
14
Registered
2006-01-18
Start date
2001-07-31
Completion date
Unknown
Last updated
2013-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain and Central Nervous System Tumors

Keywords

recurrent childhood ependymoma, childhood infratentorial ependymoma, childhood supratentorial ependymoma

Brief 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.

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.

Interventions

DRUGetoposide
PROCEDUREconventional surgery

Sponsors

Children's Cancer and Leukaemia Group
Lead SponsorOTHER

Study design

Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 21 Years
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Response rate by MRI after course 3

Secondary

MeasureTime frame
Second surgery or additional radiotherapy in responding patients as assessed by MRI scan after course 3 or 6

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026