Etoposide in Treating Young Patients With Relapsed Ependymoma

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase II Study of Intravenous Etoposide in Patients With Relapsed Ependymoma

Conditions
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Brain and Central Nervous System Tumors

Intervention / Treatment
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* Drug: etoposide
* Procedure: conventional surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: etoposide|nan|
|Procedure: conventional surgery|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate by MRI after course 3 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Second surgery or additional radiotherapy in responding patients as assessed by MRI scan after course 3 or 6 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent childhood ependymoma, childhood infratentorial ependymoma, childhood supratentorial ependymoma