NCT00278252UnknownPhase 2
Phase II Study of Intravenous Etoposide in Patients With Relapsed Ependymoma
Children's Cancer and Leukaemia Group2 sites in 1 country14 target enrollmentStarted: July 1, 2001Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 14
- Locations
- 2
- Primary Endpoint
- Response rate by MRI after course 3
Study Overview
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.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- — to 21 Years (Child, Adult)
- Sex
- All
- Accepts 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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Response rate by MRI after course 3
Secondary Outcomes
- Second surgery or additional radiotherapy in responding patients as assessed by MRI scan after course 3 or 6
Investigators
Study Sites (2)
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