Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Etoposide in Treating Young Patients With Relapsed Ependymoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Active	21 and under	Other	CCLG-CNS-2001-4 EU-20576, NCT00278252

Objectives

Primary

1. Determine the response rate in young patients with relapsing and/or refractory ependymoma treated with a rapid schedule of intravenous etoposide.

Secondary

1. Determine the possibility of second surgery or additional radiotherapy in these patients.

Entry 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

Prior/Concurrent Therapy:

• See Disease Characteristics
• No radiotherapy within the past 6 weeks
• No chemotherapy within the past 4 weeks
• Prior IV etoposide allowed

Patient Characteristics:

• Lansky performance status 30-100%
• Life expectancy ≥ 8 weeks
• Absolute neutrophil count > 1,000/mm³
• Platelet count > 100,000/mm³
• 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

Expected Enrollment

At least 14 patients will be accrued for this study.

Outcomes

Response rate by MRI after course 3

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

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.

Trial Contact Information

Trial Lead Organizations

Children's Cancer and Leukaemia Group

Linda S. Lashford, Protocol co-chair		Ph: 44-845-226-3000
Susan Picton, MD, Protocol chair		Ph: 44-11-32-064-985

United Kingdom
England
	Leeds
	Leeds Cancer Centre at St. James's University Hospital
		Susan Picton, MD	Ph:  44-11-32-064-985

Registry Information
Official Title		Phase II Study of Intravenous Etoposide in Patients with Relapsed Ependymoma
Trial Start Date		2001-07-01
Trial Completion Date		2010-07-01 (estimated)
Registered in ClinicalTrials.gov		NCT00278252
Date Submitted to PDQ		2005-09-15
Information Last Verified		2009-06-14

Back to Top