Etoposide in Treating Young Patients With Relapsed Ependymoma

Phase 2

• Conditions: Brain and Central Nervous System Tumors

• Registration Number: NCT00278252
• Lead Sponsor: Children's Cancer and Leukaemia Group

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.

Study Timeline

• Study Start: 2001-07
• Study First Submitted: 2006-01-16
• Study First Submitted QC: 2006-01-16
• Study First Posted: 2006-01-18
• Status Verified: 2009-06
• Primary Completion: 2010-07
• Last Update Submitted: 2013-08-06
• Last Update Posted: 2013-08-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response rate by MRI after course 3

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Leeds Cancer Centre at St. James's University Hospital; 🇬🇧 Leeds, England, United Kingdom