Etoposide in Treating Young Patients With Relapsed Ependymoma
Recruitment status was: Recruiting
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.
Brain and Central Nervous System Tumors
Procedure: conventional surgery
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Intravenous Etoposide in Patients With Relapsed Ependymoma|
- Response rate by MRI after course 3 [ Designated as safety issue: No ]
- Second surgery or additional radiotherapy in responding patients as assessed by MRI scan after course 3 or 6 [ Designated as safety issue: No ]
|Study Start Date:||July 2001|
|Estimated Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
- Determine the response rate in young patients with relapsing and/or refractory ependymoma treated with a rapid schedule of intravenous etoposide.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00278252
|Leeds Cancer Centre at St. James's University Hospital|
|Leeds, England, United Kingdom, LS9 7TF|
|OverallOfficial:||Linda S. Lashford||The Christie NHS Foundation Trust|
|Study Chair:||Susan V. Picton, MD||Leeds Cancer Centre at St. James's University Hospital|