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Etoposide in Treating Young Patients With Relapsed Ependymoma

Primary Purpose

Brain and Central Nervous System Tumors

Status
Unknown status
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
etoposide
conventional surgery
Sponsored by
Children's Cancer and Leukaemia Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring recurrent childhood ependymoma, childhood infratentorial ependymoma, childhood supratentorial ependymoma

Eligibility Criteria

undefined - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Leeds Cancer Centre at St. James's University HospitalRecruiting

Outcomes

Primary Outcome Measures

Response rate by MRI after course 3

Secondary Outcome Measures

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

Full Information

First Posted
January 16, 2006
Last Updated
August 6, 2013
Sponsor
Children's Cancer and Leukaemia Group
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1. Study Identification

Unique Protocol Identification Number
NCT00278252
Brief Title
Etoposide in Treating Young Patients With Relapsed Ependymoma
Official Title
Phase II Study of Intravenous Etoposide in Patients With Relapsed Ependymoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Unknown status
Study Start Date
July 2001 (undefined)
Primary Completion Date
July 2010 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Children's Cancer and Leukaemia Group

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors
Keywords
recurrent childhood ependymoma, childhood infratentorial ependymoma, childhood supratentorial ependymoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
14 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
etoposide
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Primary Outcome Measure Information:
Title
Response rate by MRI after course 3
Secondary Outcome Measure Information:
Title
Second surgery or additional radiotherapy in responding patients as assessed by MRI scan after course 3 or 6

10. Eligibility

Sex
All
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linda S. Lashford
Organizational Affiliation
The Christie NHS Foundation Trust
First Name & Middle Initial & Last Name & Degree
Susan V. Picton, MD
Organizational Affiliation
Leeds Cancer Centre at St. James's University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Leeds Cancer Centre at St. James's University Hospital
City
Leeds
State/Province
England
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan V. Picton, MD
Phone
44-11-32-064-985

12. IPD Sharing Statement

Citations:
PubMed Identifier
35591977
Citation
Apps JR, Maycock S, Ellison DW, Jaspan T, Ritzmann TA, Macarthur D, Mallucci C, Wheatley K, Veal GJ, Grundy RG, Picton S. Phase II study of intravenous etoposide in patients with relapsed ependymoma (CNS 2001 04). Neurooncol Adv. 2022 Apr 13;4(1):vdac053. doi: 10.1093/noajnl/vdac053. eCollection 2022 Jan-Dec.
Results Reference
derived

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Etoposide in Treating Young Patients With Relapsed Ependymoma

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