Etoposide in Treating Young Patients With Relapsed Ependymoma

Brain and Central Nervous System Tumors Clinical Trial

Official title:

Phase II Study of Intravenous Etoposide in Patients With Relapsed Ependymoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00278252
• Other study ID #: CCLG-CNS-2001-4
• Secondary ID: CDR0000454543EU-
• Status: Recruiting
• Phase: Phase 2
• First received: January 16, 2006
• Last updated: August 6, 2013
• Start date: July 2001

Study information

• Verified date: June 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 14
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 21 Years

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Ependymoma
• Nervous System Neoplasms

Intervention

Drug:
• etoposide

Procedure:
• conventional surgery

Locations

Country	Name	City	State
United Kingdom	Leeds Cancer Centre at St. James's University Hospital	Leeds	England

Sponsors (1)

Lead Sponsor	Collaborator
Children's Cancer and Leukaemia Group

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate by MRI after course 3			No
Secondary	Second surgery or additional radiotherapy in responding patients as assessed by MRI scan after course 3 or 6			No