Etoposide in Treating Young Patients With Relapsed Ependymoma

Children's Cancer and Leukaemia Group

Status and phase: Unknown; Phase 2

Conditions: Brain and Central Nervous System Tumors

Treatments: Drug: etoposide; Procedure: conventional surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT00278252

EU-20576

CDR0000454543 (Registry Identifier)

CCLG-CNS-2001-4

Details and patient eligibility

About

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.

Full 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.

Enrollment: 14 estimated patients

Sex: All

Ages: Under 21 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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