Etoposide in Treating Young Patients With Relapsed Ependymoma

Overview

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 Title of Study: “Phase II Study of Intravenous Etoposide in Patients With Relapsed Ependymoma”

Study Type

  • Study Type: Interventional
  • Study Design
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2010

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.

Interventions

  • Drug: etoposide
  • Procedure: conventional surgery

Clinical Trial Outcome Measures

Primary Measures

  • Response rate by MRI after course 3

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 21 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Children’s Cancer and Leukaemia Group
  • Overall Official(s)
    • Linda S. Lashford, , The Christie NHS Foundation Trust
    • Susan V. Picton, MD, Study Chair, Leeds Cancer Centre at St. James’s University Hospital

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