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Etoposide in Treating Young Patients With Relapsed Ependymoma
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), April 2008
First Received: January 16, 2006   Last Updated: February 6, 2009   History of Changes
Sponsored by: Children's Cancer and Leukaemia Group
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00278252
  Purpose

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.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Drug: etoposide
Procedure: conventional surgery
Phase II

MedlinePlus related topics: Cancer Surgery
Drug Information available for: Etoposide Etoposide phosphate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Phase II Study of Intravenous Etoposide in Patients With Relapsed Ependymoma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response rate by MRI after course 3 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Second surgery or additional radiotherapy in responding patients as assessed by MRI scan after course 3 or 6 [ Designated as safety issue: No ]

Estimated Enrollment: 14
Study Start Date: July 2001
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00278252

Locations
United Kingdom, England
Leeds Cancer Centre at St. James's University Hospital Recruiting
Leeds, England, United Kingdom, LS9 7TF
Contact: Susan V. Picton, MD     44-11-32-064-985        
Sponsors and Collaborators
Children's Cancer and Leukaemia Group
Investigators
Investigator: Linda S. Lashford Christie Hospital NHS Foundation Trust
Study Chair: Susan V. Picton, MD Leeds Cancer Centre at St. James's University Hospital
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000454543, CCLG-CNS-2001-4, EU-20576
Study First Received: January 16, 2006
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00278252     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
recurrent childhood ependymoma
childhood infratentorial ependymoma
childhood supratentorial ependymoma

Study placed in the following topic categories:
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Glioma
Central Nervous System Neoplasms
Antineoplastic Agents, Phytogenic
Etoposide phosphate
Etoposide
Recurrence
Ependymoma
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Antineoplastic Agents
Neoplasms, Nerve Tissue
Nervous System Diseases
Central Nervous System Neoplasms
Etoposide phosphate
Pharmacologic Actions
Ependymoma
Neuroectodermal Tumors
Neoplasms
Neoplasms by Site
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Glioma
Neoplasms, Neuroepithelial
Antineoplastic Agents, Phytogenic
Etoposide
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009