Etoposide in Treating Young Patients With Relapsed Ependymoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00278252
First received: January 16, 2006
Last updated: August 6, 2013
Last verified: June 2009
  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 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Intravenous Etoposide in Patients With Relapsed Ependymoma

Resource links provided by NLM:


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 2010 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00278252

Locations
United Kingdom
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

ClinicalTrials.gov Identifier: NCT00278252     History of Changes
Other Study ID Numbers: CCLG-CNS-2001-4, CDR0000454543, EU-20576
Study First Received: January 16, 2006
Last Updated: August 6, 2013
Health Authority: Unspecified

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

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

ClinicalTrials.gov processed this record on July 29, 2014