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
Recruitment status was Recruiting
Sponsor:
Children's Cancer and Leukaemia Group
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00278252
First received: January 16, 2006
Last updated: July 14, 2009
Last verified: June 2009
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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) |
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 | |
| 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: | CDR0000454543, CCLG-CNS-2001-4, EU-20576 |
| Study First Received: | January 16, 2006 |
| Last Updated: | July 14, 2009 |
| 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 May 16, 2013