NCT00278252

Brief Summary

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2001

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

January 16, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 18, 2006

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Last Updated

August 7, 2013

Status Verified

June 1, 2009

Enrollment Period

9 years

First QC Date

January 16, 2006

Last Update Submit

August 6, 2013

Conditions

Keywords

recurrent childhood ependymomachildhood infratentorial ependymomachildhood supratentorial ependymoma

Outcome Measures

Primary Outcomes (1)

  • Response rate by MRI after course 3

Secondary Outcomes (1)

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

Interventions

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, LS9 7TF, United Kingdom

RECRUITING

Related Publications (1)

  • Apps JR, Maycock S, Ellison DW, Jaspan T, Ritzmann TA, Macarthur D, Mallucci C, Wheatley K, Veal GJ, Grundy RG, Picton S. Phase II study of intravenous etoposide in patients with relapsed ependymoma (CNS 2001 04). Neurooncol Adv. 2022 Apr 13;4(1):vdac053. doi: 10.1093/noajnl/vdac053. eCollection 2022 Jan-Dec.

MeSH Terms

Conditions

Central Nervous System NeoplasmsFamilial ependymoma

Interventions

Etoposide

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System Diseases

Intervention Hierarchy (Ancestors)

PodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsGlucosidesGlycosidesCarbohydrates

Study Officials

  • Linda S. Lashford

    The Christie NHS Foundation Trust

  • Susan V. Picton, MD

    Leeds Cancer Centre at St. James's University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 16, 2006

First Posted

January 18, 2006

Study Start

July 1, 2001

Primary Completion

July 1, 2010

Last Updated

August 7, 2013

Record last verified: 2009-06

Locations