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High-Dose Methotrexate in Treating Young Patients With Residual Ependymoma

Sponsor
Children's Cancer and Leukaemia Group (Other)
Overall Status
Unknown status
CT.gov ID
NCT00287924
Collaborator
(none)
29
Enrollment
21
Locations
1.4
Patients Per Site

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as methotrexate, 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 high-dose methotrexate works in treating young patients with residual ependymoma.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

OBJECTIVES:

Primary

  • Determine the activity of high-dose methotrexate as upfront-window therapy in young patients with residual ependymoma.

Secondary

  • Assess the reasons why primary surgery was complete/incomplete in these patients.

  • Assess the feasibility and toxicity of second-look surgery after 3 courses of high-dose methotrexate in cases where initial surgery was incomplete.

OUTLINE: This is a multicenter, open-label study.

Patients receive high-dose methotrexate IV continuously over 24 hours on days 0, 14, and 28 in the absence of disease progression or unacceptable toxicity. Patients then proceed to further chemotherapy on protocol UKCCSG-CNS-9204.

After completion of study treatment, patients are followed periodically for 9 years.

PROJECTED ACCRUAL: A total of 29 patients will be accrued for this study.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
29 participants
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase II Study of High-Dose Methotrexate in Children With Residual Ependymoma
Study Start Date :
Mar 1, 2005
Anticipated Primary Completion Date :
Mar 1, 2010

Outcome Measures

Primary Outcome Measures

  1. Activity of high-dose methotrexate at 6 weeks []

Secondary Outcome Measures

  1. Assess reasons why primary surgery is complete or incomplete at diagnosis []

  2. Feasibility and toxicity of second look surgery after course 3 at 2 months []

  3. Compare functional imaging studies of ependymomas with biological characteristics of the tumors at diagnosis []

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 2 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
DISEASE CHARACTERISTICS:

  • Histologically confirmed ependymoma, including the following histologic variants:

  • Cellular

  • Papillary

  • Clear-cell

  • Tanycytic

  • Anaplastic (malignant) ependymoma

  • The following diagnoses are excluded:

  • Myxopapillary ependymoma

  • Subependymomas

  • Ependymoblastomas

  • Primitive neuroectodermal tumors (PNETs)

  • Other neuroepithelial tumors

  • Choroid plexus tumors

  • Germ cell tumors

  • Residual measurable ependymoma after maximal surgical resection, including second-look surgery, if deemed necessary

  • Has undergone surgical resection within the past 3 weeks

PATIENT CHARACTERISTICS:

  • At least 3 months to under 3 years of age

  • Neutrophil count > 1,000/mm^3

  • Platelet count > 100,000/mm^3

  • Able to tolerate chemotherapy

  • No co-existent unrelated disease (i.e., renal or hematological) that would preclude chemotherapy treatment

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

  • Recovered from prior surgery

  • No previous chemotherapy

  • Previous steroids allowed

  • No previous radiotherapy

Contacts and Locations

Locations

Site City State Country Postal Code
1 Our Lady's Hospital for Sick Children Crumlin Dublin Ireland 12
2 Birmingham Children's Hospital Birmingham England United Kingdom B4 6NH
3 Institute of Child Health at University of Bristol Bristol England United Kingdom BS2 8AE
4 Addenbrooke's Hospital Cambridge England United Kingdom CB2 2QQ
5 Leeds Cancer Centre at St. James's University Hospital Leeds England United Kingdom LS9 7TF
6 Leicester Royal Infirmary Leicester England United Kingdom LE1 5WW
7 Royal Liverpool Children's Hospital, Alder Hey Liverpool England United Kingdom L12 2AP
8 Royal London Hospital London England United Kingdom E1 1BB
9 Great Ormond Street Hospital for Children London England United Kingdom WC1N 3JH
10 Royal Manchester Children's Hospital Manchester England United Kingdom M27 4HA
11 Sir James Spence Institute of Child Health at Royal Victoria Infirmary Newcastle-Upon-Tyne England United Kingdom NE1 4LP
12 Queen's Medical Centre Nottingham England United Kingdom NG7 2UH
13 Oxford Radcliffe Hospital Oxford England United Kingdom 0X3 9DU
14 Children's Hospital - Sheffield Sheffield England United Kingdom S10 2TH
15 Southampton General Hospital Southampton England United Kingdom SO16 6YD
16 Royal Marsden - Surrey Sutton England United Kingdom SM2 5PT
17 Royal Belfast Hospital for Sick Children Belfast Northern Ireland United Kingdom BT12 6BE
18 Royal Aberdeen Children's Hospital Aberdeen Scotland United Kingdom AB25 2ZG
19 Royal Hospital for Sick Children Edinburgh Scotland United Kingdom EH9 1LF
20 Royal Hospital for Sick Children Glasgow Scotland United Kingdom G3 8SJ
21 Childrens Hospital for Wales Cardiff Wales United Kingdom CF14 4XW

Sponsors and Collaborators

  • Children's Cancer and Leukaemia Group

Investigators

  • Study Chair: Martin W. English, MD, Birmingham Children's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00287924
Other Study ID Numbers:
  • CDR0000454548
  • CCLG-CNS-2005-03
  • EU-20581
  • EUDRACT-2004-004405-14
First Posted:
Feb 7, 2006
Last Update Posted:
Sep 17, 2013
Last Verified:
Jun 1, 2009
Keywords provided by , ,
childhood infratentorial ependymoma
childhood supratentorial ependymoma
newly diagnosed childhood ependymoma
Additional relevant MeSH terms:
Ependymoma
Nervous System Neoplasms
Central Nervous System Neoplasms
Methotrexate

Study Results

No Results Posted as of Sep 17, 2013