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High-Dose Methotrexate in Treating Young Patients With Residual Ependymoma

Primary Purpose

Brain and Central Nervous System Tumors

Status
Unknown status
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
methotrexate
adjuvant therapy
Sponsored by
Children's Cancer and Leukaemia Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring childhood infratentorial ependymoma, childhood supratentorial ependymoma, newly diagnosed childhood ependymoma

Eligibility Criteria

undefined - 2 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Our Lady's Hospital for Sick Children Crumlin
  • Birmingham Children's Hospital
  • Institute of Child Health at University of Bristol
  • Addenbrooke's Hospital
  • Leeds Cancer Centre at St. James's University Hospital
  • Leicester Royal Infirmary
  • Royal Liverpool Children's Hospital, Alder Hey
  • Royal London Hospital
  • Great Ormond Street Hospital for Children
  • Royal Manchester Children's Hospital
  • Sir James Spence Institute of Child Health at Royal Victoria Infirmary
  • Queen's Medical Centre
  • Oxford Radcliffe Hospital
  • Children's Hospital - Sheffield
  • Southampton General Hospital
  • Royal Marsden - Surrey
  • Royal Belfast Hospital for Sick Children
  • Royal Aberdeen Children's Hospital
  • Royal Hospital for Sick Children
  • Royal Hospital for Sick Children
  • Childrens Hospital for Wales

Outcomes

Primary Outcome Measures

Activity of high-dose methotrexate at 6 weeks

Secondary Outcome Measures

Assess reasons why primary surgery is complete or incomplete at diagnosis
Feasibility and toxicity of second look surgery after course 3 at 2 months
Compare functional imaging studies of ependymomas with biological characteristics of the tumors at diagnosis

Full Information

First Posted
February 6, 2006
Last Updated
September 16, 2013
Sponsor
Children's Cancer and Leukaemia Group
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1. Study Identification

Unique Protocol Identification Number
NCT00287924
Brief Title
High-Dose Methotrexate in Treating Young Patients With Residual Ependymoma
Official Title
Phase II Study of High-Dose Methotrexate in Children With Residual Ependymoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Unknown status
Study Start Date
March 2005 (undefined)
Primary Completion Date
March 2010 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Children's Cancer and Leukaemia Group

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors
Keywords
childhood infratentorial ependymoma, childhood supratentorial ependymoma, newly diagnosed childhood ependymoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
29 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
methotrexate
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Primary Outcome Measure Information:
Title
Activity of high-dose methotrexate at 6 weeks
Secondary Outcome Measure Information:
Title
Assess reasons why primary surgery is complete or incomplete at diagnosis
Title
Feasibility and toxicity of second look surgery after course 3 at 2 months
Title
Compare functional imaging studies of ependymomas with biological characteristics of the tumors at diagnosis

10. Eligibility

Sex
All
Maximum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin W. English, MD
Organizational Affiliation
Birmingham Children's Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Our Lady's Hospital for Sick Children Crumlin
City
Dublin
ZIP/Postal Code
12
Country
Ireland
Facility Name
Birmingham Children's Hospital
City
Birmingham
State/Province
England
ZIP/Postal Code
B4 6NH
Country
United Kingdom
Facility Name
Institute of Child Health at University of Bristol
City
Bristol
State/Province
England
ZIP/Postal Code
BS2 8AE
Country
United Kingdom
Facility Name
Addenbrooke's Hospital
City
Cambridge
State/Province
England
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
Facility Name
Leeds Cancer Centre at St. James's University Hospital
City
Leeds
State/Province
England
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Leicester Royal Infirmary
City
Leicester
State/Province
England
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
Royal Liverpool Children's Hospital, Alder Hey
City
Liverpool
State/Province
England
ZIP/Postal Code
L12 2AP
Country
United Kingdom
Facility Name
Royal London Hospital
City
London
State/Province
England
ZIP/Postal Code
E1 1BB
Country
United Kingdom
Facility Name
Great Ormond Street Hospital for Children
City
London
State/Province
England
ZIP/Postal Code
WC1N 3JH
Country
United Kingdom
Facility Name
Royal Manchester Children's Hospital
City
Manchester
State/Province
England
ZIP/Postal Code
M27 4HA
Country
United Kingdom
Facility Name
Sir James Spence Institute of Child Health at Royal Victoria Infirmary
City
Newcastle-Upon-Tyne
State/Province
England
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Facility Name
Queen's Medical Centre
City
Nottingham
State/Province
England
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Facility Name
Oxford Radcliffe Hospital
City
Oxford
State/Province
England
ZIP/Postal Code
0X3 9DU
Country
United Kingdom
Facility Name
Children's Hospital - Sheffield
City
Sheffield
State/Province
England
ZIP/Postal Code
S10 2TH
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southampton
State/Province
England
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Royal Marsden - Surrey
City
Sutton
State/Province
England
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Royal Belfast Hospital for Sick Children
City
Belfast
State/Province
Northern Ireland
ZIP/Postal Code
BT12 6BE
Country
United Kingdom
Facility Name
Royal Aberdeen Children's Hospital
City
Aberdeen
State/Province
Scotland
ZIP/Postal Code
AB25 2ZG
Country
United Kingdom
Facility Name
Royal Hospital for Sick Children
City
Edinburgh
State/Province
Scotland
ZIP/Postal Code
EH9 1LF
Country
United Kingdom
Facility Name
Royal Hospital for Sick Children
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G3 8SJ
Country
United Kingdom
Facility Name
Childrens Hospital for Wales
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF14 4XW
Country
United Kingdom

12. IPD Sharing Statement

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High-Dose Methotrexate in Treating Young Patients With Residual Ependymoma

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