Trials Sponsors Conditions Drugs Pricing

Conditions

Brain and Central Nervous System Tumors

Keywords

childhood infratentorial ependymomachildhood supratentorial ependymomanewly diagnosed childhood ependymoma

Outcome Measures

Primary Outcomes (1)

Activity of high-dose methotrexate at 6 weeks

Secondary Outcomes (3)

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

Interventions

methotrexateDrug

adjuvant therapyProcedure

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

AgeUp to 2 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

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

Sponsors & Collaborators

Children's Cancer and Leukaemia Group
Otherlead

Study Sites (21)

Our Lady's Hospital for Sick Children Crumlin

Dublin, 12, Ireland

Birmingham Children's Hospital

Birmingham, England, B4 6NH, United Kingdom

Institute of Child Health at University of Bristol

Bristol, England, BS2 8AE, United Kingdom

Addenbrooke's Hospital

Cambridge, England, CB2 2QQ, United Kingdom

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, LS9 7TF, United Kingdom

Leicester Royal Infirmary

Leicester, England, LE1 5WW, United Kingdom

Royal Liverpool Children's Hospital, Alder Hey

MeSH Terms

Conditions

Central Nervous System Neoplasms

Interventions

MethotrexateChemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System Diseases

Intervention Hierarchy (Ancestors)

AminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

Martin W. English, MD
Birmingham Children's Hospital
STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

February 6, 2006

First Posted

February 7, 2006

Study Start

March 2005

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

March 2010

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

High-Dose Methotrexate in Treating Young Patients With Residual Ependymoma

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (21)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (21)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Source record

Locations