Status:

UNKNOWN

High-Dose Methotrexate in Treating Young Patients With Residual Ependymoma

Lead Sponsor:

Children's Cancer and Leukaemia Group

Conditions:

Brain and Central Nervous System Tumors

Eligibility:

All Genders

Up to 2 years

Phase:

PHASE2

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 pha...

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 ...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    March 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    Estimated Enrollment :

    29 Patients enrolled

    Trial Details

    Trial ID

    NCT00287924

    Start Date

    March 1 2005

    Last Update

    September 17 2013

    Active Locations (21)

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    Page 1 of 6 (21 locations)

    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