High-Dose Methotrexate in Treating Young Patients With Residual Ependymoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00287924
First received: February 6, 2006
Last updated: September 16, 2013
Last verified: June 2009
  Purpose

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 Intervention Phase
Brain and Central Nervous System Tumors
Drug: methotrexate
Procedure: adjuvant therapy
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of High-Dose Methotrexate in Children With Residual Ependymoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Activity of high-dose methotrexate at 6 weeks [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess reasons why primary surgery is complete or incomplete at diagnosis [ Designated as safety issue: No ]
  • Feasibility and toxicity of second look surgery after course 3 at 2 months [ Designated as safety issue: Yes ]
  • Compare functional imaging studies of ependymomas with biological characteristics of the tumors at diagnosis [ Designated as safety issue: No ]

Estimated Enrollment: 29
Study Start Date: March 2005
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   up to 2 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00287924

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00287924     History of Changes
Other Study ID Numbers: CDR0000454548, CCLG-CNS-2005-03, EU-20581, EUDRACT-2004-004405-14
Study First Received: February 6, 2006
Last Updated: September 16, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
childhood infratentorial ependymoma
childhood supratentorial ependymoma
newly diagnosed childhood ependymoma

Additional relevant MeSH terms:
Ependymoma
Nervous System Neoplasms
Central Nervous System Neoplasms
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents

ClinicalTrials.gov processed this record on July 24, 2014