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High-Dose Methotrexate in Treating Young Patients With Residual Ependymoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00287924
Recruitment Status : Unknown
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : February 7, 2006
Last Update Posted : September 17, 2013
Sponsor:
Information provided by:
National Cancer Institute (NCI)

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
Brain and Central Nervous System Tumors Drug: methotrexate Procedure: adjuvant therapy 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : March 2005
Estimated Primary Completion Date : March 2010

Resource links provided by the National Library of Medicine





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


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 2 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00287924


Locations
Show Show 21 study locations
Sponsors and Collaborators
Children's Cancer and Leukaemia Group
Investigators
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Study Chair: Martin W. English, MD Birmingham Children's Hospital
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ClinicalTrials.gov Identifier: NCT00287924    
Other Study ID Numbers: CDR0000454548
CCLG-CNS-2005-03
EU-20581
EUDRACT-2004-004405-14
First Posted: February 7, 2006    Key Record Dates
Last Update Posted: September 17, 2013
Last Verified: June 2009
Keywords provided by National Cancer Institute (NCI):
childhood infratentorial ependymoma
childhood supratentorial ependymoma
newly diagnosed childhood ependymoma
Additional relevant MeSH terms:
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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
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors