Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

High-Dose Methotrexate in Treating Young Patients With Residual Ependymoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	Under 3	Other	CCLG-CNS-2005-03 EU-20581, EUDRACT-2004-004405-14, NCT00287924

Objectives

Primary

1. Determine the activity of high-dose methotrexate as upfront-window therapy in young patients with residual ependymoma.

Secondary

1. Assess the reasons why primary surgery was complete/incomplete in these patients.
2. Assess the feasibility and toxicity of second-look surgery after 3 courses of high-dose methotrexate in cases where initial surgery was incomplete.

Entry 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

Prior/Concurrent Therapy:

• See Disease Characteristics
• Recovered from prior surgery
• No previous chemotherapy
• Previous steroids allowed
• No previous radiotherapy

Patient Characteristics:

• At least 3 months to under 3 years of age
• Neutrophil count > 1,000/mm³
• Platelet count > 100,000/mm³
• Able to tolerate chemotherapy
• No co-existent unrelated disease (i.e., renal or hematological) that would preclude chemotherapy treatment

Expected Enrollment

A total of 29 patients will be accrued for this study.

Outcomes

Activity of high-dose methotrexate at 6 weeks

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

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.

Trial Contact Information

Trial Lead Organizations

Children's Cancer and Leukaemia Group

Martin English, MD, Protocol chair		Ph: 44-121-333-8412 Email: martin.english@bch.nhs.uk

Related Information

PDQ® clinical trial CCLG-CNS-9204

Registry Information
Official Title		Phase II Study of High-Dose Methotrexate in Children with Residual Ependymoma
Trial Start Date		2005-03-01
Trial Completion Date		2010-03-01 (estimated)
Registered in ClinicalTrials.gov		NCT00287924
Date Submitted to PDQ		2005-09-15
Information Last Verified		2009-06-14

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