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	Active	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

Ireland
	Dublin
	Our Lady's Hospital for Sick Children Crumlin
		Fin Breatnach, MD, FRCPE	Ph:  353-1-409-6659
			Email: fin.breatnach@olhsc.ie
United Kingdom
England
	Birmingham
	Birmingham Children's Hospital
		Martin English, MD	Ph:  44-121-333-8412
			Email: martin.english@bch.nhs.uk
	Bristol
	Institute of Child Health at University of Bristol
		M. C. G. Stevens, MD	Ph:  44-117-342-0205
			Email: m.stevens@bristol.ac.uk
	Cambridge
	Addenbrooke's Hospital
		James Nicholson, DM, MA, MRCPCH	Ph:  44-1223-256-298
			Email: james.nicholson@addenbrookes.nhs.uk
	Leeds
	Leeds Cancer Centre at St. James's University Hospital
		Susan Picton, MD	Ph:  44-11-32-064-985
	Leicester
	Leicester Royal Infirmary
		Mabrouk Madi, MD	Ph:  44-116-258-5959
	Liverpool
	Royal Liverpool Children's Hospital, Alder Hey
		Barry Pizer, MD	Ph:  44-151-252-5294
			Email: bpizer@liv.ac.uk
	London
	Great Ormond Street Hospital for Children
		Anthony Michalski, MD	Ph:  44-20-7829-7924
			Email: michaa@gosh.nhs.uk
	Royal London Hospital
		Ananth Shankar, MD	Ph:  44-20-7380-9950
			Email: a.shankar@cancer.org.uk
	Manchester
	Royal Manchester Children's Hospital
		Bernadette Brennan, MD	Ph:  44-161-922-2227
			Email: bernadette.brennan@cmmc.nhs.uk
	Newcastle-Upon-Tyne
	Sir James Spence Institute of Child Health at Royal Victoria Infirmary
		Simon Bailey, MD	Ph:  44-191-282-5395
	Nottingham
	Queen's Medical Centre
		David Walker	Ph:  44-115-924-9924 ext 61727
			Email: david.walker@nottingham.ac.uk
	Oxford
	Oxford Radcliffe Hospital
		Kate Wheeler, MD	Ph:  44-186-522-1066
	Sheffield
	Children's Hospital - Sheffield
		Anna Jenkins, MD	Ph:  44-114-271-7366
	Southampton
	Southampton General Hospital
		Gary Nicolin, MD	Ph:  44-2380-791-101
	Sutton
	Royal Marsden - Surrey
		Darren Hargrave, MD	Ph:  44-20-8661-3455
Northern Ireland
	Belfast
	Royal Belfast Hospital for Sick Children
		Anthony McCarthy, MD	Ph:  44-289-063-3631
			Email: anthonymcarthy@royalhospital.n.i.nhs.uk
Scotland
	Aberdeen
	Royal Aberdeen Children's Hospital
		Derek King, MD	Ph:  44-1224-681-818
	Edinburgh
	Royal Hospital for Sick Children
		W. Hamish Wallace, MD	Ph:  44-131-536-0426
	Glasgow
	Royal Hospital for Sick Children
		Milind Ronghe, MD	Ph:  44-141-201-9309
Wales
	Cardiff
	Childrens Hospital for Wales
		Heidi Traunecker, MD, PhD	Ph:  44-29-2074-2285
			Email: heidi.traunecker@cardiffandvale.wales.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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