High-Dose Methotrexate in Treating Young Patients With Residual Ependymoma

NCT00287924 | Unknown Phase 2

• 4 other identifiers: CDR0000454548CCLG-CNS-2005-03EU-20581EUDRACT-2004-004405-14
• Study Type: interventional
• Target: 29
• Locations: 2 countries
• Sites: 21

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.

Conditions

Brain and Central Nervous System Tumors

Keywords

childhood infratentorial ependymoma; childhood supratentorial ependymoma; newly diagnosed childhood ependymoma

Outcome Measures

Primary Outcomes (1)

• Activity of high-dose methotrexate at 6 weeks

Secondary Outcomes (3)

• 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

Interventions

methotrexate DRUG

adjuvant therapy PROCEDURE

Eligibility Criteria

• Age: Up to 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Children's Cancer and Leukaemia Group: lead

Study Sites (21)

Our Lady's Hospital for Sick Children Crumlin

Dublin, 12, Ireland

Location

Birmingham Children's Hospital

Birmingham, England, B4 6NH, United Kingdom

Location

Institute of Child Health at University of Bristol

Bristol, England, BS2 8AE, United Kingdom

Location

Addenbrooke's Hospital

Cambridge, England, CB2 2QQ, United Kingdom

Location

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, LS9 7TF, United Kingdom

Location

Leicester Royal Infirmary

Leicester, England, LE1 5WW, United Kingdom

Location

Royal Liverpool Children's Hospital, Alder Hey

Liverpool, England, L12 2AP, United Kingdom

Location

Royal London Hospital

London, England, E1 1BB, United Kingdom

Location

Great Ormond Street Hospital for Children

London, England, WC1N 3JH, United Kingdom

Location

Royal Manchester Children's Hospital

Manchester, England, M27 4HA, United Kingdom

Location

Sir James Spence Institute of Child Health at Royal Victoria Infirmary

Newcastle upon Tyne, England, NE1 4LP, United Kingdom

Location

Queen's Medical Centre

Nottingham, England, NG7 2UH, United Kingdom

Location

Oxford Radcliffe Hospital

Oxford, England, 0X3 9DU, United Kingdom

Location

Children's Hospital - Sheffield

Sheffield, England, S10 2TH, United Kingdom

Location

Southampton General Hospital

Southampton, England, SO16 6YD, United Kingdom

Location

Royal Marsden - Surrey

Sutton, England, SM2 5PT, United Kingdom

Location

Royal Belfast Hospital for Sick Children

Belfast, Northern Ireland, BT12 6BE, United Kingdom

Location

Royal Aberdeen Children's Hospital

Aberdeen, Scotland, AB25 2ZG, United Kingdom

Location

Royal Hospital for Sick Children

Edinburgh, Scotland, EH9 1LF, United Kingdom

Location

Royal Hospital for Sick Children

Glasgow, Scotland, G3 8SJ, United Kingdom

Location

Childrens Hospital for Wales

Cardiff, Wales, CF14 4XW, United Kingdom

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms

Interventions

Methotrexate; Chemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Martin W. English, MD

  Birmingham Children's Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 6, 2006
• First Posted: February 7, 2006
• Study Start: March 1, 2005
• Primary Completion: March 1, 2010
• Last Updated: September 17, 2013

Record last verified: 2009-06

Locations

IE (1); GB (20)