High-Dose Methotrexate in Treating Young Patients With Residual Ependymoma

Brain and Central Nervous System Tumors Clinical Trial

Official title:

Phase II Study of High-Dose Methotrexate in Children With Residual Ependymoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00287924
• Other study ID #: CDR0000454548
• Secondary ID: CCLG-CNS-2005-03
• Status: Active, not recruiting
• Phase: Phase 2
• First received: February 6, 2006
• Last updated: September 16, 2013
• Start date: March 2005

Study information

• Verified date: June 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 29
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 2 Years

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Ependymoma
• Nervous System Neoplasms

Intervention

Drug:
• methotrexate

Procedure:
• adjuvant therapy

Locations

Country	Name	City	State
Ireland	Our Lady's Hospital for Sick Children Crumlin	Dublin
United Kingdom	Royal Aberdeen Children's Hospital	Aberdeen	Scotland
United Kingdom	Royal Belfast Hospital for Sick Children	Belfast	Northern Ireland
United Kingdom	Birmingham Children's Hospital	Birmingham	England
United Kingdom	Institute of Child Health at University of Bristol	Bristol	England
United Kingdom	Addenbrooke's Hospital	Cambridge	England
United Kingdom	Childrens Hospital for Wales	Cardiff	Wales
United Kingdom	Royal Hospital for Sick Children	Edinburgh	Scotland
United Kingdom	Royal Hospital for Sick Children	Glasgow	Scotland
United Kingdom	Leeds Cancer Centre at St. James's University Hospital	Leeds	England
United Kingdom	Leicester Royal Infirmary	Leicester	England
United Kingdom	Royal Liverpool Children's Hospital, Alder Hey	Liverpool	England
United Kingdom	Great Ormond Street Hospital for Children	London	England
United Kingdom	Royal London Hospital	London	England
United Kingdom	Royal Manchester Children's Hospital	Manchester	England
United Kingdom	Sir James Spence Institute of Child Health at Royal Victoria Infirmary	Newcastle-Upon-Tyne	England
United Kingdom	Queen's Medical Centre	Nottingham	England
United Kingdom	Oxford Radcliffe Hospital	Oxford	England
United Kingdom	Children's Hospital - Sheffield	Sheffield	England
United Kingdom	Southampton General Hospital	Southampton	England
United Kingdom	Royal Marsden - Surrey	Sutton	England

Sponsors (1)

Lead Sponsor	Collaborator
Children's Cancer and Leukaemia Group

Countries where clinical trial is conducted

Ireland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Activity of high-dose methotrexate at 6 weeks			No
Secondary	Assess reasons why primary surgery is complete or incomplete at diagnosis			No
Secondary	Feasibility and toxicity of second look surgery after course 3 at 2 months			Yes
Secondary	Compare functional imaging studies of ependymomas with biological characteristics of the tumors at diagnosis			No