Official Title: “Phase II Study of High-Dose Methotrexate in Children With Residual Ependymoma”

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.

Study Type: Interventional

Study Design: Treatment, Open Label

Study Primary Completion Date: March 2010

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.

Intervention(s) in this Clinical Trial

• Drug: methotrexate
• Procedure: adjuvant therapy

Primary Measures

• Activity of high-dose methotrexate at 6 weeks
  • Safety Issue?: No

Secondary Measures

• Assess reasons why primary surgery is complete or incomplete at diagnosis
  • Safety Issue?: No
• Feasibility and toxicity of second look surgery after course 3 at 2 months
  • Safety Issue?: Yes
• Compare functional imaging studies of ependymomas with biological characteristics of the tumors at diagnosis
  • Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: 2 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Children's Cancer and Leukaemia Group

Overall Clinical Trial Officials and Contacts

Martin W. English, MD Study Chair Birmingham Children's Hospital  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00287924

Study ID Number: CDR0000454548

ClinicalTrials.gov Identifier: NCT00287924

Health Authority: Unspecified

Clinical trial summary from the National Cancer Institute's PDQ® database