High-Dose Methotrexate in Treating Young Patients With Residual Ependymoma

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Brain and Central Nervous System Tumors

Intervention / Treatment
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* Drug: methotrexate
* Procedure: adjuvant therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: methotrexate|nan|
|Procedure: adjuvant therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Activity of high-dose methotrexate at 6 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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childhood infratentorial ependymoma, childhood supratentorial ependymoma, newly diagnosed childhood ependymoma