Phase II Study of High-Dose Methotrexate in Children With Residual Ependymoma
N/A
2 Years
Both
Brain and Central Nervous System Tumors
Trial Information
Phase II Study of High-Dose Methotrexate in Children With Residual Ependymoma
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.
Inclusion 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
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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Activity of high-dose methotrexate at 6 weeks
Safety Issue:
No
Principal Investigator
Martin W. English, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Birmingham Children's Hospital
Authority:
United States: Federal Government
Study ID:
CDR0000454548
NCT ID:
NCT00287924
Start Date:
March 2005
Completion Date:
Related Keywords:
- Brain and Central Nervous System Tumors
- childhood infratentorial ependymoma
- childhood supratentorial ependymoma
- newly diagnosed childhood ependymoma
- Ependymoma
- Nervous System Neoplasms
- Central Nervous System Neoplasms
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