Status:
UNKNOWN
High-Dose Methotrexate in Treating Young Patients With Residual Ependymoma
Lead Sponsor:
Children's Cancer and Leukaemia Group
Conditions:
Brain and Central Nervous System Tumors
Eligibility:
All Genders
Up to 2 years
Phase:
PHASE2
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 pha...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00287924
Start Date
March 1 2005
Last Update
September 17 2013
Active Locations (21)
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1
Our Lady's Hospital for Sick Children Crumlin
Dublin, Ireland, 12
2
Birmingham Children's Hospital
Birmingham, England, United Kingdom, B4 6NH
3
Institute of Child Health at University of Bristol
Bristol, England, United Kingdom, BS2 8AE
4
Addenbrooke's Hospital
Cambridge, England, United Kingdom, CB2 2QQ