Clinical trial · Interventional
High-Dose Methotrexate in Treating Young Patients With Residual Ependymoma
Phase II Study of High-Dose Methotrexate in Children With Residual Ependymoma
NCT00287924CI-TRIAL-00012143unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain and Central Nervous System Tumors | Central Nervous System Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| methotrexate | Drug | Methotrexate | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Activity of high-dose methotrexate at 6 weeks
Secondary outcomes (3)
- measure
- Assess reasons why primary surgery is complete or incomplete at diagnosis
- measure
- Feasibility and toxicity of second look surgery after course 3 at 2 months
- measure
- Compare functional imaging studies of ependymomas with biological characteristics of the tumors at diagnosis
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 2 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.