Clinical trial · Interventional
A Study of Pemetrexed in Children With Recurrent Cancer
A Phase II Study of Pemetrexed in Children With Recurrent Malignancies
NCT00520936CI-TRIAL-00004468completedPhase 2Results postedClinicalTrials.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)
To determine the response rate of pemetrexed given every 21 days for the treatment of children with relapsed or refractory osteosarcoma, Ewing's sarcoma/peripheral primitive neuroectodermal tumors (PNET), rhabdomyosarcoma, neuroblastoma, ependymoma, medulloblastoma/supratentorial PNET or non-brain stem high-grade glioma.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ependymoma | Ependymoma | ONTOLOGY_EXACT | 0.90 |
| Medulloblastoma | Medulloblastoma | CURATED_BROADER | 0.80 |
| Neuroblastoma (Measurable Disease) | Neuroblastoma | ONTOLOGY_EXACT | 0.85 |
| Neuroblastoma (Metaiodobenzylguanidine | — | UNRESOLVED | — |
| Non-brainstem High-grade Glioma | — | UNRESOLVED | — |
| Osteosarcoma | Osteosarcoma | ONTOLOGY_EXACT | 0.90 |
| Positive Evaluable) | — | UNRESOLVED | — |
| Rhabdomyosarcoma | Rhabdomyosarcoma | ONTOLOGY_EXACT | 0.90 |
| Sarcoma, Ewing's | Ewing Sarcoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| pemetrexed | Drug | Pemetrexed | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pemetrexed
- interventionNames
- Drug: pemetrexed
Primary outcomes (1)
- measure
- Percentage of Participants With Overall Tumor Response (Response Rate)
- timeFrame
- baseline to measured progressive disease (up to 1 year)
- description
- Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response = disappearance of all target lesions. Partial Response = 30% decrease in sum of longest diameter of target lesions. Response rate (percent \[%\])= (number of participants with complete response (CR) or partial response (PR) in stratum/number of participants in stratum)\*100.
Secondary outcomes (2)
- measure
- Number of Patients With Adverse Events, Discontinuations, or Deaths Possibly Due to Study Drug
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 22 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have osteosarcoma, Ewing's sarcoma, medulloblastoma, neuroblastoma, rhabdomyosarcoma, ependymoma or high-grade non-brainstem glioma * Measurable disease * Eastern Cooperative Oncology Group (ECOG) performance 0,1,2 * Adequate renal, liver and bone marrow function * Patient's current disease state must be one with no known curative therapy or therapy proven to prolong survival with an acceptable quality of life Exclusion Criteria: * Growth factors that support platelet or white cell number or function must not have been administered within the last 7 days prior to enrollment (14 days if Neulasta) * Patients with central nervous system (CNS) tumors who have not been on a stable or decreasing dose of dexamethasone or other corticosteroid for 7 days prior to enrollment * Patients with uncontrolled infection * Patients who have received pemetrexed previously * Patients with pleural effusions or ascites
References
Publications (0)
Data not yet available
No reference posted for this study.