Phase 2
Completed N=72
A Study of Pemetrexed in Children With Recurrent Cancer
Osteosarcoma · Medulloblastoma · Sarcoma, Ewing's · Neuroblastoma (Measurable Disease)
Source: ClinicalTrials.gov NCT00520936 ↗
Enrolled (actual)
72
Serious AEs
29.2%
Results posted
Feb 2011
Primary outcomePrimary: Percentage of Participants With Overall Tumor Response (Response Rate) — 0; 0; 0; 0 Percentage of Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Overall Tumor Response (Response Rate) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Patients With Adverse Events, Discontinuations, or Deaths Possibly Due to Study Drug |
3; 2; 0; 2; 3; 2 | — |
| SECONDARY Pharmacogenomics - Measure the Response of Genes Related to Toxicity |
— | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00520936). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.