A Study of Pemetrexed in Children With Recurrent Cancer

Study Overview
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Brief Summary
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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.

Official Title
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A Phase II Study of Pemetrexed in Children With Recurrent Malignancies

Conditions
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Osteosarcoma, Medulloblastoma, Sarcoma, Ewing's, Neuroblastoma (Measurable Disease), Neuroblastoma (Metaiodobenzylguanidine, Positive Evaluable), Rhabdomyosarcoma, Ependymoma, Non-brainstem High-grade Glioma

Intervention / Treatment
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* Drug: pemetrexed


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pemetrexed<br> | Drug: pemetrexed<br>* 1910 milligrams per meter squared (mg/m^2) (or 60 milligrams per kilogram [mg/kg] if patient <12 months old), intravenous (IV), for 21 days x 17 cycles<br>* Other names: Alimta;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Overall Tumor Response (Response Rate) | 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. | baseline to measured progressive disease (up to 1 year) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Adverse Events, Discontinuations, or Deaths Possibly Due to Study Drug | AdEERS= Adverse Event Expedited Reporting System; AE = adverse event. Patients may be counted in more than 1 category. Includes events that were considered possibly related to study drug (PRSD) as judged by the investigator. | every cycle (up to 2 years and 7 months) | 
| Pharmacogenomics - Measure the Response of Genes Related to Toxicity | The pharmacogenomics outcomes examining the correlation between the presence of the methylene tetrahydrofolate reductase gene and the presence of a polymorphism in the thymidylate synthase (TS) gene and/or gene promoter and toxicity were optional and will not be reported here. Results of this optional research may be reported in the future by the Children's Oncology Group in the peer-reviewed literature. | baseline |