NCT00520936 · CITED IN SOURCE DOCUMENTS

A Study of Pemetrexed in Children With Recurrent Cancer

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2011-02-25

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Percentage of Participants With Overall Tumor Response (Response Rate)

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outcome · POSTED

Number of Patients With Adverse Events, Discontinuations, or Deaths Possibly Due to Study Drug

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outcome · POSTED

Pharmacogenomics - Measure the Response of Genes Related to Toxicity

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

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
healthy Volunteers: false
maximum Age: 22 Years
sex: ALL
std Ages: CHILD
ADULT

Treatment arms and interventions

arm Groups

intervention Names
Drug: pemetrexed
label
Pemetrexed
type
EXPERIMENTAL

interventions

arm Group Labels
Pemetrexed
description
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
name
pemetrexed
other Names
LY 231514
Alimta
type
DRUG

Study design

allocation

NON_RANDOMIZED

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 72
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

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.
measure
Percentage of Participants With Overall Tumor Response (Response Rate)
time Frame
baseline to measured progressive disease (up to 1 year)

secondary Outcomes

description
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.
measure
Number of Patients With Adverse Events, Discontinuations, or Deaths Possibly Due to Study Drug
time Frame
every cycle (up to 2 years and 7 months)
description
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.
measure
Pharmacogenomics - Measure the Response of Genes Related to Toxicity
time Frame
baseline

Full study description

brief 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.

Source references