NCT00520936 · STUDY IN CONTEXT

A Study of Pemetrexed in Children With Recurrent Cancer

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

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.

All treated participants.

→

secondary · POSTED

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.

All treated participants.

→

secondary · POSTED

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.

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.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-central-nervous-system-tumors
nct id: NCT00520936
trial label: A Study of Pemetrexed in Children With Recurrent Cancer
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: regulator-cited
discovery note: Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count: 3
harms Count: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors
nct id
NCT00520936
outcome key
om-0000
source section id
NCT00520936-om-0000
source outcome index
0
endpoint
Percentage of Participants With Overall Tumor Response (Response Rate)
endpoint definition
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.
time origin
baseline to measured progressive disease (up to 1 year)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All treated participants.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors
nct id
NCT00520936
outcome key
om-0001
source section id
NCT00520936-om-0001
source outcome index
1
endpoint
Number of Patients With Adverse Events, Discontinuations, or Deaths Possibly Due to Study Drug
endpoint definition
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.
time origin
every cycle (up to 2 years and 7 months)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All treated participants.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors
nct id
NCT00520936
outcome key
om-0002
source section id
NCT00520936-om-0002
source outcome index
2
endpoint
Pharmacogenomics - Measure the Response of Genes Related to Toxicity
endpoint definition
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.
time origin
baseline
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
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.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors
nct id
NCT00520936
outcome key
om-0000
arm key
OG000
arm label
Osteosarcoma
regimen
Pemetrexed 1910 milligrams per meters squared (mg/m\^2) (or 60 milligrams per kilogram \[mg/kg\] if patient \<12 months old)
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00520936-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors
nct id
NCT00520936
outcome key
om-0000
arm key
OG001
arm label
Ewing's Sarcoma/Peripheral Primitive Neuroectodermal Tumors
regimen
Pemetrexed 1910 mg/m\^2 (or 60 mg/kg if patient \<12 months old)
analyzed count
11
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00520936-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors
nct id
NCT00520936
outcome key
om-0000
arm key
OG002
arm label
Rhabdomyosarcoma
regimen
Pemetrexed 1910 mg/m\^2 (or 60 mg/kg if patient \<12 months old)
analyzed count
9
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00520936-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors
nct id
NCT00520936
outcome key
om-0000
arm key
OG003
arm label
Neuroblastoma (Measureable Disease)
regimen
Pemetrexed 1910 mg/m\^2 (or 60 mg/kg if patient \<12 months old)
analyzed count
5
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00520936-om-0000#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors
nct id
NCT00520936
outcome key
om-0000
arm key
OG004
arm label
Neuroblastoma (Metaiodobenzylguanidine Positive Evaluable)
regimen
Pemetrexed 1910 mg/m\^2 (or 60 mg/kg if patient \<12 months old)
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00520936-om-0000#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors
nct id
NCT00520936
outcome key
om-0000
arm key
OG005
arm label
Ependymoma
regimen
Pemetrexed 1910 mg/m\^2 (or 60 mg/kg if patient \<12 months old)
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00520936-om-0000#groups/OG005
release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors
nct id
NCT00520936
outcome key
om-0000
arm key
OG006
arm label
Medulloblastoma/Supratentorial Primitive Neuroectodermal Tumor
regimen
Pemetrexed 1910 mg/m\^2 (or 60 mg/kg if patient \<12 months old)
analyzed count
11
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00520936-om-0000#groups/OG006
release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors
nct id
NCT00520936
outcome key
om-0000
arm key
OG007
arm label
Non-Brainstem High-Grade Glioma
regimen
Pemetrexed 1910 mg/m\^2 (or 60 mg/kg if patient \<12 months old)
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00520936-om-0000#groups/OG007
release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors
nct id
NCT00520936
outcome key
om-0001
arm key
OG000
arm label
Osteosarcoma
regimen
Pemetrexed 1910 milligrams per meters squared (mg/m\^2) (or 60 milligrams per kilogram \[mg/kg\] if patient \<12 months old)
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00520936-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors
nct id
NCT00520936
outcome key
om-0001
arm key
OG001
arm label
Ewing's Sarcoma/Peripheral Primitive Neuroectodermal Tumors
regimen
Pemetrexed 1910 mg/m\^2 (or 60 mg/kg if patient \<12 months old)
analyzed count
11
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00520936-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors
nct id
NCT00520936
outcome key
om-0001
arm key
OG002
arm label
Rhabdomyosarcoma
regimen
Pemetrexed 1910 mg/m\^2 (or 60 mg/kg if patient \<12 months old)
analyzed count
9
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00520936-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors
nct id
NCT00520936
outcome key
om-0001
arm key
OG003
arm label
Neuroblastoma (Measureable Disease)
regimen
Pemetrexed 1910 mg/m\^2 (or 60 mg/kg if patient \<12 months old)
analyzed count
5
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00520936-om-0001#groups/OG003

harms

release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors
nct id
NCT00520936
harm key
EG000
source section id
NCT00520936-ae
event group key
EG000
event group label
Pemetrexed
serious affected
21
serious at risk
72
other affected
10
other at risk
72
frequency threshold
1
collection period
Source null
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice