Trial · NCT00520936
A Study of Pemetrexed in Children With Recurrent Cancer
NCT00520936, Phase 2, Completed, Eli Lilly and Company; results first posted 2011-02-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Pemetrexed in Children With Recurrent Cancer. Trials, record NCT00520936. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00520936
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Pemetrexed in Children With Recurrent Cancer
- NCT number
- NCT00520936
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 72 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
Osteosarcoma, Medulloblastoma, Sarcoma, Ewing's, Neuroblastoma (Measurable Disease), Neuroblastoma (Metaiodobenzylguanidine, Positive Evaluable), Rhabdomyosarcoma, Ependymoma, Non-brainstem High-grade Glioma
- Interventions
- pemetrexed
- First posted
- 2007-08-27
- Last updated
- 2011-02-25
- Results first posted
- 2011-02-23
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Overall Tumor Response (Response Rate) | baseline to measured progressive disease (up to 1 year) | 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 | Number of Patients With Adverse Events, Discontinuations, or Deaths Possibly Due to Study Drug | every cycle (up to 2 years and 7 months) | 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. |
| Secondary | Pharmacogenomics - Measure the Response of Genes Related to Toxicity | baseline | 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. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Overall Tumor Response (Response Rate) | baseline to measured progressive disease (up to 1 year) | All treated participants. | Percentage of Participants | NUMBER |
| SECONDARY | Number of Patients With Adverse Events, Discontinuations, or Deaths Possibly Due to Study Drug | every cycle (up to 2 years and 7 months) | All treated participants. | Participants | NUMBER |
| SECONDARY | Pharmacogenomics - Measure the Response of Genes Related to Toxicity | baseline | 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. | Correlation coefficient | NUMBER |
Source ClinicalTrials.gov
Results by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Overall Tumor Response (Response Rate) | Osteosarcoma | 0 | Percentage of Participants | ||
| Percentage of Participants With Overall Tumor Response (Response Rate) | Ewing's Sarcoma/Peripheral Primitive Neuroectodermal Tumors | 0 | Percentage of Participants | ||
| Percentage of Participants With Overall Tumor Response (Response Rate) | Rhabdomyosarcoma | 0 | Percentage of Participants | ||
| Percentage of Participants With Overall Tumor Response (Response Rate) | Neuroblastoma (Measureable Disease) | 0 | Percentage of Participants | ||
| Percentage of Participants With Overall Tumor Response (Response Rate) | Neuroblastoma (Metaiodobenzylguanidine Positive Evaluable) | 0 | Percentage of Participants | ||
| Percentage of Participants With Overall Tumor Response (Response Rate) | Ependymoma | 0 | Percentage of Participants | ||
| Percentage of Participants With Overall Tumor Response (Response Rate) | Medulloblastoma/Supratentorial Primitive Neuroectodermal Tumor | 0 | Percentage of Participants | ||
| Percentage of Participants With Overall Tumor Response (Response Rate) | Non-Brainstem High-Grade Glioma | 0 | Percentage of Participants | ||
| Number of Patients With Adverse Events, Discontinuations, or Deaths Possibly Due to Study Drug | Osteosarcoma | >=1 AdEERs possibly related to study drug | 3 | Participants | |
| Number of Patients With Adverse Events, Discontinuations, or Deaths Possibly Due to Study Drug | Ewing's Sarcoma/Peripheral Primitive Neuroectodermal Tumors | >=1 AdEERs possibly related to study drug | 2 | Participants |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Osteosarcoma | 10 | |
| Overall Study | STARTED | Ewing's Sarcoma/Peripheral Primitive Neuroectodermal Tumors | 11 | |
| Overall Study | STARTED | Rhabdomyosarcoma | 9 | |
| Overall Study | STARTED | Neuroblastoma (Measureable Disease) | 5 | |
| Overall Study | STARTED | Neuroblastoma (Metaiodobenzylguanidine Positive Evaluable) | 6 | |
| Overall Study | STARTED | Ependymoma | 10 | |
| Overall Study | STARTED | Medulloblastoma/Supratentorial Primitive Neuroectodermal Tumor | 11 | |
| Overall Study | STARTED | Non-Brainstem High-Grade Glioma | 10 | |
| Overall Study | COMPLETED | Osteosarcoma | 10 | |
| Overall Study | COMPLETED | Ewing's Sarcoma/Peripheral Primitive Neuroectodermal Tumors | 7 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events43
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Infection with normal ANC or Grade 1 | Blood and lymphatic system disorders | Pemetrexed | 2 | 72 | 2 |
| other | Dermatology/Skin - Other | Cardiac disorders | Pemetrexed | 1 | 72 | 1 |
| other | Pulmonary/Upper Respiratory - Other | Cardiac disorders | Pemetrexed | 1 | 72 | 1 |
| other | Thrombosis/thrombus/embolism | Cardiac disorders | Pemetrexed | 1 | 72 | 1 |
| other | Sodium, serum-low | Congenital, familial and genetic disorders | Pemetrexed | 1 | 72 | 1 |
| other | Diarrhea | Gastrointestinal disorders | Pemetrexed | 1 | 72 | 1 |
| other | Hemorrhage, GI: Rectum | Gastrointestinal disorders | Pemetrexed | 1 | 72 | 1 |
| other | Pain: Tumor pain | Gastrointestinal disorders | Pemetrexed | 1 | 72 | 1 |
| other | Fever | General disorders | Pemetrexed | 2 | 72 | 2 |
| other | Seizure | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Pemetrexed | 2 | 72 | 2 |
1 to 10 of 43Source ClinicalTrials.gov
See all 43 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pemetrexed | ||
| Total, other adverse events | Pemetrexed | 10 | 72 |
| Total, serious adverse events | Pemetrexed | 21 | 72 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00520936
GET https://conductscience.org/api/trials/v1/NCT00520936/results?page=2