Neoplasms

All Conditions

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Rare Diseases

Sarcoma

Recurrence

Glioma

Osteosarcoma

Medulloblastoma

Neuroblastoma

Sarcoma, Ewing

Ependymoma

Rhabdomyosarcoma

Neuroectodermal Tumors, Primitive, Peripheral

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Neuroepithelial

Neoplasms, Germ Cell and Embryonal

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neoplasms, Bone Tissue

Neoplasms, Connective Tissue

Myosarcoma

Soft Tissue Sarcoma

Ewing Sarcoma

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Pemetrexed

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Folinic Acid

Folate

Vitamin B9

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

pemetrexed

1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

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.

A Study of Pemetrexed in Children With Recurrent Cancer

A Phase II Study of Pemetrexed in Children With Recurrent Malignancies

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.

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.

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.

Children's Oncology Group

Eli Lilly and Company

Chief Medical Officer

Pemetrexed 1910 mg/m2 (or 60 mg/kg if patient \<12 months old)

Pemetrexed 1910 milligrams per meters squared (mg/m\^2) (or 60 milligrams per kilogram \[mg/kg\] if patient \<12 months old)

Pemetrexed 1910 mg/m\^2 (or 60 mg/kg if patient \<12 months old)

Ewing's Sarcoma/Peripheral Primitive Neuroectodermal Tumors

Neuroblastoma (Measureable Disease)

Neuroblastoma (Metaiodobenzylguanidine Positive Evaluable)

Medulloblastoma/Supratentorial Primitive Neuroectodermal Tumor

Non-Brainstem High-Grade Glioma

Total

Age Continuous

Sex: Female, Male

American Indian or Alaska Native

Asian

Black or African American

White

Other

Unknown

Race/Ethnicity, Customized

United States

Canada

Region of Enrollment

Missing

Classifies patients according to their functional impairment. Scores range from 0-100, the lower the score, the worse the survival for most serious illnesses.

100 - Normal no complaints; no evidence of disease 90 - Normal activity; minor signs of disease 80 - Activity with effort; some signs of disease 70 - Unable to carry on normal activity \<=60 Needs increasing assistance up to Death (0)

Karnofsky Performance Score

100=fully active, normal. 90=minor restrictions in physically strenuous activity. 80=active, but tires more quickly. 70=both greater restriction of and less time spent in play activity. 60=up and around, but minimal active play; keeps busy with quieter activities. 50=gets dressed, but lies around much of the day; no active play, able to participate in all quiet play activities. 40=mostly in bed; participates in quiet activities. 30=in bed; needs assistance even for quiet play. 20=often sleeping; play entirely limited to very passive activities. 10=No play; does not get out of bed.

Lansky Play Score

Percentage of Participants With Overall Tumor Response (Response Rate)

>=1 AdEERs possibly related to study drug

Discontinued due to AE possibly related to drug

Died on therapy possibly related to study drug

Died within 31 days of last dose of drug PRSD

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

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.

Pharmacogenomics - Measure the Response of Genes Related to Toxicity

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of Pemetrexed in Children With Recurrent Cancer	NCT00520936	Osteosarcoma Medulloblastoma Sarcoma, Ewing'... Neuroblastoma (... Neuroblastoma (... Positive Evalua... Rhabdomyosarcom... Ependymoma Non-brainstem H...	pemetrexed	- 22 Years	Eli Lilly and Company
A Study of Pemetrexed in Children With Recurrent Cancer	NCT00520936	Osteosarcoma Medulloblastoma Sarcoma, Ewing'... Neuroblastoma (... Neuroblastoma (... Positive Evalua... Rhabdomyosarcom... Ependymoma Non-brainstem H...	pemetrexed	- 22 Years	Eli Lilly and Company

Spots Global Cancer Trial Database for positive evaluable)