A Study of Pemetrexed in Children With Recurrent Cancer
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ClinicalTrials.gov Identifier: NCT00520936 |
Recruitment Status
:
Completed
First Posted
: August 27, 2007
Results First Posted
: February 23, 2011
Last Update Posted
: February 25, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Osteosarcoma Medulloblastoma Sarcoma, Ewing's Neuroblastoma (Measurable Disease) Neuroblastoma (Metaiodobenzylguanidine Positive Evaluable) Rhabdomyosarcoma Ependymoma Non-brainstem High-grade Glioma | Drug: pemetrexed | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 72 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase II Study of Pemetrexed in Children With Recurrent Malignancies |
Study Start Date : | September 2007 |
Actual Primary Completion Date : | February 2010 |
Actual Study Completion Date : | February 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: Pemetrexed |
Drug: pemetrexed
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
Other Names:
|
- Percentage of Participants With Overall Tumor Response (Response Rate) [ Time Frame: 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.
- 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) ]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.
- Pharmacogenomics - Measure the Response of Genes Related to Toxicity [ Time Frame: 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | up to 22 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00520936
United States, California | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
Arcadia, California, United States, 91066 |
Study Director: | 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) | Eli Lilly and Company |
Additional Information:
Responsible Party: | Chief Medical Officer, Eli Lilly |
ClinicalTrials.gov Identifier: | NCT00520936 History of Changes |
Obsolete Identifiers: | NCT00459147, NCT00739427 |
Other Study ID Numbers: |
10294 H3E-MC-JMHW ( Other Identifier: Eli Lilly and Company ) ADVL0525 ( Other Identifier: Children's Oncology Group ) |
First Posted: | August 27, 2007 Key Record Dates |
Results First Posted: | February 23, 2011 |
Last Update Posted: | February 25, 2011 |
Last Verified: | February 2011 |
Additional relevant MeSH terms:
Neuroblastoma Osteosarcoma Rhabdomyosarcoma Ependymoma Medulloblastoma Sarcoma, Ewing Neuroectodermal Tumors, Primitive, Peripheral Neuroectodermal Tumors, Primitive Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms, Nerve Tissue Neoplasms, Bone Tissue Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Sarcoma Myosarcoma Neoplasms, Muscle Tissue Glioma Pemetrexed Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |