A Study of Pemetrexed in Children With Recurrent Cancer

Study Description

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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.

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 Design

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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

Arms and Interventions

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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: LY 231514; Alimta

Outcome Measures

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Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.
2. 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.

Eligibility Criteria

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Ages Eligible for Study:	up to 22 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Locations

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

Sponsors and Collaborators

Eli Lilly and Company

Children's Oncology Group

Investigators

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Lilly Clinical Trial Registry 

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
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