A Study of Pemetrexed in Children With Recurrent Cancer - Full Text View

Sponsor:	Eli Lilly and Company
Collaborator:	Children's Oncology Group
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00520936

Purpose

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	Intervention	Phase
Osteosarcoma Medulloblastoma Sarcoma, Ewing's Neuroblastoma (Measurable Disease) Neuroblastoma (Metaiodobenzylguanidine Positive Evaluable) Rhabdomyosarcoma Ependymoma Non-brainstem High-grade Glioma	Drug: pemetrexed	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase II Study of Pemetrexed in Children With Recurrent Malignancies

Resource links provided by NLM:

Genetics Home Reference related topics: neuroblastoma

MedlinePlus related topics: Cancer Neuroblastoma Soft Tissue Sarcoma

Drug Information available for: Pemetrexed Pemetrexed disodium

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Percentage of Participants With Overall Tumor Response (Response Rate) [ Time Frame: baseline to measured progressive disease (up to 1 year) ] [ Designated as safety issue: No ]
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:

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) ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]
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.

Enrollment:	72
Study Start Date:	September 2007
Study Completion Date:	February 2010
Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	up to 22 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00520936

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

Additional Information:

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier:	NCT00520936 History of Changes
Obsolete Identifiers:	NCT00459147
Other Study ID Numbers:	10294, H3E-MC-JMHW, ADVL0525
Study First Received:	August 24, 2007
Results First Received:	February 1, 2011
Last Updated:	February 23, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Ependymoma
Glioma
Medulloblastoma
Neuroblastoma
Osteosarcoma
Rhabdomyosarcoma
Sarcoma, Ewing's
Sarcoma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

Neuroectodermal Tumors, Primitive
Neuroectodermal Tumors, Primitive, Peripheral
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Myosarcoma
Neoplasms, Muscle Tissue
Pemetrexed
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Antimetabolites, Antineoplastic

ClinicalTrials.gov processed this record on February 09, 2012