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A Study of Pemetrexed in Children With Recurrent Cancer

This study has been completed.
Sponsor:
Collaborator:
Children's Oncology Group
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00520936
First received: August 24, 2007
Last updated: February 23, 2011
Last verified: February 2011
History of Changes

August 24, 2007
February 23, 2011
September 2007
February 2010   (final data collection date for primary outcome measure)
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.
  • Response rate
  • Toxicity
Complete list of historical versions of study NCT00520936 on ClinicalTrials.gov Archive Site
  • 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.
  • To examine the presence and relationship of pharmacogenomic markers to tumor response.
  • To examine the presence and relationship of pharmacogenomic markers to toxicity.
Not Provided
Not Provided
 
A Study of Pemetrexed in Children With Recurrent Cancer
A Phase II Study of Pemetrexed in Children With Recurrent Malignancies

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.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Osteosarcoma
  • Medulloblastoma
  • Sarcoma, Ewing's
  • Neuroblastoma (Measurable Disease)
  • Neuroblastoma (Metaiodobenzylguanidine
  • Positive Evaluable)
  • Rhabdomyosarcoma
  • Ependymoma
  • Non-brainstem High-grade Glioma
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
Experimental: Pemetrexed
Intervention: Drug: pemetrexed
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
February 2010
February 2010   (final data collection date for primary outcome measure)

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
Both
up to 22 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00520936
10294, H3E-MC-JMHW, ADVL0525
Yes
Chief Medical Officer, Eli Lilly
Eli Lilly and Company
Children's Oncology Group
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
Eli Lilly and Company
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP