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A Study of Pemetrexed in Children With Recurrent Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00520936
Recruitment Status : Completed
First Posted : August 27, 2007
Results First Posted : February 23, 2011
Last Update Posted : February 25, 2011
Sponsor:
Collaborator:
Children's Oncology Group
Information provided by:
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE August 24, 2007
First Posted Date  ICMJE August 27, 2007
Results First Submitted Date  ICMJE February 1, 2011
Results First Posted Date  ICMJE February 23, 2011
Last Update Posted Date February 25, 2011
Study Start Date  ICMJE September 2007
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 23, 2011)		 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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 24, 2007)
  • Response rate
  • Toxicity
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 1, 2011)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 24, 2007)
  • To examine the presence and relationship of pharmacogenomic markers to tumor response.
  • To examine the presence and relationship of pharmacogenomic markers to toxicity.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Pemetrexed in Children With Recurrent Cancer
Official Title  ICMJE A Phase II Study of Pemetrexed in Children With Recurrent Malignancies
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Osteosarcoma
  • Medulloblastoma
  • Sarcoma, Ewing's
  • Neuroblastoma (Measurable Disease)
  • Neuroblastoma (Metaiodobenzylguanidine
  • Positive Evaluable)
  • Rhabdomyosarcoma
  • Ependymoma
  • Non-brainstem High-grade Glioma
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Pemetrexed
Intervention: Drug: pemetrexed
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 1, 2011)		 72
Original Estimated Enrollment  ICMJE
 (submitted: August 24, 2007)		 160
Actual Study Completion Date  ICMJE February 2010
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 22 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00520936
Other Study ID Numbers  ICMJE 10294
H3E-MC-JMHW ( Other Identifier: Eli Lilly and Company )
ADVL0525 ( Other Identifier: Children's Oncology Group )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Chief Medical Officer, Eli Lilly
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Eli Lilly and Company
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Children's Oncology Group
Investigators  ICMJE
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
PRS Account Eli Lilly and Company
Verification Date February 2011

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