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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
Results First Received: February 1, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Osteosarcoma
Medulloblastoma
Sarcoma, Ewing's
Neuroblastoma (Measurable Disease)
Neuroblastoma (Metaiodobenzylguanidine
Positive Evaluable)
Rhabdomyosarcoma
Ependymoma
Non-brainstem High-grade Glioma
Intervention: Drug: pemetrexed

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Osteosarcoma Pemetrexed 1910 milligrams per meters squared (mg/m^2) (or 60 milligrams per kilogram [mg/kg] if patient <12 months old)
Ewing's Sarcoma/Peripheral Primitive Neuroectodermal Tumors Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
Rhabdomyosarcoma Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
Neuroblastoma (Measureable Disease) Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
Neuroblastoma (Metaiodobenzylguanidine Positive Evaluable) Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
Ependymoma Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
Medulloblastoma/Supratentorial Primitive Neuroectodermal Tumor Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
Non-Brainstem High-Grade Glioma Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)

Participant Flow:   Overall Study
    Osteosarcoma     Ewing's Sarcoma/Peripheral Primitive Neuroectodermal Tumors     Rhabdomyosarcoma     Neuroblastoma (Measureable Disease)     Neuroblastoma (Metaiodobenzylguanidine Positive Evaluable)     Ependymoma     Medulloblastoma/Supratentorial Primitive Neuroectodermal Tumor     Non-Brainstem High-Grade Glioma  
STARTED     10 [1]   11     9     5     6     10     11     10  
COMPLETED     10 [2]   7     7     5     5     10     7     9  
NOT COMPLETED     0     4     2     0     1     0     4     1  
Physician Decision                 0                 2                 1                 0                 0                 0                 0                 0  
Withdrawal by Subject                 0                 0                 0                 0                 0                 0                 0                 1  
Toxicity Requiring Removal from Study                 0                 1                 0                 0                 0                 0                 2                 0  
Death                 0                 0                 0                 0                 0                 0                 1                 0  
Protocol Violation                 0                 1                 1                 0                 1                 0                 1                 0  
[1] 75 participants entered the study and 72 were enrolled and received study drug.
[2] Study completion defined as treated until disease progression. Completed=progressive disease.



  Baseline Characteristics
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Reporting Groups
  Description
Osteosarcoma Pemetrexed 1910 milligrams per meters squared (mg/m^2) (or 60 milligrams per kilogram [mg/kg] if patient <12 months old)
Ewing's Sarcoma/Peripheral Primitive Neuroectodermal Tumors Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
Rhabdomyosarcoma Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
Neuroblastoma (Measureable Disease) Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
Neuroblastoma (Metaiodobenzylguanidine Positive Evaluable) Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
Ependymoma Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
Medulloblastoma/Supratentorial Primitive Neuroectodermal Tumor Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
Non-Brainstem High-Grade Glioma Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
Total Total of all reporting groups

Baseline Measures
    Osteosarcoma     Ewing's Sarcoma/Peripheral Primitive Neuroectodermal Tumors     Rhabdomyosarcoma     Neuroblastoma (Measureable Disease)     Neuroblastoma (Metaiodobenzylguanidine Positive Evaluable)     Ependymoma     Medulloblastoma/Supratentorial Primitive Neuroectodermal Tumor     Non-Brainstem High-Grade Glioma     Total  
Number of Participants  
[units: participants]
 		  10     11     9     5     6     10     11     10     72  
Age  
[units: years]
Mean ± Standard Deviation 		  14.94  ± 4.28     18.24  ± 3.35     8.74  ± 4.96     6.23  ± 2.98     9.62  ± 5.38     8.42  ± 4.59     12.00  ± 7.13     12.75  ± 5.15     11.96  ± 5.97  
Gender  
[units: participants]
 		                 
Female     4     8     6     1     1     3     4     5     32  
Male     6     3     3     4     5     7     7     5     40  
Race/Ethnicity, Customized  
[units: Participants]
 		                 
American Indian or Alaska Native     0     0     2     0     0     0     0     0     2  
Asian     0     1     0     0     0     0     0     1     2  
Black or African American     4     0     0     2     1     1     3     3     14  
White     4     8     7     2     4     9     8     6     48  
Other     1     1     0     1     0     0     0     0     3  
Unknown     1     1     0     0     1     0     0     0     3  
Region of Enrollment  
[units: participants]
 		                 
United States     7     7     8     5     5     9     10     10     61  
Canada     3     4     1     0     1     1     1     0     11  
Karnofsky Performance Score [1]
[units: Participants]
 		                 
100     0     2     0     0     0     1     0     0     3  
90     3     3     0     0     1     0     1     1     9  
80     0     1     0     0     0     0     0     1     2  
70     0     1     0     0     0     0     1     0     2  
50     1     0     0     0     0     0     1     0     2  
Missing     6     4     9     5     5     9     8     8     54  
Lansky Play Score [2]
[units: Participants]
 		                 
100     1     1     3     4     2     2     2     3     18  
90     1     3     3     1     1     2     3     4     18  
80     2     0     2     0     2     3     2     0     11  
70     0     0     0     0     0     1     0     1     2  
60     1     0     1     0     0     1     1     0     4  
50     1     0     0     0     0     0     0     0     1  
Missing     4     7     0     0     1     1     3     2     18  
[1]

Classifies patients according to their functional impairment. Scores range from 0-100, the lower the score, the worse the survival for most serious illnesses.

100 - Normal no complaints; no evidence of disease 90 - Normal activity; minor signs of disease 80 - Activity with effort; some signs of disease 70 - Unable to carry on normal activity <=60 Needs increasing assistance up to Death (0)
[2] 100=fully active, normal. 90=minor restrictions in physically strenuous activity. 80=active, but tires more quickly. 70=both greater restriction of and less time spent in play activity. 60=up and around, but minimal active play; keeps busy with quieter activities. 50=gets dressed, but lies around much of the day; no active play, able to participate in all quiet play activities. 40=mostly in bed; participates in quiet activities. 30=in bed; needs assistance even for quiet play. 20=often sleeping; play entirely limited to very passive activities. 10=No play; does not get out of bed.



  Outcome Measures
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1.  Primary:   Percentage of Participants With Overall Tumor Response (Response Rate)   [ Time Frame: baseline to measured progressive disease (up to 1 year) ]
  Show Outcome Measure 1

2.  Secondary:   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) ]
  Show Outcome Measure 2

3.  Secondary:   Pharmacogenomics - Measure the Response of Genes Related to Toxicity   [ Time Frame: baseline ]
  Show Outcome Measure 3


  Serious Adverse Events
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  Other Adverse Events
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Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   1%  

Reporting Groups
  Description
Pemetrexed Pemetrexed 1910 mg/m2 (or 60 mg/kg if patient <12 months old)

Other Adverse Events
    Pemetrexed  
Total, other (not including serious) adverse events    
# participants affected / at risk     10/72  
Blood and lymphatic system disorders    
Infection with normal ANC or Grade 1 † 1  
# participants affected / at risk     2/72 (2.78%)  
# events     2  
Cardiac disorders    
Dermatology/Skin - Other † 2  
# participants affected / at risk     1/72 (1.39%)  
# events     1  
Pulmonary/Upper Respiratory - Other † 3  
# participants affected / at risk     1/72 (1.39%)  
# events     1  
Thrombosis/thrombus/embolism † 3  
# participants affected / at risk     1/72 (1.39%)  
# events     1  
Congenital, familial and genetic disorders    
Sodium, serum-low † 2  
# participants affected / at risk     1/72 (1.39%)  
# events     1  
Gastrointestinal disorders    
Diarrhea † 3  
# participants affected / at risk     1/72 (1.39%)  
# events     1  
Hemorrhage, GI: Rectum † 3  
# participants affected / at risk     1/72 (1.39%)  
# events     1  
Pain: Tumor pain † 1  
# participants affected / at risk     1/72 (1.39%)  
# events     1  
General disorders    
Fever † 3  
# participants affected / at risk     2/72 (2.78%)  
# events     2  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)    
Seizure † 2  
# participants affected / at risk     2/72 (2.78%)  
# events     2  
Renal and urinary disorders    
Hemorrhage, GU: Urinary NOS † 3  
# participants affected / at risk     1/72 (1.39%)  
# events     1  
Renal failure † 3  
# participants affected / at risk     1/72 (1.39%)  
# events     1  
Respiratory, thoracic and mediastinal disorders    
Hypoxia † 3  
# participants affected / at risk     2/72 (2.78%)  
# events     2  
† Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 12.0
2 Term from vocabulary, MedDRA 11.0
3 Term from vocabulary, MedDRA 13.0



  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979


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