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Phase II Imatinib + Hydroxyurea in Treatment of Patients With Recurrent/Progressive Grade II Low-Grade Glioma (LGG)

This study has been completed.
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00615927
First received: February 3, 2008
Last updated: March 13, 2013
Last verified: December 2012
Results First Received: December 31, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Glioblastoma
Gliosarcoma
Intervention: Drug: Imatinib Mesylate & Hydroxyurea

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Astrocytoma Grade II Astrocytoma
Oligodendroglioma Grade II Oligodendroglioma or oligoastrocytomas

Participant Flow:   Overall Study
    Astrocytoma   Oligodendroglioma
STARTED   32   32 
COMPLETED   32   32 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Astrocytoma Grade II Astrocytoma
Oligodendroglioma Grade II Oligodendroglioma or oligoastrocytomas
Total Total of all reporting groups

Baseline Measures
   Astrocytoma   Oligodendroglioma   Total 
Overall Participants Analyzed 
[Units: Participants]
 32   32   64 
Age 
[Units: Years]
Mean (Standard Deviation)
 42.6  (16.6)   46.6  (11.8)   44.6  (14.4) 
Gender 
[Units: Participants]
     
Female   12   13   25 
Male   20   19   39 


  Outcome Measures
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1.  Primary:   12-month Progression Free Survival (PFS)   [ Time Frame: 12 months ]

2.  Secondary:   Median Progression-free Survival   [ Time Frame: Time in weeks from the start of cycle 1 to the date of first progression according to modified Macdonald criteria or to death due to any cause, assessed up to 156 weeks ]

3.  Secondary:   Median Overall Survival (OS)   [ Time Frame: Time in weeks from the start of cycle 1 to date of death due to any cause, assessed up to 156 weeks ]

4.  Secondary:   Objective Response Rate   [ Time Frame: 156 weeks ]

5.  Secondary:   Safety and Tolerability of Gleevec + Hydroxyurea in Patients With Low-grade Gliomas   [ Time Frame: 156 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Annick Desjardins, MD, FRCPC
Organization: Duke University Medical Center
phone: 919-668-
e-mail: annick.desjardins@dm.duke.edu



Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00615927     History of Changes
Other Study ID Numbers: Pro00008799
Study First Received: February 3, 2008
Results First Received: December 31, 2012
Last Updated: March 13, 2013
Health Authority: United States: Institutional Review Board