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Bevacizumab in Combination With Metronomic Temozolomide for Recurrent Malignant Glioma

This study has been completed.
Sponsor:
Collaborators:
Genentech
Schering-Plough
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00501891
First received: July 13, 2007
Last updated: March 11, 2013
Last verified: March 2013
History of Changes
Results First Received: February 6, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Glioblastoma Multiforme
Interventions: Drug: Bevacizumab
Drug: Metronomic Temozolomide

  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
Bevacizumab and Temozolomide Patients will receive up to 12 cycles of Avastin and temozolomide, and each cycle is 28 days. Avastin will be administered at 10 mg/kg every other week beginning a minimum of 7 days after a biopsy or 28 days after a craniotomy. Temozolomide will be dosed at 50 mg/m2 daily in a 28-day cycle.

Participant Flow:   Overall Study
    Bevacizumab and Temozolomide  
STARTED     32  
COMPLETED     32  
NOT COMPLETED     0  



  Baseline Characteristics
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Reporting Groups
  Description
Bevacizumab and Temozolomide Patients will receive up to 12 cycles of Avastin and temozolomide, and each cycle is 28 days. Avastin will be administered at 10 mg/kg every other week beginning a minimum of 7 days after a biopsy or 28 days after a craniotomy. Temozolomide will be dosed at 50 mg/m2 daily in a 28-day cycle.

Baseline Measures
    Bevacizumab and Temozolomide  
Number of Participants  
[units: participants]
 		  32  
Age  
[units: years]
Mean ± Standard Deviation 		  54.4  ± 12.8  
Gender  
[units: participants]
 		 
Female     13  
Male     19  



  Outcome Measures
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1.  Primary:   6-Month Progression-free Survival   [ Time Frame: 6 months ]
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2.  Secondary:   Response Rate   [ Time Frame: 27 months ]
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3.  Secondary:   Incidence and Severity of CNS Hemorrhage and Systemic Hemorrhage   [ Time Frame: 27 months ]
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4.  Secondary:   Incidence of Grade ≥ 4 Hematologic or Grade ≥ 3 Non-hematologic Toxicity   [ Time Frame: 27 months ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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
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Results Point of Contact:  
Name/Title: Annick Desjardins, MD
Organization: The Preston Robert Tisch Brain Tumor Center at Duke
phone: 919-684-6173
e-mail: annick.desjardins@duke.edu


Publications of Results:


Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00501891     History of Changes
Other Study ID Numbers: 00000404, AVF3821s, P04860
Study First Received: July 13, 2007
Results First Received: February 6, 2013
Last Updated: March 11, 2013
Health Authority: United States: Institutional Review Board