Gliadel, XRT, Temodar, Avastin Followed by Avastin, Temodar for Newly Diagnosed Glioblastoma Multiforme (GBM)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Genentech, Inc.
Eisai Inc.
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01186406
First received: August 19, 2010
Last updated: October 17, 2014
Last verified: October 2014
Results First Received: October 17, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Glioblastoma Multiforme
Gliosarcoma
Interventions: Drug: Gliadel
Radiation: Radiation Therapy
Drug: Avastin
Drug: Temodar

  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
Study recruitment was stopped early due to unacceptable toxicity after 41 participants were enrolled.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Forty-seven subjects were consented to the study. Six subjects were screen failures and were not enrolled.

Reporting Groups
  Description
Gliadel, Radiation Therapy, Avastin, Temodar

Single arm study where patients with newly diagnosed Grade IV malignant glioma will receive Gliadel at the time of resection, followed by radiation therapy (XRT), Avastin, and Temodar for approximately 6 1/2 weeks, followed by Avastin and Temodar post-radiation

Gliadel, Radiation Therapy, Avastin, Temodar: Patients will have 1-8 wafers of Gliadel inserted at the time of surgical resection. At a minimum of four weeks, but not greater than eight weeks post-craniotomy, they will be treated with standard radiation therapy, and daily Temodar (75mg/m2) for 6.5 weeks of radiation. In addition, Avastin (10 mg/kg) will be given every 14 days, and will begin a minimum of 42 days post-operatively.

Beginning 2-3 weeks after the last radiation therapy, but not greater than 8 weeks, patients will be treated with Avastin (10 mg/kg) every 14 days along with 5 day Temodar (200 mg/ m2).


Participant Flow:   Overall Study
    Gliadel, Radiation Therapy, Avastin, Temodar  
STARTED     41  
COMPLETED     41  
NOT COMPLETED     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
Gliadel, Radiation Therapy, Avastin, Temodar Single arm study where patients with newly diagnosed Grade IV malignant glioma will receive Gliadel at the time of resection, followed by radiation therapy (XRT), Avastin, and Temodar for approximately 6 1/2 weeks, followed by Avastin and Temodar post-radiation Patients will have 1-8 wafers of Gliadel inserted at the time of surgical resection. At a minimum of four weeks, but not greater than eight weeks post-craniotomy, subjects will be treated with standard radiation therapy. Avastin (10 mg/kg) will be given every 14 days, and will begin a minimum of 42 days post-operatively. Beginning two to three weeks after the last radiation therapy, but not greater than eight weeks, subjects will be treated with Avastin (10mg/m2) every 14 days. At a minimum of four weeks, but not greater than eight weeks post-craniotomy, subjects will be treated with standard radiation therapy and daily Temodar (75mg/m2) for 6.5 weeks of the radiation.

Baseline Measures
    Gliadel, Radiation Therapy, Avastin, Temodar  
Number of Participants  
[units: participants]
  41  
Age  
[units: years]
Mean ± Standard Deviation
  57.2  ± 10.7  
Gender  
[units: participants]
 
Female     13  
Male     28  



  Outcome Measures
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1.  Primary:   21-month Overall Survival   [ Time Frame: 21 months ]

2.  Secondary:   Median Overall Survival   [ Time Frame: 21 months ]

3.  Secondary:   Median Progression-free Survival   [ Time Frame: 21 months ]

4.  Secondary:   Unacceptable Toxicity Related to the Treatment Regimen   [ Time Frame: 27 months ]


  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: 9196846173
e-mail: annick.desjardins@duke.edu


No publications provided


Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01186406     History of Changes
Other Study ID Numbers: Pro00025180
Study First Received: August 19, 2010
Results First Received: October 17, 2014
Last Updated: October 17, 2014
Health Authority: United States: Institutional Review Board