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Bendamustine Hydrochloride in Treating Patients With Recurrent or Progressive Anaplastic Glioma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
National Cancer Institute (NCI)
National Comprehensive Cancer Network
Information provided by (Responsible Party):
Maciej Mrugala, University of Washington
ClinicalTrials.gov Identifier:
NCT00823797
First received: January 15, 2009
Last updated: April 7, 2017
Last verified: April 2017
Results First Received: April 7, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Treatment
Conditions: Adult Anaplastic Astrocytoma
Adult Anaplastic Oligodendroglioma
Adult Giant Cell Glioblastoma
Adult Glioblastoma
Adult Gliosarcoma
Recurrent Adult Brain Neoplasm
Interventions: Drug: Bendamustine Hydrochloride
Other: Quality-of-Life Assessment

  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
Treatment (Bendamustine Hydrochloride) for Anaplastic Glioma

Anaplastic Glioma Arm

Patients receive bendamustine hydrochloride IV over 30-90 minutes on days 1-2. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.

Treatment (Bendamustine Hydrochloride) for Glioblastoma

Glioblastoma Arm

Patients receive bendamustine hydrochloride IV over 30-90 minutes on days 1-2. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.


Participant Flow:   Overall Study
    Treatment (Bendamustine Hydrochloride) for Anaplastic Glioma   Treatment (Bendamustine Hydrochloride) for Glioblastoma
STARTED   29   16 
COMPLETED   29   16 
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.
No text entered.

Reporting Groups
  Description
Treatment (Bendamustine Hydrochloride) for Anaplastic Glioma

Anaplastic Glioma Arm

Patients receive bendamustine hydrochloride IV over 30-90 minutes on days 1-2. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.

Treatment (Bendamustine Hydrochloride) for Glioblastoma

Glioblastoma Arm

Patients receive bendamustine hydrochloride IV over 30-90 minutes on days 1-2. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.

Total Total of all reporting groups

Baseline Measures
   Treatment (Bendamustine Hydrochloride) for Anaplastic Glioma   Treatment (Bendamustine Hydrochloride) for Glioblastoma   Total 
Overall Participants Analyzed 
[Units: Participants]
 29   16   45 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      28  96.6%      13  81.3%      41  91.1% 
>=65 years      1   3.4%      3  18.8%      4   8.9% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      12  41.4%      6  37.5%      18  40.0% 
Male      17  58.6%      10  62.5%      27  60.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      1   3.4%      0   0.0%      1   2.2% 
Not Hispanic or Latino      28  96.6%      16 100.0%      44  97.8% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      1   3.4%      0   0.0%      1   2.2% 
Asian      1   3.4%      1   6.3%      2   4.4% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      1   3.4%      0   0.0%      1   2.2% 
White      26  89.7%      14  87.5%      40  88.9% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      1   6.3%      1   2.2% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   29   16   45 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   PFS-6   [ Time Frame: At 6 months ]

2.  Secondary:   PFS   [ Time Frame: Up to progression or death ]

3.  Secondary:   Toxic Death   [ Time Frame: Up to 30 days after completion of study treatment ]

4.  Secondary:   Overall Survival   [ Time Frame: Until death or last reported survival ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Maciej Mrugala, MD, PhD, MPH
Organization: University of Washington
phone: 206-543-4069
e-mail: mmrugala@uw.edu



Responsible Party: Maciej Mrugala, University of Washington
ClinicalTrials.gov Identifier: NCT00823797     History of Changes
Other Study ID Numbers: 6803
NCI-2010-00714 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
6803 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
P30CA015704 ( US NIH Grant/Contract Award Number )
Study First Received: January 15, 2009
Results First Received: April 7, 2017
Last Updated: April 7, 2017