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Bendamustine Hydrochloride in Treating Patients With Recurrent or Progressive Anaplastic Glioma

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ClinicalTrials.gov Identifier: NCT00823797
Recruitment Status : Completed
First Posted : January 16, 2009
Results First Posted : May 19, 2017
Last Update Posted : July 7, 2017
Sponsor:
Collaborators:
National Cancer Institute (NCI)
National Comprehensive Cancer Network
Information provided by (Responsible Party):
Maciej Mrugala, University of Washington

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   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
Enrollment 45
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (Bendamustine Hydrochloride) for Anaplastic Glioma Treatment (Bendamustine Hydrochloride) for Glioblastoma
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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.

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.

Period Title: Overall Study
Started 29 16
Completed 29 16
Not Completed 0 0
Arm/Group Title Treatment (Bendamustine Hydrochloride) for Anaplastic Glioma Treatment (Bendamustine Hydrochloride) for Glioblastoma Total
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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.

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 of all reporting groups
Overall Number of Baseline Participants 29 16 45
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 16 participants 45 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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 16 participants 45 participants
Female
12
  41.4%
6
  37.5%
18
  40.0%
Male
17
  58.6%
10
  62.5%
27
  60.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 16 participants 45 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)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 16 participants 45 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  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 29 participants 16 participants 45 participants
29
 100.0%
16
 100.0%
45
 100.0%
1.Primary Outcome
Title PFS-6
Hide Description Defined as the proportion of patients who remain alive and free of any disease progression at 6 months. PFS over time will be estimated using the Kaplan-Meier method with standard errors estimated using Greenwood's formula.
Time Frame At 6 months
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Bendamustine Hydrochloride) for Glioblastoma Treatment (Bendamustine Hydrochloride) for Anaplastic Glioma
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 16 29
Measure Type: Count of Participants
Unit of Measure: Participants
1
   6.3%
8
  27.6%
2.Secondary Outcome
Title PFS
Hide Description Defined as the time from date of initial therapy to first objective documentation of tumor progression or death.
Time Frame Up to progression or death, whichever came first, assessed up to 108 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Bendamustine Hydrochloride) for Glioblastoma Treatment (Bendamustine Hydrochloride) for Anaplastic Glioma
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 16 29
Median (95% Confidence Interval)
Unit of Measure: months
1.0
(-0.5 to 2.6)
2.6
(-1.0 to 6.3)
3.Secondary Outcome
Title Toxic Death
Hide Description Defined as death that is possibly, probably, or definitely attributed to bendamustine hydrochloride.
Time Frame Up to 30 days after completion of study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Bendamustine Hydrochloride) for Glioblastoma Treatment (Bendamustine Hydrochloride) for Anaplastic Glioma
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 16 29
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
4.Secondary Outcome
Title Overall Survival
Hide Description *inclusive of subjects still alive at time of last reporting.
Time Frame Until death or last reported survival
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Bendamustine Hydrochloride) for Glioblastoma Treatment (Bendamustine Hydrochloride) for Anaplastic Glioma
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 16 29
Median (95% Confidence Interval)
Unit of Measure: months
18.3
(8.2 to 28.4)
45.6
(33.6 to 57.7)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Bendamustine Hydrochloride)
Hide Arm/Group Description

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.

Bendamustine Hydrochloride: Given IV

Quality-of-Life Assessment: Ancillary studies

All-Cause Mortality
Treatment (Bendamustine Hydrochloride)
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Bendamustine Hydrochloride)
Affected / at Risk (%) # Events
Total   3/45 (6.67%)    
Immune system disorders   
Allergic Reaction   1/45 (2.22%)  1
Respiratory, thoracic and mediastinal disorders   
Pneumonia   2/45 (4.44%)  2
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment (Bendamustine Hydrochloride)
Affected / at Risk (%) # Events
Total   45/45 (100.00%)    
Blood and lymphatic system disorders   
Lymphopenia   36/45 (80.00%) 
Thrombocytopenia   9/45 (20.00%) 
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Maciej Mrugala, MD, PhD, MPH
Organization: University of Washington
Phone: 206-543-4069
EMail: mmrugala@uw.edu
Layout table for additonal information
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 ( U.S. NIH Grant/Contract )
First Submitted: January 15, 2009
First Posted: January 16, 2009
Results First Submitted: April 7, 2017
Results First Posted: May 19, 2017
Last Update Posted: July 7, 2017