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
|Condition or disease||Intervention/treatment||Phase|
|Adult Anaplastic Astrocytoma Adult Anaplastic Oligodendroglioma Adult Giant Cell Glioblastoma Adult Glioblastoma Adult Gliosarcoma Recurrent Adult Brain Neoplasm||Drug: Bendamustine Hydrochloride Other: Quality-of-Life Assessment||Phase 2|
I. The primary endpoint for this study is the 6-month progression-free survival-i.e., the proportion of patients who remain alive and free of any tumor progression at 6 months.
I. To determine the safety of single agent bendamustine (Treanda) (bendamustine hydrochloride) the treatment of malignant gliomas.
II. To determine the efficacy of bendamustine (Treanda) as a single agent as assessed by progression-free survival (PFS) at 6 months.
III. To assess quality of life using the Functional Assessment of Cancer Therapy-Brain (FACT-BR).
Patients receive bendamustine hydrochloride intravenously (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.
After completion of study treatment, patients are followed up at 30 days and then every 2 months for up to 3 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Bendamustine in the Treatment of Recurrent High-Grade Gliomas (Anaplastic Gliomas and Glioblastoma)|
|Study Start Date :||October 2008|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||April 2017|
Experimental: Treatment (bendamustine hydrochloride)
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.
Drug: Bendamustine Hydrochloride
Other: Quality-of-Life Assessment
Other Name: Quality of Life Assessment
- PFS-6 [ Time Frame: At 6 months ]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.
- PFS [ Time Frame: Up to progression or death, whichever came first, assessed up to 108 months ]Defined as the time from date of initial therapy to first objective documentation of tumor progression or death.
- Toxic Death [ Time Frame: Up to 30 days after completion of study treatment ]Defined as death that is possibly, probably, or definitely attributed to bendamustine hydrochloride.
- Overall Survival [ Time Frame: Until death or last reported survival ]*inclusive of subjects still alive at time of last reporting.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00823797
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|United States, Utah|
|Huntsman Cancer Institute/University of Utah|
|Salt Lake City, Utah, United States, 84112|
|United States, Washington|
|Fred Hutch/University of Washington Cancer Consortium|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||Maciej Mrugala||Fred Hutch/University of Washington Cancer Consortium|