Bendamustine Hydrochloride in Treating Patients With Recurrent or Progressive Anaplastic Glioma
|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|
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Bendamustine in the Treatment of Recurrent High-Grade Gliomas (Anaplastic Gliomas and Glioblastoma)|
- 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 ]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.
|Study Start Date:||October 2008|
|Estimated Study Completion Date:||December 2019|
|Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
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 Names:Other: Quality-of-Life Assessment
Other Name: Quality of Life Assessment
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|