Bendamustine Hydrochloride in Treating Patients With Recurrent or Progressive Anaplastic Glioma
This phase II trial is studying how well bendamustine hydrochloride works in treating patients with recurrent or progressive anaplastic glioma or glioblastoma multiforme. Drugs used in chemotherapy, such as bendamustine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing
Adult Anaplastic Astrocytoma
Adult Anaplastic Oligodendroglioma
Recurrent Adult Brain Tumor
Drug: bendamustine hydrochloride
Procedure: quality-of-life assessment
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Bendamustine in the Treatment of Recurrent High-Grade Gliomas (Anaplastic Gliomas and Glioblastoma)|
- PFS [ Time Frame: At 6 months ] [ Designated as safety issue: No ]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.
- Best overall response [ Time Frame: Over 12 months ] [ Designated as safety issue: No ]
- PFS [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
- Toxicity that results in significant reduction in or cessation of bendamustine hydrochloride treatment [ Time Frame: Monthly ] [ Designated as safety issue: Yes ]
- Toxic death [ Time Frame: Monthly ] [ Designated as safety issue: Yes ]
- Survival [ Time Frame: Over 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||October 2008|
|Estimated Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
Experimental: Treatment (chemotherapy)
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:Procedure: quality-of-life assessment
Other Name: quality of life assessment
I. The primary endpoint for this study is the 6-month progression-free survival (PFS) (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 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 for 30 days and then every 3 months thereafter.
|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 Hutchinson Cancer Research Center/University of Washington Cancer Consortium|
|Seattle, Washington, United States, 19024-1024|
|Principal Investigator:||Marc Chamberlain||Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|