Bendamustine Hydrochloride in Treating Patients With Recurrent or Progressive Anaplastic Glioma
Adult Anaplastic Astrocytoma
Adult Anaplastic Oligodendroglioma
Adult Giant Cell Glioblastoma
Recurrent Adult Brain Tumor
Drug: bendamustine hydrochloride
Other: 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: Up to 12 months ] [ Designated as safety issue: No ]
- PFS [ Time Frame: At 6 months ] [ Designated as safety issue: No ]Defined as the time from date of initial therapy to first objective documentation of tumor progression or death. PFS over time will be estimated using the Kaplan-Meier method with standard errors estimated using Greenwood's formula.
- Toxicity that results in significant reduction in or cessation of bendamustine hydrochloride treatment [ Time Frame: Up to 30 days after completion of study treatment ] [ Designated as safety issue: Yes ]All reported adverse events will be coded using the Cancer Therapy Evaluation Program Common Toxicity Criteria. The number and percent of subjects reporting adverse events (all, severe or worse, serious and related) will be quantified.
- Toxic death [ Time Frame: Up to 30 days after completion of study treatment ] [ Designated as safety issue: Yes ]Defined as death that is possibly, probably, or definitely attributed to bendamustine hydrochloride.
- Quality of life, assessed by the FACT-BR total score [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]FACT-BR total score trajectories will be examined for each patient, and for groups defined by length of follow-up. Quality of life data will be used to quantify the impact of adverse events on patient quality of life.
|Study Start Date:||October 2008|
|Estimated Primary Completion Date:||February 2016 (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|
|Northwestern University||Active, not recruiting|
|Chicago, Illinois, United States, 60611|
|United States, Utah|
|Huntsman Cancer Institute/University of Utah||Active, not recruiting|
|Salt Lake City, Utah, United States, 84112|
|United States, Washington|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Recruiting|
|Seattle, Washington, United States, 98109|
|Contact: Waldie Ashley 206-288-6365 email@example.com|
|Principal Investigator: Marc C. Chamberlain|
|Principal Investigator:||Marc Chamberlain||Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|