Adult Glioblastoma Clinical Trial
Official title:
A Phase II Study of Bendamustine in the Treatment of Recurrent High-Grade Gliomas (Anaplastic Gliomas and Glioblastoma)
This phase II trial studies how well bendamustine hydrochloride works in treating patients with anaplastic glioma or glioblastoma that has come back (recurrent) or growing, spreading or getting worse (progressive). 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.
PRIMARY OBJECTIVES:
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.
SECONDARY OBJECTIVES:
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).
OUTLINE:
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.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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