Glioma Clinical Trial
Official title:
A Randomized Open Label Phase II Trial of Aprepitant (Emend) in Combination With Ondansetron Compared to Standard 5HT3 Serotonin Antagonist (Ondansetron) in the Prevention of Acute and Delayed Chemotherapy Induced Nausea and Vomiting (CINV) in Glioma Patients Receiving a Temozolomide Based Regimen
Patients diagnosed with malignant glioma who are receiving temozolomide will be accrued in this open label, phase 2, randomized single institution trial of aprepitant in combination with ondansetron versus ondansetron alone for the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV). Sixty-eight (68) patients will be randomized to each arm of the study.
Sixty-eight (68) patients will be randomized to each arm of the study. Patient randomization
will be stratified by grade of tumor (1 or 2 versus 3 or 4) and the number of prior
progressions (0 or 1 versus 2). Within each of the 4 strata defined by these factors, a
permuted block randomization scheme will be used to assign patients to receive either
aprepitant in combination with ondansetron or ondansetron alone.
Though the study is comparative, the goal of the study is to determine whether aprepitant is
worthy of further investigation in this setting, and not to make definitive statements about
the comparative effectiveness of ondansetron treatment with or without aprepitant.
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