BALTIMORE, Md--The results of a phase III double-blind trial of Guilford Pharmaceutical Inc.'s Gliadel have been published in Lancet (April 22, 1995). In patients with malignant brain tumors, 6-month median survival rates increased from 23 weeks with placebo to 31 weeks with Gliadel treatment, the company said. For patients with glioblastoma multiforme, the increase was from 20 weeks to 28 weeks, a 55% improvement.
Gliadel is a biodegradable polymer wafer containing carmustine(Drug information on carmustine) in the polymer matrix. Up to eight wafers are implanted into the cavity created by tumor removal, thus overcoming the limitations of IV carmustine.
The trial, led by Henry Brem, MD, of Johns Hopkins, involved 222 patients at 27 centers.