Convection-enhanced delivery (CED) of cintredekin besudotox (CB) was compared 
with Gliadel wafers (GW) in adult patients with glioblastoma multiforme (GBM) at 
first recurrence. Patients were randomized 2:1 to receive CB or GW. CB (0.5 
microg/mL; total flow rate 0.75 mL/h) was administered over 96 hours via 2-4 
intraparenchymal catheters placed after tumor resection. GW (3.85%/7.7 mg 
carmustine per wafer; maximum 8 wafers) were placed immediately after tumor 
resection. The primary endpoint was overall survival from the time of 
randomization. Prestated interim analyses were built into the study design. 
Secondary and tertiary endpoints were safety and health-related quality-of-life 
assessments. From March 2004 to December 2005, 296 patients were enrolled at 52 
centers. Demographic and baseline characteristics were balanced between the 2 
treatment arms. Median survival was 36.4 weeks (9.1 months) for CB and 35.3 
weeks (8.8 months) for GW (P = .476). For the efficacy evaluable population, the 
median survival was 45.3 weeks (11.3 months) for CB and 39.8 weeks (10 months) 
for GW (P = .310). The adverse-events profile was similar in both arms, except 
that pulmonary embolism was higher in the CB arm (8% vs 1%, P = .014). This is 
the first randomized phase III evaluation of an agent administered via CED and 
the first with an active comparator in GBM patients. There was no survival 
difference between CB administered via CED and GW. Drug distribution was not 
assessed and may be crucial for evaluating future CED-based therapeutics.