In an effort to improve survival in patients with high-grade brain tum
ours, it was hypothesised that local delivery of carmustine (BCNU) to
these tumours would prolong survival. By implanting a polymer impregna
ted with carmustine into the tumour resection cavity, it was hoped tha
t high local drug concentrations could be achieved over a sustained ti
me period with minimal systemic concentrations or toxicity. This hypot
hesis was tested in the laboratory, and the use of a carmustine polyme
r was found to be safe and efficacious in a rodent brain tumour model.
Based on the preclinical laboratory studies, a series of clinical stu
dies were carried out to evaluate the safety and efficacy of this trea
tment. Two phase III randomised, placebo-controlled studies have been
completed evaluating the use of a carmustine polymer in patients at th
e time of recurrence and as initial therapy. Both studies demonstrated
that carmustine polymers resulted in prolonged survival. These studie
s establish the principle that local delivery by a polymer is an effic
acious drug delivery strategy. Furthermore, these studies demonstrate
that local delivery of carmustine by the polymer is an effective treat
ment for patients with high-grade gliomas.