Approaches to improve the prognosis of patients with high-grade glioma, which is 
still grim despite combined therapy and major advances in the development of new 
drugs, are highly important. Chemotherapeutic agents have not consistently 
produced favorable results in the relapse setting so far, with tumor responses 
reported in a minority of cases. Among them, doxorubicin has not shown 
significant efficacy, despite being one of the most effective substances in 
vitro and in animal models. Nevertheless, encapsulation of doxorubicin using 
polyethylene-glycol significantly improves penetration across the blood-brain 
barrier. Moreover, recent clinical trials in other entities have demonstrated 
that similar clinical responses can be achieved using approximately half of the 
dose of polyethylene-glycol-liposomes compared with conventional liposomes. 
Considering these facts, polyethylene-glycol-liposomal doxorubicin with and 
without tamoxifen was evaluated within two sequential Phase II trials performed 
at our institution. Polyethylene-glycol-liposomal doxorubicin (Caelyx) was 
efficient in a reasonable number of patients with equivalent results in 
comparison with other successful Phase II studies. This article will discuss the 
literature and our own results on polyethylene-glycol-liposomal doxorubicin, 
with a special focus on toxicity and efficacy data raised in clinical trials on 
patients with high-grade glioma.