PURPOSE: The chemotherapeutic agent temozolomide (TMZ) and the antiangiogenic 
agent thalidomide have both demonstrated antitumor activity in patients with 
recurrent malignant glioma. The objectives of this study were to determine if 
the combined strategy of these oral agents with radiation therapy (RT) is 
associated with an improved median survival of patients with newly diagnosed 
glioblastoma multiforme and to evaluate toxicity.
METHODS AND MATERIALS: Sixty-seven patients were enrolled in this trial. 
Radiotherapy parameters were a total dose of 60 Gy delivered in 2 Gy fractions 
over 6 weeks. Temozolomide was administered starting the first day of RT at 150 
mg/m(2) daily for 5 days every 4 weeks for the first cycle and escalated to a 
maximum dose of 200 mg/m(2). Thalidomide was started on Day 7 of RT at 200 mg 
and escalated by 100-200 mg every 1-2 weeks depending on patient tolerance, to a 
maximum of 1,200 mg daily.
RESULTS: Sixty-one patients have progressed, with a median time to progression 
of 22 weeks. Fifty-six patients have died, and the median survival was 73 weeks.
CONCLUSIONS: This strategy of combination TMZ, thalid and RT was relatively well 
tolerated with favorable survival outcome for patients with GM when compared to 
patients not treated with adjuvant chemotherapy and similar to those who have 
received nitrosourea adjuvant chemotherapy. It is unclear the added advantage 
thalid has in combination with TMZ for this patient population.