Phase II study of temozolomide in patients with relapsing high grade glioma and poor performance status

Temozolomide (SCHS2.365), an oral alkylating agent which penetrates the blo od-brain barrier, evolved as an alternative to dacarbazine. The aim of this study was to evaluate the efficacy and safety of temozolomide in terms of overall survival, progression-free survival, clinical benefit and health re lated quality of life in symptomatic patients with relapsing malignant glio ma and a poor performance status, Eleven patients were enrolled in the stud y, The median age was 44.6 years, Patients were treated with temozolomide p er os at a dose of 150-200 mg/m(2) daily for 5 consecutive days, Each cycle was repeated every 28 days. The median number of courses given per patient was 3.5. Nine patients were assessable for response, All patients were eva luable for toxicity. Based on radiographic findings 4 patients had stable d isease (2 patients after a total of 16 cycles, and 2 patients after a total of in cycles), Four patients had progressive disease after 2 to 4 cycles. Of these 3 patients demonstrated a clinical benefit and one patient died af ter 3 cycles of treatment, Six patients had a significant clinical benefit even after 2 cycles of treatment with improvement of their neurological and performance status. Hematologic toxicity Or II-III occurred in 3/9 patient s, Nonhematologic toxicity consisted of or I nausea, and vomiting, in concl usion temozolomide appears to be a useful alternative for patients with rel apsing malignant glioma after radiation and surgery and a poor performance status with little or no toxicity and considerable clinical benefit.