Table 1.

Eligibility status and characteristics of all patients in the study

	Dose level, No. (%)
Eligibility status or characteristic	250 mg N = 4	500 mg N = 12	250 mg BID N = 12
Histologically proven primary supra-tentorial glioma amenable to Temozolomide treatment	4 (100)	12 (100)	12 (100)
WHO Histologic Grade
Grade 3	2 (50.0)	3 (25.0)	4 (33.3)
Grade 4	2 (50.0)	6 (50.0)	6 (50)
Grade 3 transformed to Grade 4		3 (25.0)	2 (16.7)
Status of disease
First recurrence	3 (75.0)	9 (75.0)	10 (83.3)
Second recurrence	0 (0)	2 (16.7)	1 (8.3)
Newly diagnosed not amenable to radiotherapy	1 (25.0)	1 (8.3)	1 (8.3)
Prior Surgery
No	3 (75.0)	2 (16.7)	0 (0.0)
Yes for primary brain tumor	1 (25.0)	9 (75.0)	9 (75.0)
Yes for recurrence	0 (0.0)	0 (0.0)	1 (8.3)
Yes for both	0 (0.0)	1 (8.3)	2 (16.7)
Prior radiotherapy
No	1 (25.0)	1 (8.3)	3 (25.0)
Yes	3 (75.0)	11 (91.7)	9 (75.0)
Prior chemotherapy
No	2 (50.0)	6 (50.0)	4 (33.3)
Yes, adjuvant	2 (50.0)	6 (50.0)	7 (58.3)
Yes for first recurrence	0 (0.0)	0 (0.0)	1 (8.3)
Sex
Male	3 (75.0)	10 (83.3)	7 (58.3)
Female	1 (25.0)	2 (16.7)	5 (41.7)
Age
Median	65.8	52.3	51.4
Range	33.7–70.8	22.5–65.8	27.7–66.3
Performance status (ECOG)
0	1 (25.0)	7 (58.3)	7 (58.3)
1	3 (75.0)	4 (33.3)	4 (33.3)
2	0 (0.0)	1 (8.3)	1 (8.3)

Abbreviations: BID, twice daily; ECOG, Eastern Cooperative Oncology Group; WHO, World Health Organization.