Table 1.

Patient characteristics and outcome summary

	Patient Group				All Eligible Patients n = 65
	Eligible Phase I Patients^ n = 12^		Eligible Phase II Patients^ n = 53^
	n	%	n	%	n	%
Age, y, at Study Enrollment
Median	6.3	–	6.6	–	6.6	–
Range	2.2–15.8	–	2.5–12.9	–	2.2–15.8	–
Sex	4	33.3	33	62.3	37	56.9
Female
Male	8	66.7	20	37.7	28	43.1
Race	8	66.7	32	60.4	40	61.5
White, Non-Hispanic
Black	1	8.3	11	20.8	12	18.5
Unknown	1	8.3	7	13.2	8	12.3
Native American	1	8.3	1	1.9	2	3.1
Asian	1	8.3	1	1.9	2	3.1
Pacific Islander	0	0	1	1.9	1	1.5
Ethnicity	8	66.7	39	73.6	47	72.3
Non-Hispanic
Hispanic or Latino	3	25.0	7	13.2	10	15.4
Unknown	1	8.3	7	13.2	8	12.3
Diagnosis	10	83.3	49	92.5	59	90.8
Brainstem glioma
Astrocytoma, anaplastic	1	8.3	2	3.8	3	4.6
Glioblastoma, NOS	0	0	2	3.8	2	3.1
Fibrillary astrocytoma	1	8.3	0	0	1	1.5
# of Maintenance Courses	1	8.3	12	22.6	13	20.0
0
1	2	16.7	8	15.1	10	15.4
2	2	16.7	5	9.4	7	10.8
3	2	16.7	8	15.1	10	15.4
4	2	16.7	11	20.8	13	20.0
5	1	8.3	3	5.7	4	6.2
6	0	0	1	1.9	1	1.5
7	1	8.3	2	3.8	3	4.6
9	0	0	1	1.9	1	1.5
10	0	0	1	1.9	1	1.5
13	1	8.3	1	1.9	2	3.1
# of Maintenance Courses
0	1	8.3	12	22.6	13	20.0
≥1	11	91.7	41	77.4	52	80.0
Median (for patients with ≥1 course)	3	–	3	–	3	–
Range (for patients with ≥1 course)	1–13	–	1–13	–	1–13	–
Best Response	0	0	3	5.7	3	4.6
No response assessment
PR	0	0	7	13.2	7	10.8
SD	11	91.7	38	71.7	49	75.4
PD	1	8.3	5	9.4	6	9.2

^ The 6 patients treated at the MTD as part of the phase I study are included in this table as phase II patients.