Table 7.

Summary of Evaluability and Types of DLTs During Consolidation

Dose Level	Thiotepa Dose (mg/kg/day)	Eligible Patients	Number Evaluable for DLT	Number Inevaluable for DLT	Reason Inevaluable	Number of DLTs	DLT
-	Not assigned	11	0	11	No Consolidation No dose level**	-
0	5	11	11	0		0
1	6	13+	13	0		1	Toxic Death (Candida, ARDS) in CC3
2	7.2	11	10	1	Withdrawn by parent in CC1	1	Neurologic Grade 4 toxicity (CC3)
3	8.4	13+	13	0		3	1 Severe Diarrhea and Vomiting (CC1)
							1 Failure to complete 3 cycles; Prolonged pancytopenia (CC1)
							1 Failure to complete 3 cycles; prolonged low platelets (CC3)
4	10	14	11	3	1 PD in CC2, 2 withdrawn before CC3	2	1 Hepatic Veno-occlusive Disease (CC3)
							Toxic Death (fungal sepsis) in CC2
5	12	19	18	1	Died during CC2	3	Pulmonary toxicity Grade 4 (CC2)
							Pulmonary toxicity Grade 4 (CC2)
							Veno-occlusive Disease (CC2)
Total		92	76	16		10

^*One patient was inappropriately treated by the institution at this dose level, after thiotepa dose escalation to the next level had been activated.

^**There were 11 patients that did not proceed to Consolidation therapy and thus are not eligible for DLT evaluation (see text).