Table 1.

Dose escalation design^a

Dose Level	Number of CD-NSCs intracerebrally administered on day 1 of each cycleb	Oral 5-FC (mg/kg) taken every 6 hours on days 4–10 of each cycle	Oral leucovorin (mg) taken every 6 hours on days 4–10 of each cycle	Number of evaluable participants	DLTsc
1	50 x 106	37.5	---	3	0
2	100 x 106	37.5	---	3	0
3	150 x 106	37.5	---	3	0
4	150 x 106	37.5	25	6d	1

^aThis study implemented a standard 3+3 design for the treatment regimen of CD-NSCs with 5-FC (and concomitant leucovorin for dose level 4 participants).

^bThe length of each cycle was 14 days.

^cDLT – dose limiting toxicity.

^dSeven participants started treatment on dose level 4, but one was unevaluable and had to be replaced after receiving the first dose of CD-NSCs due to the tip of the Rickham catheter migrating into the lateral ventricle.