Table 2.

Planned and evaluated dose levels of vorinostat and 131I-MIBG

Dose level131I-MIBG (mCi/kg)Vorinostat (mg/m2/dose)Number enteredNumber evaluable for DLTNumber evaluable with DLT
18180530
212180430
312230330
415230761 a
518230222 b
5a18180660
618270NA (not opened)NANA

NOTE: Dose level 6 was the planned highest dose level, but exceeded the MTD level and was therefore never evaluated.

  • aGrade 4 hypokalemia.

  • bGrade 3 oral bleeding with delayed platelet engraftment (n = 1) and grade 5 CNS hemorrhage and grade 3 QT prolongation (n = 1).