Study Treatment and Dose Escalation
DLTs
Helixor-M was administered intravenously on Monday, Wednesday, and Friday on a weekly basis. Four dose levels of mistletoe were evaluated: 150, 300, 600, and 900 mg. The dose frequency and starting and maximum dose levels were informed by the phase I trial of intravenous Helixor P (A traditional 3 + 3 method was employed, where dose escalation continued when at least 3 patients completed a safety evaluation at a given dose level with DLTs in fewer than a third of patients. The MTD was defined as the dose level immediately below the dose level at which 2 or more patients in a cohort (dose level) experienced a treatment-related DLT.