Phase I Study of Weekly Oral Miltefosine (Hexadecyl-Phosphocholine) in Cancer Patients

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Abstract
A clinical phase I trial with an oral formulation of miltefosine (MIL) was performed in patients with various advanced malignant diseases. The capsulated drug (50 mg or 100 mg capsules) was given once a week over a period of twelve hours with a starting dose of 100 mg (2x50 mg). Dose escalation proceeded up to 300 mg per week. At least three patients were treated at each dose level for eight weeks or until progressive disease or dose limiting toxicity occurred. 34 patients entered this study with 26 patients completing one eight-week course of therapy. Only gastrointestinal side effects were seen, namely nausea and vomiting or diarrhea up to grade III (WHO). Severity of these side effects was dose-related, but there was considerable individual variation. MTD was reached at the 300 mg dose level. Pharmacokinetic studies performed at this dose level showed peak plasma levels of approx. 15 nmol/ml and a plasma half life in excess of eight days after application on one single day. No objective remission has been seen in the patients of this study.

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