Objective. This report describes the development and clinical use of a dacarbazine ambulatory infusion for palliative treatment of metastatic malignant mela noma.
Case Summary. A 39-year-old male with meta static malignant melanoma received ambulatory infu sion of dacarbazine, 2.5 mg/kg/d X 10 days (courses 1 and 2) and 5 mg/kg/d X 10 days (course 3). This was made possible by the development of a modified dacarbazine infusion formulation which increased drug stability. The first two courses were well toler ated and the patient remained independent and ac tive. A pilot pharmacokinetic study was undertaken on the third course to enable comparison of the potential exposure of tissues to dacarbazine between the prolonged infusion and conventional schedules.
Discussion. Under conditions replicating ambu latory infusion (37°C) the modified infusion of dacar bazine was stable for 24 hours (92.4% remaining) compared with a standard infusion in water for injection (89.2% remaining after 8 hours). The patient appeared to benefit from ambulatory treatment, and mild nausea was the only adverse effect recorded during the first two treatment courses. The pharma cokinetic study revealed an average steady-state plasma concentration (Cpssave ) and AUC of 243 ng · mL-1 and 58.4 μg · h·mL -1, respectively.
Conclusion. Ambulatory infusion of dacarba zine in the home setting is possible with the modified infusion formulation described in this report.
