Study of Liposome Encapsulated Mitoxantrone (LEM) in Patients With Advanced Cancer
Status:
Completed
Trial end date:
2004-06-01
Target enrollment:
Participant gender:
Summary
Liposome entrapped mitoxantrone (LEM) is a mixture of commercially available mitoxantrone HCL
(Novantrone) and a combination of lyophilized lipids. Mitoxantrone, the active agent in the
investigational formulation, is a currently marketed chemotherapeutic agent. The rationale
for development of liposomal formulations is primarily that of improving the safety profile
of the drug, which may permit dose intensification and/or an increase in the cumulative dose
that may be administered, resulting in enhanced efficacy.
LEM will be given to patients with advanced solid tumors to determine the dose of drug these
patients can tolerate. Patients will receive intravenous LEM every 21 days until the disease
progresses or toxicity occurs requiring treatment discontinuation. Anti-tumor effects of LEM
will be assessed and patients will be evaluated for safety and tolerability.