title: Initial clinical trial of the macrophage activator muramyl tripeptide-phosphatidylethanolamine encapsulated in liposomes in patients with advanced cancer.
abstract: A phase I clinical trial of the macrophage activator, muramyl tripeptide-phosphatidylethanolamine has been carried out in 37 patients (47 courses) at doses of 0.01-6.0 mg/m2 intravenously twice weekly for 4 weeks. Activation of peripheral blood monocytes and drug toxicity were used as the parameters to monitor the trial. Toxicity was acute systemic responses of fever, chills, and hypertension without a clear dose response. No major organ-related toxicity was seen. A dose of 4.0 mg/m2 biweekly produced activation of blood monocytes; a dose of 6.0 mg/m2 produced inhibition. There was one complete response of 3 months duration in a patient with renal cell carcinoma with pulmonary metastases. The optimum dose for phase II studies is in the range of 1-4 mg/m2 twice weekly for 4 weeks, a dose that is well tolerated.
authors: Department of Medicine, Roswell Park Memorial Institute, Buffalo, NY 14263.
authors: P J
authors: PJ
authors: Creaven
authors: J W
authors: JW
authors: Cowens
authors: D E
authors: DE
authors: Brenner
authors: B M
authors: BM
authors: Dadey
authors: T
authors: T
authors: Han
authors: R
authors: R
authors: Huben
authors: C
authors: C
authors: Karakousis
authors: H
authors: H
authors: Frost
authors: D
authors: D
authors: LeSher
authors: J
authors: J
authors: Hanagan
mesh_terms: D000119:Acetylmuramyl-Alanyl-Isoglutamine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000293:Adolescent; D000328:Adult; D000368:Aged; D004337:Drug Carriers; D004341:Drug Evaluation; D005260:Female; D006801:Humans; D008081:Liposomes; D008262:Macrophage Activation / Q000187:drug effects*; D008297:Male; D008875:Middle Aged; D015394:Molecular Structure; D009369:Neoplasms / Q000188:drug therapy*; D010714:Phosphatidylethanolamines / Q000008:administration & dosage* / Q000009:adverse effects; D012720:Severity of Illness Index
chemical_list: D004337:Drug Carriers; D008081:Liposomes; D010714:Phosphatidylethanolamines; C037144:mifamurtide; D000119:Acetylmuramyl-Alanyl-Isoglutamine