A phase I evaluation of poly(I,C)-LC in cancer patients.
Twenty-five patients with metastatic carcinoma were entered into a Phase I clinical trial using poly(I,C)-LC at either 1 mg/m2 or 4 mg/m2 intravenous, twice weekly, for 4 weeks. None of the 15 patients entered at the 1 mg/m2 dose had an objective response; three had progressive disease. Similarly, no objective responses were observed among the 10 patients treated at the 4 mg/m2 dose of poly(I,C)-LC; one patient was removed from the study due to progressive disease. Toxicities observed at the 1 mg/m2 dose were mild hypotension, fever, nausea, vomiting, fatigue, and headache. The first patient treated at the 4 mg/m2 dose was taken off of the study for severe hypotension. In the subsequent nine patients treated at this dose, a pretreatment with one dose at 1 mg/m2 was given, and no further problems with hypotension were encountered. The other toxicities at 4 mg/m2 were similar to those seen at 1 mg/m2.
H C
HC
Stevenson
P G
PG
Abrams
C S
CS
Schoenberger
R B
RB
Smalley
R B
RB
Herberman
K A
KA
Foon
D002266:Carboxymethylcellulose Sodium / Q000008:administration & dosage / Q000627:therapeutic use* / Q000633:toxicity / Q000031:analogs & derivatives; D004341:Drug Evaluation; D005334:Fever / Q000139:chemically induced; D006801:Humans; D007022:Hypotension / Q000139:chemically induced; D007372:Interferons / Q000097:blood; D007700:Kinetics; D008747:Methylcellulose / Q000031:analogs & derivatives*; D009325:Nausea / Q000139:chemically induced; D009369:Neoplasms / Q000188:drug therapy* / Q000276:immunology; D011070:Poly I-C / Q000008:administration & dosage / Q000627:therapeutic use* / Q000633:toxicity; D011107:Polylysine / Q000008:administration & dosage / Q000627:therapeutic use* / Q000633:toxicity / Q000031:analogs & derivatives
D011107:Polylysine; C019531:poly ICLC; D008747:Methylcellulose; D007372:Interferons; D002266:Carboxymethylcellulose Sodium; D011070:Poly I-C