An Eastern Cooperative Oncology Group phase I-II pilot study of polyriboinosinic-polyribocytidylic acid poly-L-lysine complex in patients with metastatic malignant melanoma.
Sixteen patients with metastatic malignant melanoma were treated with poly(I,C)-LC 5 mg/m2 twice weekly by intravenous injection. No antitumor responses occurred. Fever (frequently greater than 40 degrees C) and fatigue were dose limiting toxicities. One patient developed a fever of 42.2 degrees C when poly(I,C)-LC was given on 2 consecutive days. Interferon was consistently detected in the serum 8 h after a single injection of poly(I,C)-LC (median titer 199 U/ml). No enhancement of interferon induction was detected on the second day when poly(I,C)-LC was given on 2 consecutive days.
M J
MJ
Hawkins
M
M
Levin
E C
EC
Borden
D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000627:therapeutic use / Q000633:toxicity; D002266:Carboxymethylcellulose Sodium / Q000008:administration & dosage / Q000627:therapeutic use* / Q000633:toxicity / Q000031:analogs & derivatives; D004341:Drug Evaluation; D005221:Fatigue / Q000139:chemically induced; D005260:Female; D005334:Fever / Q000139:chemically induced; D006801:Humans; D007372:Interferons / Q000097:blood; D008297:Male; D008545:Melanoma / Q000188:drug therapy* / Q000276:immunology / Q000556:secondary; D008747:Methylcellulose / Q000031:analogs & derivatives*; D008875:Middle Aged; 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
D000970:Antineoplastic Agents; D011107:Polylysine; C019531:poly ICLC; D008747:Methylcellulose; D007372:Interferons; D002266:Carboxymethylcellulose Sodium; D011070:Poly I-C