methylcellulose and Fever

Topics: Adolescent; Adult; Aged; Carboxymethylcellulose Sodium; Child; Child, Preschool; Clinical Trials as Topic; Drug Evaluation; Female; Fever; Humans; Hypotension; Infant; Interferons; Leukemia; Male; Methylcellulose; Middle Aged; Neoplasms; Peptides; Poly I-C; Polylysine

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.

Topics: Carboxymethylcellulose Sodium; Drug Evaluation; Fever; Humans; Hypotension; Interferons; Kinetics; Methylcellulose; Nausea; Neoplasms; Poly I-C; Polylysine

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.

Topics: Adult; Aged; Antineoplastic Agents; Carboxymethylcellulose Sodium; Drug Evaluation; Fatigue; Female; Fever; Humans; Interferons; Male; Melanoma; Methylcellulose; Middle Aged; Poly I-C; Polylysine

The ability of polyriboinosionic acid [poly(rI)].polyribocytidylic acid [poly(rC)], mismatched analog poly (rI).poly[r(C12Uracil)n], and poly(rI).poly(rC) complexed with poly L-lysine and carboxymethylcellulose [poly(ICLc)] to induce interferon and the comparative toxicity of each in cats were evaluated. Each induced high levels of circulating interferon, although poly(ICLC) injected intravenously at 1 to 4 mg/kg induced up to 10 times more interferon than the other compounds. Each compound was pyrogenic and caused a transient decrease in leukocyte numbers. Poly(rI).poly(rC) and the mismatched analog caused severe diarrhea and nausea at the highest drug concentrations (1 to 4 mg/kg), but poly (ICLC) did not. Each compound also caused depression and lethargy and impaired coordination.

Topics: Animals; Carboxymethylcellulose Sodium; Cats; Dose-Response Relationship, Drug; Female; Fever; Interferon Inducers; Interferons; Leukocyte Count; Male; Methylcellulose; Peptides; Poly C; Poly I; Poly I-C; Polylysine; Polyribonucleotides; Time Factors