Phase II trials of recombinant leukocyte A interferon in disseminated malignant melanoma: results in 96 patients.
Ninety-six patients with advanced malignant melanoma received thrice weekly im recombinant leukocyte A interferon (Roferon-A) in three consecutive phase II trials utilizing doses of 12 X 10(6) U/m2, 50 X 10(6) U/m2, and 50 X 10(6) U/m2 plus cimetidine. The overall response rate was 22%, with median times to disease progression and survival of 3.9 and 11.3 months, respectively. For all study participants, the median times to disease progression and survival were 1.5 and 5 months, respectively. Most regressions occurred within the first month of treatment and were predominantly in soft tissue, although three patients are responding 2-3 years after onset of treatment. The most noteworthy toxic effects included a flu-type illness, anorexia, and fever (38.3-39.4 degrees C). The median weight loss was 2.1 kg on the low-dose regimen and 5.6 kg on the high-dose program. Recombinant leukocyte A interferon in the dosages and schedule that we used has definite but limited efficacy for patients with disseminated malignant melanoma.
D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D002927:Cimetidine / Q000008:administration & dosage; D002986:Clinical Trials as Topic; D004274:DNA, Recombinant; D004334:Drug Administration Schedule; D004341:Drug Evaluation; D005260:Female; D006801:Humans; D007370:Interferon Type I / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008545:Melanoma / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D008875:Middle Aged; D009279:Naphthacenes / Q000378:metabolism; D013997:Time Factors
D004274:DNA, Recombinant; D007370:Interferon Type I; D009279:Naphthacenes; C049327:7-deoxyadriamycinol aglycone; D002927:Cimetidine; C049326:7-deoxyadriamycin aglycone