Phase I study of weekly high-dose human lymphoblastoid interferon.
Interferon has been shown to have antineoplastic activity but an optimal dose schedule has not been defined. In this phase I study 12 patients with advanced cancer were treated with weekly high-dose human lymphoblastoid interferon given by 3-hour iv infusion to assess toxicity. The median maximum tolerated dose was 55 X 10(6) units/m2 and the dose-limiting toxicity was a complex of fever, fatigue, myalgias, anorexia, and weakness. Neither myelosuppression nor hepatotoxicity was encountered. One patient with metastatic melanoma achieved complete remission, which has been maintained for 2 years. Weekly high-dose iv infusion of interferon has antineoplastic activity, did not cause myelosuppression or hepatotoxicity, and was well-tolerated up to doses of 40-50 X 10(6) units/m2. Future trials should start at 30 X 10(6) units/m2 and should escalate by 10 X 10(6) units/m2/week to patient tolerance.
D000328:Adult; D000368:Aged; D004334:Drug Administration Schedule; D004341:Drug Evaluation; D005260:Female; D006801:Humans; D007263:Infusions, Parenteral; D007370:Interferon Type I / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D008207:Lymphatic Metastasis; D008297:Male; D008545:Melanoma / Q000188:drug therapy / Q000556:secondary; D008875:Middle Aged; D009369:Neoplasms / Q000628:therapy*
D007370:Interferon Type I