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.