Phase I study of recombinant human interferon beta in patients with advanced cancer.

Twenty-two patients with advanced cancer were entered into a phase I study of recombinant human interferon beta (IFN-beta). The maximum tolerated dose was 100 X 10(6) IU administered intravenously on a three times weekly schedule, and persistent fever was the dose-limiting toxicity. The majority of patients tolerated administration of IFN-beta well with negligible hematologic toxicity. Details of the clinical effects of escalating doses of recombinant human IFN-beta, administered three times weekly, are described.