Phase I study of recombinant leukocyte a interferon (IFN-α2A, roferon-A) with doxorubicin in advanced malignant disease

Abstract

Twenty-six patients with advanced cancer received monthly intramuscular recombinant leukocyte A interferon (IFN-α2A), 12 × 10⁶ U/m² daily × 5 with escalating doses of doxorubicin, 25 to 40 mg/m² on day 3. As anticipated, dose-limiting toxicities were an influenza-type syndrome and myelosuppression. A clinically meaningful and dramatic partial response of hepatocellular carcinoma persisted for 11.5 months associated with an α-fetoprotein reduction from 39,000 to 299 ng/ml. For Phase II investigations, the authors recommend the above IFN-α2A dose with doxorubicin, 40 mg/m², in patients with a performance score of 0 or 1 and no prior chemotherapy or significant radiation therapy which would enhance myelo-suppression.