A phase I-II trial of the combination of recombinant leukocyte a interferon and recombinant human interferon-γ in patients with metastatic malignant melanoma

Abstract
Twenty patients with advanced malignant melanoma received daily intramuscular recombinant leukocyte A interferon (rIFN‐αA, Roferon‐A, Hoffmann‐Laroche, Nutley, NJ) concomitant with recombinant human interferon‐γ (rIFN‐γ Genentech, South San Francisco, CA). During the first week or dose was 2 × 106 U/m2 and the γ dose was 0.01 mg/m2 with escalations, if clinically tolerable, during the second week to 5 × 106 U/m2 and 0.025 mg/m2, respectively. Twelve patients received the escalated doses; subsequent granulocytopenia and a flu‐type illness were severe in four of the 12. We observed one partial response of MRI‐documented and biopsy‐confirmed osseous metastases for 7+ months. For all study participants, the median time to progression was 1 month with a median survival of 6 months. From the dose and schedule which we utilized, concurrent rIFN‐αA and rIFN‐γ provided little impact on advanced malignant melanoma.