A PHASE-I CLINICAL-STUDY OF LOW-DOSE ORAL INTERFERON-ALPHA

Twenty-five patients with systemic malignancies or cutaneous disorders were treated with low dosages (1-16 IU/kg/day) of oral interferon-alp ha in a phase-I study. There were no grade-3 or -4 toxicities. No pati ent achieved a partial or complete response. One patient with renal ce ll carcinoma had prolonged disease stabilization lasting for 22 months . No significant changes in lymphocyte subsets including T4/T8 ratio, or serum immunoglobulins were observed. Subjective improvement in gene ral well-being was reported by three patients. Low dosages of interfer on-alpha administered orally do not appear to have any significant imm unomodulatory or antitumor activity.