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-alpha in a phase-I study. There were no grade-3 or -4 toxicities. No patients achieved a partial or complete response. One patient with renal cell 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 general well-being was reported by three patients. Low dosages of interferon-alpha administered orally do not appear to have any significant immunomodulatory or antitumor activity.
Department of Medical Oncology, University of Texas M.D. Anderson Cancer Center, Houston.
K
K
Dhingra
M
M
Duvic
S
S
Hymes
P
P
McLaughlin
J
J
Rothberg
J U
JU
Gutterman
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D016516:CD4-CD8 Ratio; D004361:Drug Tolerance; D005260:Female; D006801:Humans; D007136:Immunoglobulins / Q000097:blood; D007167:Immunotherapy; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage* / Q000009:adverse effects; D016131:Lymphocyte Subsets / Q000276:immunology; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000276:immunology / Q000628:therapy*; D011994:Recombinant Proteins; D012871:Skin Diseases / Q000276:immunology / Q000628:therapy*
D007136:Immunoglobulins; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins