Abstract

A phase II clinical study of a human leukocyte interferon-α preparation (FPI-31) was performed in the patients with malignant tumors of skin.
In 20 patients with mycosis fungoides (MF), FPI-31 injected intramuscularly, 13 patients responded.
FPI-31 was also injected into the tumor tissue, and the following result was obtained.
All 3 patients with MF responded; in 2 patients with metastatic malignant melanoma, responder was one; in 7 patients with Bowen's disease, responder was 6; all 2 patients with solar keratosis responded.
The main adverse reactions were fever, anorexia and increased serum GPT. However, they were mild and transient.
These results suggested usefulness of FPI-31 in the treatment of patients with malignant tumors of skin, particularly MF.