CLINICAL TRIALS WITH INTERFERON IN JAPAN NLM AIDSLINE Important note: Information in this article was accurate in 1989. The state of the art may have changed since the publication date.

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CLINICAL TRIALS WITH INTERFERON IN JAPAN

The Interferon System. A Current Review to 1987. Baron S et al, eds. The University of Texas Medical Branch Series in Biomedical Science, Austin, TX, University of Texas Press, p. 461-7, 1987.. Unique Identifier : AIDSLINE ICDB/89650514
Imanishi J; Kishida T; Dept. of Microbiology, Kyoto Prefectural Univ. of Medicine,; Kawaramachi-Hirokoji, Kamikyo-ku, Kyoto 602, Japan

Abstract: Clinical trials with interferon (IFN) in Japan are characterized by many companies joining in the trials and the use of all types of IFN: natural and recombinant (r) human (H) IFN-alpha, -beta, and -gamma. Natural HuIFN-alpha and -beta are each administered mainly at doses of 3-10 million IU; rHuIFN-alpha A, mainly at 3-20 million IU. HuIFN-alpha is mainly administered im; HuIFN-beta, mainly iv, since no or low IFN activity is detected in patients' (pts) sera when im injection is used. For viral infection of the eye, the IFN was dropped onto the eyes. For tumors, warts, or viral infection in skin, intralesional injection is used. For brain tumor, the IFN was injected locally via Ommaya reservoir into the dead space created by resection. For hepatoma, the IFN is administered by continuous ia infusion. When HuIFN-beta is injected iv at 12 million IU, IFN activity is detected in the serum immediately and reaches its peak within half an hr; when HuIFN-alpha is injected im at 100 million IU, the peak of IFN activity in the serum is detected 4.68 hr later. Side effects are listed in a table. Based on the data presented, it was concluded that HuIFN-alpha and -beta are effective against brain tumors, especially glioblastoma, medulloblastoma, and other gliomas; HuIFN-alpha has a partial effect on neuroblastoma in Stage III and no effect in Stage IV. Similarly, data indicate that HuIFN-beta is effective against common and juvenile warts and against metastatic malignant melanoma and metastatic carcinoma of the skin; that HuIFN-alpha is somewhat effective against renal cell carcinoma (complete remission in 2.9% of 136 cases; partial remission, in 16.2%); that HuIFN-alpha induces complete remission in pts with adult T-cell leukemia, partial remission in 16.7% of pts with multiple myeloma, and partial remission in 15.4% of pts with non-Hodgkin's lymphomas. In general, malignant tumors of the gastrointestinal tract and gynecologic organs are not sensitive to HuIFN; over 110 pts so treated showed no response. The efficacy rate was low (3% of 80 pts) for HuIFN treatment of bone and soft tissue cancers, and head and neck cancer did not respond to IFN therapy. For hepatitis B virus infections, HuIFN-alpha and -beta are useful, although their effects are partial and transient. For adenovirus-induced epidemic keratoconjunctivitis, HuIFN-beta showed a 93.3% efficacy, not significantly different from the 88.0% shown by iododeoxyuridine. Phase I and II studies of rHuIFN-gamma are ongoing; clinical effects are not yet reported. The pharmacokinetics of HuIFN-gamma were almost the same as those of HuIFN-alpha or -beta; side effects also were similar. (17 Refs)
Keywords: Brain Neoplasms/THERAPY Clinical Trials Drug Evaluation Glioma/THERAPY Hepatitis B/THERAPY Human Interferon Alfa, Recombinant/ADVERSE EFFECTS/THERAPEUTIC USE Interferon Type I/ADVERSE EFFECTS/THERAPEUTIC USE Interferon Type II/ADVERSE EFFECTS/THERAPEUTIC USE Interferon-gamma, Recombinant/ADVERSE EFFECTS/THERAPEUTIC USE Interferons/ADVERSE EFFECTS/*THERAPEUTIC USE Japan Keratitis, Dendritic/THERAPY Leukemia, T-Cell, Acute/THERAPY Melanoma/THERAPY Neoplasms/*THERAPY Skin Neoplasms/THERAPY Urogenital Neoplasms/THERAPY Warts/THERAPY CLINICAL TRIAL MONOGRAPH REVIEW REVIEW, TUTORIAL


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Copyright © 1989 - National Library of Medicine. Reproduced under license with the National Library of Medicine, Bethesda, MD.

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