title: [Large scale production of natural lymphokines with antitumor activity (OH-1) using transplantable human cell lines and its clinical use].
abstract: OH-1, consisting of purified natural human TNF-alpha and natural human IFN-alpha induced from BALL-1 cells stimulated with HVJ, has been obtained in large scale using Hayashibara's hamster method and has synergistically enhanced antitumor activity against wider spectrum of tumor cells, in vitro and in vivo. One of the action mechanism of OH-1 is clarified to be a result of arrest in the S phase of the cell cycle. In phase I study of OH-1 by intravenous administration to 23 patients with different advanced and/or metastatic malignant tumors, OH-1 shows the similar side effects to that of IFN-alpha without serious ones. The maximum tolerant dose is assumed as over 2,000 x 10(4) U/body. The early phase II clinical study of OH-1 is now on going, in which OH-1 shows anti-tumor effect with intravenous administration of over 200 x 10(4) U/body/day. As a preliminary result, OH-1 in dose of over 200 x 10(4) U/body/day to 62 patients with disseminated or advanced solid tumor shows an efficacy rate of 21.0%; CR in one patient of breast cancer and PR in three patients each of breast cancer, hepatocellular carcinoma and renal-cell carcinoma and PR in three other advanced cancer.
authors.affiliation: First Department of Surgery, Okayama University Medical School.
authors.forename: K
authors.initials: K
authors.lastname: Orita
mesh_terms: D000818:Animals; D000970:Antineoplastic Agents; D002460:Cell Line; D006224:Cricetinae; D004338:Drug Combinations; D004357:Drug Synergism; D006801:Humans; D007370:Interferon Type I / Q000008:administration & dosage / Q000096:biosynthesis* / Q000627:therapeutic use; D009369:Neoplasms / Q000628:therapy*; D014407:Tumor Cells, Cultured; D014409:Tumor Necrosis Factor-alpha / Q000008:administration & dosage / Q000096:biosynthesis* / Q000627:therapeutic use
chemical_list: D000970:Antineoplastic Agents; D004338:Drug Combinations; D007370:Interferon Type I; D014409:Tumor Necrosis Factor-alpha