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Title   ¾Ç¼º Á¾¾ç ȯÀÚ¿¡¼­ ÀçÁ¶ÇÕ °¨¸¶ ÀÎÅÍÆä·Ð ( LBD - 001 ) ÀÇ Á¦ 2 »ó ÀÓ»ó½ÇÇè ( Phase 2 Trial of Recombinant Interferon - Gamma ( LBD - 001 ) in Patients with Malignancies )
Publicationinfo   1992 Jan; 024(04): 549-562.
Key_word   Interferon-gamma, Immunotherapy, Renal cell carcinoma, Malignant melanoma, Chronic myelogenous leukemia
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Abstract   Metastatic rena1 cell carcinoma, malignant melanoma and chronic myelogenous leukemia are resistant to the conventional cytotoxic anticancer chemotherpay. Therefore there have been many therapeutic trials of immunotherapy for these diseases. Alpha-interferon was widely used and resulted in the response rate of 10 to 20%. Gamma-interferon has been expected to have more potent antitumor effect theoretically and better efficacy clinically. We conducted a phase II study of recombinant interferon-gamma(LBD-OOI, produced by Lucky, Co.) in patients with metastatic renal cell carcinoma or malignant melanoma or Phila- delphia-chromosome positive chronic myelogenous leukemia from Feb. 1989 to Dec. 1991. The schedule was the intramuscular administration of recombinant interferon-gamma 10x 10(6)u/m(2) /day six consecutive days a week for two weeks followed by two weeks of rest and was repeated every four weeks. In renal cell carcinoma, 4 in 26 patients had partial remission(response rate 15.4%) and their remission duration was 20, 23, 56, 78+ weeks respectively. Time to proaression was 4 to 90+ weeks(median 17 weeks). In malignant melanoma, one out of 20 patients had partial remission and its remission duration was 28 weeks. Time to progression was 2 to 57 weeks(median 6 weeks). In chronic myelogenous leukemia, 2 out of 14 patients(l4.2%) had hematological partial remission and their remission duration was 6 and 124' weeks. Cytogenetically, there were l(7.1%) camplete remission, 3(21.4%) partial remission and 3(21.4%) minimal response. As side effects, fever occured freque#ntly but managesble with antipyretics and hepatotoxicity and neu- tropenia were tolerable. We concluded that recombinant interferon-gamma
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