| 악성종양환자에서 재조합 감마인터페론 ( LBD - 001 ) 의 제 1 상 임상실험 |
| 김노경, 방영주, 허대석, 김흥태, 김효진, 박근칠, 강윤구, 신동복, 이명철, 김병국, 신상구, 박성회, 조한익 |
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| Phase 1 Trial of Recombinant Interferon Gamma ( LBD - 001 ) in Cancer Patients |
| Noe Kyeong Kim, Yung Jue Bang, Dae Seog Heo, Heung Tae Kim, Hyo Jin Kim, Keun Chil Park, Keun Chil Park, Dong Bok Shin, Myung Chul Lee, Byoung Kook Kim, Sang Goo Shin, Seong Hoe Park, Han Ik Cho |
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| ABSTRACT |
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A phase I study of recombinant gamma-interferon (LBD-001) was conducted in 23 patients with advanced malignancy. The schedule was the intramuscular administration of recombinant interferon-gamma 6 consecutive days a week for 2 weeks followed by 2 weeks of rest and was repeated every 28 days. Patients were assigned to six dose levels. The maximum tolerated dose was 10.0x10(6) units/m/day and the major toxicities were flulike symptoms. After intramuscular injection, the pharmacological data fit the single compartmental modeL More than 2/3 of the dose administered was absorbed. The absorbance T 1/2 was longer with values of 247.6 minutes but interferon-gamma was cleared with a short half life of 49.9 minutes from the circulation. Antitumor effects occurred in patients with chronic myelogenous leukemia and malignant melanoma. |
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