PHASE-I-II STUDY OF LOW-DOSE INTRAVENOUS OKT3 AND SUBCUTANEOUS INTERLEUKIN-2 IN METASTATIC CANCER
PHASE-I-II STUDY OF LOW-DOSE INTRAVENOUS OKT3 AND SUBCUTANEOUS INTERLEUKIN-2 IN METASTATIC CANCER
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DOI：
10.1016/0959-8049(93)90044-g
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发表时间：
1993-01-01
影响因子：
8.4
通讯作者：
MULDER, NH
中科院分区：
文献类型：
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作者：
BUTER, J;JANSSEN, RAJ;MULDER, NH
在一项I/II期研究中，在15名IL-2治疗失败的癌症患者中研究了OKT 3/白细胞介素2（IL-2）联合治疗的安全性、免疫刺激和抗肿瘤作用。OKT 3以2小时静脉输注的方式给予。研究了50、100、200和400 μ g OKT 3的剂量。在24小时内，开始皮下注射IL-2，每周5天，持续4周，剂量为9-18 × 10（6）U/天。最大耐受剂量为400 pg OKT 3，神经毒性为剂量限制性毒性。皮下注射IL-2的毒性可接受。在最大耐受剂量下，9例具有可测量疾病的肾细胞癌患者在II期环境中接受治疗。8例患者可评价缓解。4例患者病情稳定，4例患者病情进展。活化的淋巴细胞亚群的增加不能被发现，虽然OKT 3在体内淋巴细胞上是可检测的。只有实验室研究揭示了改善OKT 3免疫刺激作用的方法，才有必要进行进一步的临床研究。
In a phase I/II study the safety, immunostimulatory and antitumour effects of a combined OKT3/interleukin 2 (IL-2) treatment was studied in 15 cancer patients who failed IL-2 treatment. OKT3 was given as a 2-h intravenous infusion. Doses of 50, 100, 200 and 400 mug OKT3 were studied. Within 24 h, subcutaneous IL-2 was started 5 days/week for 4 weeks, at a dose of 9-18 x 10(6) U daily. Maximum tolerated dose was 400 pg OKT3 with neurotoxicity as dose-limiting toxicity. Toxicity of subcutaneous IL-2 was acceptable. At the maximum tolerated dose, 9 patients with renal cell carcinoma with measurable disease were treated in a phase II setting. 8 patients were evaluable for response. 4 patients had stable disease and 4 had progressive disease. An increase of activated lymphocyte subpopulations could not be found, although OKT3 was detectable on lymphocytes in vivo. Only if laboratory studies shed light on methods of improving immunostimulating effects of OKT3 will further clinical studies be warranted.