Mittelman A, Urban R, Wong G, Ahmed T, Arlin Z
New York Medical College, Valhalla.
Cancer Immunol Immunother. 1992;35(5):331-4. doi: 10.1007/BF01741146.
ImuVert, a new biological response modifier, was evaluated for toxicity and potential efficacy in patients with advanced cancer. This agent consists of sized, labile, natural membrane vesicles associated with ribosomes derived from Serratia marcescens. ImuVert induces enhanced in vitro macrophage and natural-killer-cell-mediated cytotoxicity, and has demonstrated antitumor activity in palpable animal tumor systems. A group of 39 patients with a variety of tumors, 25 men, 14 women, with a mean performance status (Karnofsky) of 80% and median age of 57 years were entered into this trial. ImuVert was administered subcutaneously weekly for a minimum of 3 weeks. A total of 183 treatments were evaluated. Flu-like systemic toxicities, including fever, chills, nausea, vomiting, diarrhea and hypotension were observed. Erythema, induration and tenderness developed at the injection sites. Myelosuppression, thrombocytopenia, anaphylaxis, rental and hepatic toxicities did not occur. All symptoms resolved within 24 h. Two patients with nodular lymphoma achieved a partial response and two minor responses were seen in patients with glioblastoma and melanoma. On the basis of ImuVert's biological activity, and tolerable toxicity it warrants further clinical investigation.
新型生物反应调节剂ImuVert在晚期癌症患者中进行了毒性和潜在疗效评估。该制剂由大小合适、不稳定的天然膜泡组成，这些膜泡与源自粘质沙雷氏菌的核糖体相关联。ImuVert可增强体外巨噬细胞和自然杀伤细胞介导的细胞毒性，并在可触及的动物肿瘤模型中显示出抗肿瘤活性。一组39例患有各种肿瘤的患者进入该试验，其中男性25例，女性14例，平均体能状态（卡诺夫斯基评分）为80%，中位年龄为57岁。ImuVert每周皮下注射一次，至少注射3周。共评估了183次治疗。观察到类似流感的全身毒性，包括发热、寒战、恶心、呕吐、腹泻和低血压。注射部位出现红斑、硬结和压痛。未发生骨髓抑制、血小板减少、过敏反应、肾毒性和肝毒性。所有症状在24小时内缓解。两名结节性淋巴瘤患者获得部分缓解，胶质母细胞瘤和黑色素瘤患者有两名出现轻微缓解。基于ImuVert的生物活性和可耐受的毒性，值得进一步开展临床研究。
