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首页> 外文期刊>Journal of Clinical Oncology >Active specific immunotherapy of metastatic melanoma with an antiidiotype vaccine: a phase I/II trial of I-Mel-2 plus SAF-m.
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Active specific immunotherapy of metastatic melanoma with an antiidiotype vaccine: a phase I/II trial of I-Mel-2 plus SAF-m.

机译：用抗独特型疫苗进行转移性黑色素瘤的主动特异性免疫治疗：I-Mel-2加SAF-m的I / II期试验。

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PURPOSE: To determine the toxicity and immunologic activity of an antiidiotype melanoma vaccine that consists of monoclonal antibody I-Mel-2 (MELIMMUNE-2, IDEC Pharmaceuticals, La Jolla, CA) and an immunologic adjuvant SAF-m. PATIENTS AND METHODS: Twenty-six patients with metastatic melanoma, 17 of whom had previously received chemotherapy, were given 2 mg of I-Mel-2 and either 100 micrograms (n = 6) or 250 micrograms (n = 20) of SAF-m. Antiidiotype vaccine was given intramuscularly (IM) biweekly for 4 weeks, and then bimonthly until disease progression. Human antimurine antibodies (HAMA), anti-I-Mel-2 antibodies, and specific antibody (Ab)3 against the melanoma epitope mimicked by the vaccine were titrated before treatment, biweekly from weeks 4 to 12, and every 4 to 8 weeks thereafter. Computed tomographic (CT) scans of the chest, abdomen, and pelvis and magnetic resonance imaging (MRI) of the brain were obtained before and bimonthly during treatment to evaluate responses. RESULTS: Elevated titers ofhuman antimouse antibodies and anti-I-Mel-2 antibodies were associated with clinical antitumor effect (P = .02 and P = .05, respectively). Ab3 was absent in most patients, but was found in the best clinical responder. Fever, myalgias/arthralgias, fatigue, nausea, and headaches were the most common toxicities. Grade III myalgias/arthralgias and headaches required dose reduction of SAF-m in eight patients at the 250-microgram dose. No treatment-related death occurred. Six patients had an antitumor effect: one complete response in liver and lung, two minor responses, and three stable disease. The patient with a complete response has survived nearly 5 years. CONCLUSION: I-Mel-2 antiidiotype vaccine was safe, tolerated best at the 100-microgram dose of SAF-m, and had immunologic and clinical activity.
机译：目的：确定由单克隆抗体I-Mel-2（MELIMMUNE-2，IDEC Pharmaceuticals，La Jolla，CA）和免疫佐剂SAF-m组成的抗独特型黑素瘤疫苗的毒性和免疫活性。患者和方法：26例转移性黑色素瘤患者（其中17例曾接受过化疗）接受了2 mg I-Mel-2的治疗，以及100毫克（n = 6）或250毫克（n = 20）的SAF-米每两周肌肉注射一次（IM）抗独特型疫苗，持续4周，然后每两个月一次，直到疾病进展。在治疗前，第4周至第12周每两周滴定人源抗鼠类抗体（HAMA），抗I-Mel-2抗体和针对由疫苗模拟的黑色素瘤抗原表位的特异性抗体（Ab）3，此后每隔4周至8周滴定一次。在治疗之前和治疗过程中每两个月进行一次胸部，腹部和骨盆的计算机断层扫描（CT）扫描以及大脑的磁共振成像（MRI），以评估反应。结果：人抗鼠抗体和抗I-Mel-2抗体滴度升高与临床抗肿瘤作用有关（分别为P = .02和P = .05）。大多数患者中都不存在Ab3，但在最佳临床应答者中发现了Ab3。发烧，肌痛/关节痛，疲劳，恶心和头痛是最常见的毒性。 III级肌痛/关节痛和头痛需要以250微克的剂量降低8位患者的SAF-m剂量。没有发生与治疗有关的死亡。 6例患者具有抗肿瘤作用：1例在肝和肺完全缓解，2例轻微缓解，3例稳定。反应完全的患者存活了将近5年。结论：I-Mel-2抗独特型疫苗是安全的，在SAF-m剂量为100微克时耐受性最好，并且具有免疫学和临床活性。

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