Wallack M K, Meyer M, Bourgoin A, Doré J F, Leftheriotis E, Carcagne J, Koprowski H
J Biol Response Mod. 1983;2(6):586-96.
A preliminary trial was designed as a toxicity/feasibility study using a fixed dose of vaccinia melanoma oncolysates (VMO) to treat recurrent stage II and stage III (skin, subcutaneous, and nodal metastases only) melanoma. There were no adverse consequences of the therapy, and 4 of the 12 patients treated seemed to have responded to the treatment by the criteria of the study. Sera from the six patients with the longest survival showed immunoreactivity to human melanoma lines in a Staphylococcus protein A assay (SpA) after 3 months of therapy. While the specificity of this immunoreactivity remains to be determined, the discovery of posttreatment serologic activity in a SpA assay permits investigation of the degree of VMO immunostimulation at different dose levels of the biologic. This assay may provide the means to quantitate optimal biologic dose for future melanoma oncolysate trials. The Southeastern Cancer Study Group is now conducting a phase I/II trial with these vaccinia melanoma oncolysates using the SpA assay to monitor this trial.
一项初步试验被设计为一项毒性/可行性研究，使用固定剂量的痘苗黑色素瘤溶瘤物（VMO）来治疗复发性II期和III期（仅皮肤、皮下和淋巴结转移）黑色素瘤。该治疗没有不良后果，按照研究标准，接受治疗的12名患者中有4名似乎对治疗有反应。治疗3个月后，在葡萄球菌蛋白A检测（SpA）中，6名存活时间最长的患者的血清对人黑色素瘤细胞系显示出免疫反应性。虽然这种免疫反应性的特异性仍有待确定，但在SpA检测中发现治疗后的血清学活性允许对该生物制剂不同剂量水平下的VMO免疫刺激程度进行研究。该检测可能为未来黑色素瘤溶瘤物试验中最佳生物剂量的定量提供方法。东南癌症研究组目前正在使用SpA检测对这些痘苗黑色素瘤溶瘤物进行I/II期试验，以监测该试验。
