Wallack M K, McNally K R, Leftheriotis E, Seigler H, Balch C, Wanebo H, Bartolucci A A, Bash J A
Cancer. 1986 Feb 1;57(3):649-55. doi: 10.1002/1097-0142(19860201)57:3<649::aid-cncr2820570342>3.0.co;2-6.
Vaccinia melanoma oncolysates (VMO) were tested in a Southeastern Cancer Study Group (SECSG) Phase I/II trial. Forty-eight patients with high-risk Stage I or pathologic Stage II disease were placed on study at six different dose levels and two different treatment regimens. Patients were monitored for toxicity to the VMO after each injection. Patients' sera were tested for anti-human melanoma reactivity with the Staphylococcus Protein A (SpA) assay. Toxicity was minimal at all doses tested. In only 2 of 19 patients on delayed treatment did reactivity develop in the SpA assay by 6 months. However, 13 of 23 patients on immediate treatment showed reactivity, including 8 of 8 at the two highest doses. Since the VMO appears to be safe at all of the doses tested, and because of the immunogenicity of the VMO at the higher doses as demonstrated by the SpA assay, the 2-mg dose level, for immediate treatment, was chosen for use in future trials.
痘苗黑素瘤溶瘤产物（VMO）在东南癌症研究组（SECSG）的I/II期试验中进行了测试。48例高危I期或病理II期疾病患者在六个不同剂量水平和两种不同治疗方案下进行研究。每次注射后监测患者对VMO的毒性。用葡萄球菌蛋白A（SpA）试验检测患者血清的抗人黑素瘤反应性。在所有测试剂量下毒性均最小。在延迟治疗的19例患者中，仅2例在6个月时SpA试验出现反应性。然而，在立即治疗的23例患者中，13例出现反应性，包括在两个最高剂量下的8例中的8例。由于VMO在所有测试剂量下似乎都是安全的，并且如SpA试验所示，VMO在较高剂量下具有免疫原性，因此选择2mg剂量水平用于立即治疗，以供未来试验使用。
