CHP 601--TALL 104 CELLS IN CHILDREN WITH ADVANCED RECURRENT REFRACTORY CANCER

我们治疗了3例难治性和/或治疗相关性白血病患者和10例实体瘤患者，其中5例为CNS肿瘤。在白血病患者中，未观察到3级或4级毒性，在1例患者中发现外周原始细胞计数短暂下降1个对数。 白血病患者接受的最大剂量为3x 106个细胞/kg/天x5。患者内剂量递增设计使我们能够在10例实体瘤患者中的最后4例中达到最大计划剂量1x 108个细胞/kg/天x5天。 两名患者有2级或3级嗜睡，这是自限性的，可能与TALL-104细胞有关。 1名患者出现发热和寒战。 这些演变与细菌感染同时发生，并与内源性细胞因子的大量升高有关。回顾起来，1例患者中最初归因于TALL-104细胞的中性粒细胞增多症和血小板减少症可能是4个月前双干细胞移植后计数不稳定的表现。 该患者在MRI扫描中显示轻微反应，持续约2个月。 第二名患者的血小板被认为降至55，000/mm 3，但这被证明是人为因素，因为涂片上有正常数量的凝集血小板。3例CNS肿瘤患者发生2级嗜睡。

We have treated 3 patients with refractory and/or treatment related leukemia and 10 patients with solid tumors, of whom 5 had CNS tumors. Among the leukemia patients, no grade 3 or 4 toxicity was observed and a fleeting one log reduction in peripheral blast count was found in one patient. The maximal dose received was 3x106 cells/kg/day x 5 in leukemia patients. An intrapatient dose-escalation design allowed us to reach the maximal planned dose of 1x108 cells/kg/day x 5 days in the last 4 of the 10 solid tumor patients. Two patients had grade 2 or 3 somnolence that was self-limited and may have been related to the TALL-104 cells. One patient developed fever and rigors. These evolved concurrently with bacteremias and were associated with substantial elevations of endogenous cytokines. Neutropenia and thrombocytopenia originally attributed to TALL-104 cells in one patient were, in retrospect, probably a manifestation of labile counts since a double stem cell transplant 4 months before. This patient showed a minor response on MRI scan which lasted about 2 months. A second patient was thought to have platelets fall to 55,000/mm3 but this turned out to be an artifact as there were normal numbers of clumped platelets on smear. Three patients with CNS tumors experienced grade 2 somnolence.