IMPLANTATION/MOUSE RENAL ADENOCARCINOMA/MACROBEADS/CANCER

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心机构，不一定为研究者机构。本研究的目的是评价6- 8 mm琼脂糖-琼脂糖大珠（含有小鼠肾腺癌细胞（RENCA细胞））在10名患有终末期、治疗耐药的起源于腹膜腔的上皮源性癌症的人类患者中的安全性和毒性，为期6个月。在小鼠模型和兽医患者研究中，大珠粒已显示出作为体外和体内广泛的上皮来源的癌症的抑制剂的前景，将以每千克8个大珠粒（5名患者）和每千克16个大珠粒（5名患者）的剂量水平植入这些患者的腹膜腔中。基于迄今为止的进展和缺乏与大珠相关的任何显著毒性的证据（与其终末期潜在恶性疾病过程的并发症相反），我们预计在接下来的几个月内增加进入研究的人数，当然，等待FDA和IRB批准这种加速时间表。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The purpose of this study is to evaluate the safety and toxicity of a 6-8mm agarose-agarose macrobead containing mouse renal adenocarcinoma cells (RENCA cells) in ten human patients with end-stage, treatment-resistant epithelial-derived cancer originating in the peritoneal cavity over a six-month period. The macrobeads, which have shown promise as inhibitors of a broad-range of epithelial-derived cancers both in vitro and vivo in murine models and veterinary patient studies, will be implanted in the peritoneal cavities of these patients at dosage levels of 8 macrobeads per kilogram (5 patients) and 16 macrobeads per kilogram (5 patients). Based on the progress to date and the absence of evidence of any significant toxicity directed related to the macrobeads (as opposed to complications of the underlying malignant disease process in its end-stages), we expect to increase entry into the study over the next several months, pending, of course, FDA and IRB approval of such an accelerated schedule.