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.
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