CLINICAL TRIAL: PHASE I DOSE ESCALATION STUDY OF AUTOLOGOUS TUMOR LYSATE-PULSED

该子项目是利用 由NIH/NCRR资助的中心赠款提供的资源。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。列出的机构是 中心，不一定是研究者的机构。 具体目标： 本研究的主要目的是： 确定在所述剂量递增方案中是否达到剂量限制性毒性（DLT），使用皮内注射从外周血前体中收获的自体树突状细胞，并用从恶性胶质瘤患者的手术组织中采集的肿瘤裂解物进行脉冲（共培养）。 如果达到DLT，则将定义最大耐受剂量（MTD）。 本研究的次要目的是： 监测注射肿瘤裂解物脉冲树突状细胞的脑肿瘤患者的存活率、肿瘤进展和细胞免疫应答。

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. SPECIFIC AIMS: The primary objective of the study is: To determine if Dose Limiting Toxicity (DLT) is reached in the dose escalation scheme described, using intradermal injections of autologous dendritic cells harvested from peripheral blood precursors and pulsed (co-cultured) with tumor lysate taken from surgical tissues in patients with malignant gliomas. If DLT is reached, then Maximum tolerated Dose (MTD) will be defined. Secondary objectives of this study are: To monitor survival, tumor progression and cellular immune responses in brain tumor patients injected with tumor lysate-pulsed dendritic cells.