NU 04C1-PHASE I/II TRIAL OF ARSENIC TRIOXIDE, TEMOZOLOMIDE, RT FOR GLIOMA

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，不一定是研究者所在机构。患者被要求参加这项临床研究，因为他们患有恶性胶质瘤（脑肿瘤）。目前的治疗方法可以治疗这种类型的癌症，但在大多数情况下，肿瘤会复发。本研究涉及放射治疗与Trisenox（三氧化二砷，ATO）和Temodar（替莫唑胺，TMZ）的组合。ATO被美国食品和药物管理局（FDA）批准用于治疗急性早幼粒细胞白血病，这些白血病已经复发或对标准治疗没有反应，但FDA没有批准用于恶性胶质瘤。TMZ被FDA批准用于治疗复发性间变性星形细胞瘤（一种脑肿瘤）的成人患者，这些患者的放射治疗和某些情况下的化疗失败。当它们一起使用时，这些药物中的每一种似乎都会增加放射治疗的有效性（在实验室或人体中），但是这种组合被认为是实验性的，因为它尚未得到FDA的批准。 本研究的目的是评价研究治疗对受试者及其脑肿瘤的影响（良好和不良）。这项研究的第一阶段将确定ATO和TMZ的安全剂量，可用于辐射。本研究的第二阶段将确定这种组合在治疗受试者的脑肿瘤方面的有效性。

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. Patients are being asked to participate in this clinical research study because they have a malignant glioma (a brain tumor). Current treatments can treat this type of cancer but in most cases the tumor returns. This study involves the combination of radiation therapy with Trisenox (arsenic trioxide, ATO) and Temodar (temozolomide, TMZ). ATO is approved by the Food and Drug Administration (FDA) to treat acute promylocytic leukemia that has returned or is not responding to standard therapy but is not FDA approved for malignant gliomas. TMZ is FDA approved for the treatment of adult patients with recurrent anaplastic astrocytoma (a type of brain tumor) who have failed radiation therapy and in some cases chemotherapy. Each of these drugs appears to increase the effectiveness of radiation therapy (in the laboratory or in people) when they are used together, however this combination is considered experimental as it has not been approved by the FDA. The purpose of this study is to evaluate the effects (good and bad) the study treatment has on the subject and his/her brain tumor. The first phase of this study will determine the safe dose of ATO and TMZ that can be used with radiation. The second phase of this study will determine how effective this combination is at treating the subject's brain tumor.