PHASE I/II TRIAL OF ARSENIC TRIOXIDE AND TEMOZOLOMIDE WITH RADIATION THERAPY

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 患者被要求参与这项临床研究，因为他们患有恶性胶质瘤(脑瘤)。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。这项研究涉及三氧化二砷(ATO)和替莫唑胺(TMZ)联合放射治疗。ATO被食品和药物管理局(FDA)批准用于治疗已复发或对标准治疗无效的急性早幼粒细胞白血病，但FDA未批准用于恶性胶质瘤。TMZ是FDA批准用于治疗复发间变性星形细胞瘤(一种脑瘤)的成人患者，这些患者放射治疗失败，在某些情况下化疗失败。当它们一起使用时，这些药物中的每一种似乎都能提高放射治疗的有效性(在实验室或在人体中)，然而这种组合被认为是实验性的，因为它没有得到FDA的批准。 这项研究的目的是评估研究治疗对受试者和他/她的脑瘤的影响(好的和坏的)。这项研究的第一阶段将确定ATO和TMZ可与辐射一起使用的安全剂量。这项研究的第二阶段将确定这种组合在治疗受试者脑瘤方面的效果。

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.