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

这个子项目是众多研究子项目之一

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.