AN OPEN-LABEL, MULTICENTER, PHASE II STUDY EVALUATING THE SAFETY AND EFFICACY O

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。 这项由美国食品和药物管理局赞助的第二阶段临床试验将考察罗格列酮在15名新诊断的库兴氏病患者、15名在接受垂体手术后仍有活动的库兴氏病患者以及15名新诊断的或在垂体手术后至少3个月后仍有肿瘤残留的非分泌性垂体瘤患者中的潜在治疗作用。 同意的患者将接受详细的基线病史、医生和生化评估，包括测量特定的激素(S)，他们的脑垂体肿瘤产生，以及脑垂体肿瘤大小的核磁共振评估。患者将开始使用罗格列酮(4毫克用于第一周，然后在研究治疗期间每天口服8毫克)，被批准用于糖尿病。每月将重新评估生化和内分泌检查，每6个月进行放射检查，新诊断的库欣患者(目标1)将继续接受罗格列酮治疗，总疗程为6周，脑下垂体手术后皮质醇水平升高的库欣患者为6个月，非分泌性肿瘤患者为12个月。患者的反应将通过随访评估与基线结果的统计比较来确定。 完全反应将被定义为库欣患者的尿皮质醇水平正常化，以及非分泌性肿瘤中的脑垂体肿瘤从基线水平开始消失。

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. This Phase II clinical trial sponsored by the Food and Drug Administration will examine the potential therapeutic role for rosiglitazone in 15 patients with newly diagnosed Cushing's Disease, in 15 patients who still have active Cushing's disease despite pituitary surgery, and in 15 patients with non-secreting pituitary tumors either newly diagnosed or who has residual tumor at least 3 months after pituitary surgery. Consenting patients will undergo a detailed baseline historical, physician and biochemical evaluation, including measurement of the specific hormone(s), their pituitary tumor produces, and an MRI assessment of the pituitary tumor size. Patients will commence treatment with Rosiglitazone, (4 mg for i week and then 8 mg by mouth daily for the duration of the study treatment period) approved for use in diabetes mellitus. Biochemical and endocrine examination will be re-evaluated monthly, radiological examination at 6 months, and rosiglitazone therapy will continue for a total treatment period of 6 weeks in the newly diagnosed Cushing's patients (Aim 1), 6 months in Cushing's patients who had elevated cortisol levels after pituitary surgery and 12 months in patients with non-secreting tumors. Patient response will be determined by a statistical comparison of the follow-up assessments with baseline result. A complete response will be defined as normalization of urinary cortisol levels in the Cushing's patients and disappearance of pituitary tumors in the non-secreting tumors from baseline.