PEGA-0435-005

PEGA-0435-005

• 批准号: 7376565
• 负责人: ARIEL Lev BARKAN
• 金额: $ 0.15万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-04-05 至 2007-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7376565
• 关键词: experience; neoplasm /cancer; octreotide; somatostatin

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. Acromegaly is an extremely rare disease caused by a tumor in the pituitary. The pituitary tumor causes increased secretion of Growth Hormone. This in turn leads to elevated levels of Insulin-Like Growth Factor 1 (IGF-1). Research indicates that most of the symptoms and health problems experienced in Acromegaly are a result of increased IGF-1. Thus, one goal of acromegaly treatment is to control levels of IGF-1. The purpose of this study is to learn more about the two most effective approved medications for treatment of acromegaly: Pegvisomant and Sandostatin. Previous experience in our most recent Acromegaly study showed that some patients needed a combination of both Sandostatin and Pegvisomant to adequately control their full range of symptoms. The two medications work in different ways, but both are effective for some acromegaly patients. This study will help determine the safety and tolerability of combination therapy. To participate, patients must be adults diagnosed with acromegaly. Participants must have been previously treated with radiation or surgery, without full control of their symptoms. Pregnant patients should also not participate. Some patients will receive the approved medication Somavert (Pegvisomant) alone, and others will receive both Pegvisomant the approved medication Sandostatin LAR Depot. A third group of patients, who have demonstrated a good response to Sandostatin LAR therapy, will continue taking their Sandostatin LAR and serve as a safety control group. Treatment will be assigned randomly, like flipping a coin. Participants will have monthly blood draws during the 40-week study, and the study will examine the safety and tolerability of each regimen. This will be measured by examining the number and type of adverse events in each group. The study will also measure quality of life and patients' perceptions of their signs and symptoms in each group, as well as effectiveness in controlling IGF-1

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。肢端肥大症是一种非常罕见的疾病，由垂体肿瘤引起。垂体瘤导致生长激素分泌增加。这反过来又导致胰岛素样生长因子1（IGF-1）水平升高。研究表明，肢端肥大症的大多数症状和健康问题都是IGF-1增加的结果。因此，肢端肥大症治疗的一个目标是控制IGF-1的水平。这项研究的目的是了解更多关于两种最有效的批准药物治疗肢端肥大症：培维索芒和善得定。在我们最近的肢端肥大症研究中，以往的经验表明，一些患者需要善得定和培维索芒的组合来充分控制他们的全方位症状。这两种药物以不同的方式起作用，但对某些肢端肥大症患者都有效。这项研究将有助于确定联合治疗的安全性和耐受性。参与者必须是被诊断患有肢端肥大症的成年人。参与者必须以前接受过放射治疗或手术治疗，没有完全控制他们的症状。孕妇也不应该参加。一些患者将单独接受批准的药物Somavert（Pegvisomant），其他患者将接受Pegvisomant和批准的药物Sandostatin LAR Depot。第三组患者对善得定LAR治疗反应良好，将继续服用善得定LAR，并作为安全性对照组。治疗将随机分配，就像抛硬币一样。在为期40周的研究期间，参与者将每月抽血，研究将检查每种方案的安全性和耐受性。这将通过检查各组不良事件的数量和类型来衡量。该研究还将测量各组患者的生活质量和患者对其体征和症状的感知，以及控制IGF-1的有效性