PEGA-0435-005

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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