This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor 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, physican 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 lavels 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.At the present there is no treament that is available for the treatment of Cushing's Disease due to a pituitary tumor or a non-secreting pituitary tumor that will decrease the size of these tumors. Studies done have shown that Rosiglitazone may have the potentail to decrease the size of these tumors. The study will be clearly described to the potential participants including the possible benefits and sides effects of the medications. The benefits may include decrease in size of the tumor in all participants and decrease in the cortisol levels in patients with Cushing's syndrome. The side effects of Rosiglitazone is well done because it is approved for type 2 Diabetes Mellitus and may includ fluid retentaion, very uncommonly liver diysfunction and anemia. These side effects will be monitored closely and the study medication stopped if any of the side effects develop.
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