Conditions: Cushing's Disease
Keywords: ACTH-producing pituitary tumor
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 2
Healthy volunteers: no

Brief summary:
RATIONALE: Rosiglitazone may help pituitary tumor cells become more like normal cells, and to grow and spread more slowly.

PURPOSE: This phase II trial is studying how well rosiglitazone works in treating patients with newly diagnosed ACTH-secreting pituitary tumor (Cushing disease).

Detailed description:
OBJECTIVES:

Primary

* To assess the effect of rosiglitazone on biochemical control in patients with newly diagnosed ACTH-secreting pituitary tumor (Cushing disease).

Secondary

* To assess the effect of this drug on corticotrophin (CRH)-stimulated pituitary tumor ACTH secretion.
* To assess the overall safety and tolerability of this drug in these patients.
* To assess the overall quality of life of patients treated with this drug.
* Percentage of Reduction in 24-hour Urinary-free Cortisol Levels

OUTLINE: This is a multicenter study.

Patients receive oral rosiglitazone once daily for 7 weeks in the absence of disease progression or unacceptable toxicity.

Blood, urine, and saliva samples are collected periodically for laboratory studies. Inflammatory markers (C-reactive protein, interleukin-6 \[IL-6\], serum sialic acid, soluble intracellular and vascular adhesion molecules \[sICAM-1, and sVCAM-1\], and amyloid A) are measured at baseline and at the completion of study treatment; salivary cortisol and 24-hour urinary-free cortisol levels are measured at baseline and weekly during study treatment; dexamethasone suppression tests with serum cortisol and corticotrophin (CRH) stimulation test are performed at baseline and at the completion of study treatment; prolactin, insulin-like growth factor-1 (IGF1), thyroid function, and sex steroid hormones are measured at baseline and at the completion of study treatment; and dynamic pituitary function testing (arginine/growth hormone-releasing hormone \[GHRH\] testing to measure growth hormone secretion) is performed at baseline.

Arms:
arm 1: None

Interventions: intervention 1: rosiglitazone maleate
Intervention descriptions: intervention 1: None

Protocol document: