An Open Label, Multicenter Study Evaluating the Safety and Efficacy of Short Term (6 Weeks) Rosiglitazone Treatment in Patient's With Cushing's Disease
- To assess the effect of rosiglitazone on biochemical control in patients with newly
diagnosed ACTH-secreting pituitary tumor (Cushing disease).
- To assess the effect of this drug on a core biochemical parameter (24-hour urinary-free
cortisol) associated with disease progression.
- To assess the effect of this drug on corticotrophin (CRH)-stimulated pituitary tumor
- 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.
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.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Percentage of responders
Anthony Heaney, MD
Jonsson Comprehensive Cancer Center
United States: Food and Drug Administration
|Jonsson Comprehensive Cancer Center at UCLA||Los Angeles, California 90095-1781|