NCT00612066

Rosiglitazone in Treating Patients With Newly Diagnosed ACTH-Secreting Pituitary Tumor (Cushing Disease)

An Open Label, Multicenter Study Evaluating the Safety and Efficacy of Short Term (6 Weeks) Rosiglitazone Treatment in Patient's With Cushing's Disease

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cushing's Disease

Interventions

Type	Name	Description
DRUG	rosiglitazone maleate

Timeline

• Start date: 2007-04-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2008-02-11
• Last updated: 2020-08-06
• Results posted: 2016-02-17

Locations

1 site across 1 country: United States