Rosiglitazone in Treating Patients With Newly Diagnosed ACTH-Secreting Pituitary Tumor (Cushing Disease)
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|ClinicalTrials.gov Identifier: NCT00612066|
Recruitment Status : Terminated (Low accrual and funding term ended)
First Posted : February 11, 2008
Results First Posted : February 17, 2016
Last Update Posted : February 17, 2016
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).
|Condition or disease||Intervention/treatment||Phase|
|Cushing's Disease||Drug: rosiglitazone maleate||Phase 2|
- 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 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label, Multicenter Study Evaluating the Safety and Efficacy of Short Term (6 Weeks) Rosiglitazone Treatment in Patient's With Cushing's Disease|
|Study Start Date :||April 2007|
|Primary Completion Date :||November 2010|
|Study Completion Date :||November 2010|
U.S. FDA Resources
|Experimental: Rosiglitazone||Drug: rosiglitazone maleate|
- Number of Responders [ Time Frame: 7 weeks ]
Definition of Treatment Response
- The primary outcome in Cushing's disease will the % responders, a responder is defined as a patient with 2 consecutive 24h urinary free cortisols within the normal reference range in association with no clinical signs of disease progression.
- Secondary outcomes will include the % reduction in 24h UFC (derived by comparison of the mean of 2 baseline 24h UFC values with mean of the two lowest consecutive 24h UFC values while on study treatment in association with no clinical signs of disease progression).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00612066
|United States, California|
|Jonsson Comprehensive Cancer Center at UCLA|
|Los Angeles, California, United States, 90095-1781|
|Principal Investigator:||Anthony Heaney, MD||Jonsson Comprehensive Cancer Center|