Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2026-01-02 @ 8:34 AM
Study NCT ID:
NCT00612066
Status:
TERMINATED
Last Update Posted:
2020-08-06
First Post:
2008-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Rosiglitazone in Treating Patients With Newly Diagnosed ACTH-Secreting Pituitary Tumor (Cushing Disease)
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low accrual and funding term ended
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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).
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| UCLA-0612080-01 | None | None | View |