Clinical Trials Logo

Clinical Trial 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).


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00612066
Study type Interventional
Source Jonsson Comprehensive Cancer Center
Contact
Status Terminated
Phase Phase 2
Start date April 2007
Completion date November 2010

See also
  Status Clinical Trial Phase
Terminated NCT00881283 - Long-term Cardiovascular Risk in Cured Cushing's Patients
Completed NCT02568982 - Cushing's Disease Complications
Completed NCT02697734 - Efficacy and Safety Evaluation of Osilodrostat in Cushing's Disease Phase 3
Completed NCT01374906 - Efficacy and Safety of Pasireotide Administered Monthly in Patients With Cushing's Disease Phase 3
Recruiting NCT03364803 - Collecting Information About Treatment Results for Patients With Cushing's Syndrome
Not yet recruiting NCT02603653 - Assessment of Persistent Cognitive Impairment After Cure of Cushing's Disease N/A
Completed NCT01371565 - Compassionate Use of CORLUX® (Mifepristone) in the Treatment of Signs and Symptoms of Endogenous Cushing's Syndrome Phase 3
Recruiting NCT00845351 - Preoperative Bexarotene Treatment for Cushing's Disease Phase 1/Phase 2
Completed NCT00889525 - Study of Cabergoline in Treatment of Corticotroph Pituitary Tumor Phase 3
Completed NCT02060383 - Study of Management of Pasireotide-induced Hyperglycemia in Adult Patients With Cushing's Disease or Acromegaly Phase 4
Recruiting NCT03474601 - Seoul National University Pituitary Disease Cohort Study
Recruiting NCT04339751 - Effect of Vorinostat on ACTH Producing Pituitary Adenomas in Cushing s Disease Phase 2
Not yet recruiting NCT04569591 - Corticotrophin-releasing Hormone (CRH) Stimulation for 18F-FDG-PET Detection of Pituitary Adenoma in Cushing s Disease N/A
Recruiting NCT02484755 - Targeted Therapy With Gefitinib in Patients With USP8-mutated Cushing's Disease Phase 2
Completed NCT01794793 - Study to Allow Access to Pasireotide for Patients Benefiting From Pasireotide Treatment in Novartis-sponsored Studies Phase 4
Completed NCT00434148 - Safety and Efficacy of Different Dose Levels of Pasireotide in Patients With de Novo, Persistent or Recurrent Cushing's Disease Phase 3
Completed NCT03346954 - Impact of [11C]-Methionine PET/MRI in the Detection of Pituitary Adenomas Secreting ACTH and Causing Cushing's Disease N/A
Withdrawn NCT01925092 - Mifepristone in Children With Refractory Cushing's Disease Phase 3
Completed NCT01582061 - An Open-label, Multi-center, Expanded Access Study of Pasireotide s.c. in Patients With Cushing's Disease. Phase 3
Recruiting NCT03708900 - Pharmacokinetic (PK), Pharmacodynamic (PD) and Tolerability of Osilodrostat in Pediatric Patients With Cushing's Disease Phase 2