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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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 : August 6, 2020
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

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).

Condition or disease Intervention/treatment Phase
Cushing's Disease Drug: rosiglitazone maleate Phase 2

Detailed Description:



  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Arm Intervention/treatment
Experimental: Rosiglitazone Drug: rosiglitazone maleate

Primary Outcome Measures :
  1. 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).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Clinically demonstrable ACTH-secreting pituitary tumor

    • Pituitary tumor demonstrated on MRI with and without contrast AND/OR evidence of a central ACTH source following inferior petrosal sinus sampling
    • Newly diagnosed disease
  • Biochemically active disease that is not adequately controlled, as demonstrated by the following standard criteria:

    • Elevated 24-hour urinary-free cortisol levels on at least 2 separate 24-hour urine collections 1 week apart
    • Lack of suppression of serum cortisol to < 1.8 μg/dL (at 8 am) following administration of 1 mg of dexamethasone at 11 pm the night before
    • Measurable plasma ACTH levels
  • Patient is hypercortisolemic and does not wish to receive alternate steroid-lowering therapy, such as ketoconazole and/or metyrapone
  • Patients with evidence of optic nerve or chiasm compression on post-operative MRI must have a normal visual field evaluation by Goldman perimetry

    • No visual field abnormalities
  • Hypopituitarism* allowed, as evidenced by any or all of the following:

    • Subnormal growth hormone (GH) response to arginine/growth hormone-releasing hormone (GHRH) testing (normal response is an increase of > 4 ng/mL)
    • Low age-and sex-matched insulin-like growth factor-1 (IGF-1) levels
    • Low thyroid-stimulating hormone (TSH) levels
    • Low free triiodothyronine (T3) and free thyroxine (T4) levels
    • Low estradiol levels
    • Low luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels in postmenopausal female patients
    • Low testosterone, LH, and FSH levels in male patients NOTE: *Patients who are diagnosed with hypopituitarism will initiate thyroid hormone replacement therapy prior to pituitary surgery as part of routine care. Other hormone replacement, such as sex steroids or growth hormone, will not be initiated during the study.


  • Not pregnant or nursing
  • Fertile patients must use effective contraception (if oral contraception is used, it must be used for ≥ 2 months prior to, during, and for 1 month after completion of study therapy)
  • No clinically significant renal, hematologic, or hepatic abnormalities
  • No prior or concurrent medical condition that may interfere with the conduct of the study or the evaluation of its results, in the opinion of the investigator or the DSMB compliance officer
  • No history of immunocompromise, including HIV positivity by ELISA and western blot
  • No alcohol or drug abuse within the past 6 months
  • No blood donation (≥ 400 mL) within the past 2 months
  • No other active malignant disease within the past 5 years except for basal cell carcinoma or carcinoma in situ of the cervix
  • No active or suspected acute or chronic uncontrolled infection
  • No severe osteoporosis, defined as bone mineral density T scores < 2.5 standard deviations below age-matched controls
  • No history of noncompliance to medical regimens
  • Considered reliable
  • Able to complete the entire study


  • More than 3 months since prior rosiglitazone or other thiazolidinedione
  • No prior or concurrent radiotherapy for pituitary tumor
  • More than 1 month since prior participation in any clinical investigation involving an investigational drug
  • More than 30 days since prior unlicensed drugs
  • No concurrent pituitary surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00612066

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United States, California
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Institutes of Health (NIH)
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Principal Investigator: Anthony Heaney, MD Jonsson Comprehensive Cancer Center
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Responsible Party: Jonsson Comprehensive Cancer Center Identifier: NCT00612066    
Other Study ID Numbers: CDR0000586468
First Posted: February 11, 2008    Key Record Dates
Results First Posted: February 17, 2016
Last Update Posted: August 6, 2020
Last Verified: January 2016
Keywords provided by Jonsson Comprehensive Cancer Center:
ACTH-producing pituitary tumor
Additional relevant MeSH terms:
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ACTH-Secreting Pituitary Adenoma
Pituitary ACTH Hypersecretion
Pituitary Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hypothalamic Diseases
Pituitary Diseases
Endocrine System Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Hypoglycemic Agents
Physiological Effects of Drugs