Rosiglitazone in Treating Patients With Pituitary Tumors (NCT00616642) | Clinical Trial Compass
TerminatedPhase 2
Rosiglitazone in Treating Patients With Pituitary Tumors
Stopped: low patient recruitment
United States1 participantsStarted 2006-10
Plain-language summary
RATIONALE: Rosiglitazone may help pituitary adenoma cells become more like normal cells, and grow and spread more slowly.
PURPOSE: This phase II trial is studying how well rosiglitazone works in treating patients with newly diagnosed or residual or recurrent pituitary adenoma.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Clinically demonstrable pituitary tumor, including either of the following subtypes:
* ACTH-secreting adenoma
* Residual or recurrent disease ≥ 1 month after prior pituitary surgery
* Clinically demonstrable tumor, as evidenced by both of the following:
* Elevated 24-hour urinary free cortisol (UFC) level
* Lack of suppression of 8 a.m. serum cortisol to \< 1.8 µg/dL after administration of dexamethasone 1 mg at 11 p.m. the previous night
* Tumor demonstrated by MRI performed with and without contrast and/or by inferior petrosal sinus sampling with evidence of a central ACTH source.
* Normal visual field evaluation by Goldman perimetry
* Hypopituitarism allowed as evidenced by any or all of the following:
* Subnormal growth hormone (GH) response to arginine/GH-releasing hormone testing (normal response is an increase of 2-6 ng/me)
* Low age and sex-matched IGF-1 levels
* Low thyroid-stimulating hormone, free triiodothyronine, and free thyroxine levels
* Low estradiol levels
* Low leuteinizing hormone (LH) and low follicle-stimulating hormone (FSH) levels in post-menopausal female patients OR low testosterone, LH, and FSH levels in male patients
* Patients with Cushing disease (i.e., harboring ACTH-secreting pituitary adenomas) must meet the following criteria:
* Hypercortisolemic (i.e., uncured) despite ≥ 1 pituitary surgery
* Refuse to undergo pituitary irradiation and/or bilateral adrenalectomy
* Refuse alternate steroid-lowering therapy…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Efficacy of Rosiglitazone Maleate on Cushing Disease